Kreara solutions

CHAPTER 1 INTRODUCTION

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1.1

INTRODUCTION

Organization study is basically refers to the study relates to find out the real functioning of an organization through personnel visiting to the various department of that organization and also by visiting the organizations various operating firm . The study includes meetings and interviews with the various departments heads and also the staff in each department. Every organization has its own objectives and these are differing from each other. Organization study is an important part in MBA program. The major purpose of this study is to understand the organizations structure , policies, programs,functions of the organization by applying theory to practical on the entire organisation. The study conducted at kreara solutons technopark trivandrum.Its a private limited

company. Originally established as a statistical services vendor in April 2004, Kreara soon gained traction in the field of clinical trials and got ourselves well versed with the ICH/GCP and CFR PART 11 regulatory requirements. Since then Kreara has been using custom built software applications and standard statistical packages like SAS for providing end-to-end data management and biometric solutions to the pharmaceutical companies and contract research organizations in India, USA and Europe. Kreara was officially incorporated in April 2004. The company head office situated at technopark and company itself . the organisation doesnot have any branch office in india. The organisation refers to clinical service data analysis and software developing .

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1.2 OBJECTIVES OF THE STUDY

To evaluate the overall performance of the company

To know the objectives and future plans of the firm.

To study the various operations in KREARA SOLUTIONS.

To identify and understand the strength, weakness, opportunities and threats of the organization.

To understand the various departments in the organization.

To know about the functioning of various operations of the firm.

To familiarize with the organizational policies and procedures.

1.3 SCOPE OF THE STUDY

Now a days business has become more competitive and the technology has changed the nature of business and organization. This study analyses in detail about the function of different departments on the basis of which strengths, weaknesses, opportunities and threats are arrived at. The findings of the study would give valuable information about the overall performance of the organization. IMK VARKALA Page 3

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1.4 RESEARCH METHODOLOGY

The study was based on discussion with department heads and the top management of the company. Primary data and secondary data are the two methods used for data collection. 1.4.1 Primary Data

Primary data were obtained through discussion and direct interviews with departmental managers of the organization. 1.4.2 Secondary data In this study secondary data is collected from journals, news papers, magazines, company reports and through websites.

1.5 SIGNIFICANCE OF THE STUDY

The study is conducted to analyze the overall performance of KREARA SOLUTIONS. KREARA SOLUTIONS is a private sector enterprise through which company intends to provide quality service and product at reasonable prices to their clients therefore an attempt is made to study the profitability, value and strength of this company through this period of study.

1.5 LIMITATIONS OF THE STUDY The organization is not ready to disclose all the activities by various Because the company has its own and Page 4

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marketing plan and also the humanresource if they will reveal all the secret of growth and business Duration of study is the main limitation .Only 15 days were allowed for conducting the study. It is not sufficient to understand the whole activities of the various deartments on the organisation.

1.7 CHAPTERISATION
Chapter I - Includes introduction, objectives, scope, methodology, significance and limitations of the study. Chapter II - Includes Industry Profile, the Origin of the industry, its growth and development. Chapter III - Includes Company Profile of KREARA SOLUTIONS, their, mission, their objectives, their quality policy and their product profile. Chapter IV - Puts forward the organizational structure of KREARA SOLUTIONS. Chapter V - Includes Departmental Analysis, the detailed analysis of the various departments of KREARA SOLUTIONS. Chapter VI - Includes the SWOT Analysis and PEST Analysis of the company. Chapter VII - Involves the various findings, conclusion and suggestions about KREARA SOLUTIONS.

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CHAPTER 2 INDUSTRY PROFILE

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2.1 GLOBAL INDUSTRY
Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. The term clinical research refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied. In the United States, when a test article is unapproved or not yet cleared by the FDA, or when an approved or cleared test article is used in a way that may significantly increases the risks (or decreases the acceptability of the risks), the data obtained from the pre-clinical studies or other supporting evidence, case studies of off label use, etc. are submitted in support of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) for review prior to conducting studies that involve even one human and a test article if the results are intended to be submitted to or held for inspection by the FDA at any time in the future (in the case of an already approved test article, if intended to submit or hold for inspection by the FDA in support of a change in labeling or advertising). Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption (IDE) application if the device is a significant risk device or is not in some way exempt from prior submission to the FDA. In addition clinical research may require Institutional Review Board (IRB) or Research Ethics Board (REB) and possibly Other institutional Committee review Privacy Board, Conflict of Interest Committee, Radiation Safety Committee, Radioactive Drug Research Committee, etc. approval whether or not the research requires prior submission to the FDA. Clinical research review criteria will depend on which Federal regulations the IMK VARKALA Page 8

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research is subject to (e.g., [(Department of Health and Human Services)] (DHHS) if Federally funded, FDA as already discussed) and will depend on which regulations the institutions subscribe to, in addition to any more stringent criteria added by the institution possibly in response to state or local laws/policies or accreditation entity recommendations. This additional layer of review (IRB/REB in particular) is critical to the protection of human subjects especially when you consider that often research subject to the FDA regulation for prior submission is allowed to proceed, by those same FDA regulations, 30 days after submission to the FDA unless specifically notified by the FDA not to initiate the study. In the European Union, the European Medicines Agency (EMA) acts in a similar fashion for studies conducted in their region. These human studies are conducted in four phases in research subjects that give consent to participate in the clinical trials. Phase 1 trials Phase 1 trials usually deal with investigating the studied drug in a minor number of research subjects who are healthy volunteers. This phase is mainly targeted at identifying the safety, tolerability, and the general mechanism of the action of the drug in humans. These studies are usually conducted in tightly controlled clinics called CPUs (Central Pharmacological Units), where participants receive 24-hour medical attention and oversight. In some diseases in which the therapy under study is known to be too toxic for healthy subjects (some cancer medications, for instance), phase 1 trials are performed in patients with diseases to test these parameters. Phase 2 trials The goal of phase 2 trials is to grasp additional understanding of the studied drug's safety and efficacy. It also determines the appropriate dose to be administered to deliver the desired treatment effect while minimizing the safety risk of future research subjects. This usually requires more than 100 patients to demonstrate relevant results, although the actual number of subjects varies widely based on the disease under study. Thus, multiple clinics are utilized to recruit subjects with the disease under study to IMK VARKALA Page 9

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sufficiently enrol the study (ies) in a reasonable period of time. Phase 3 trials Multiple phase 2 studies are often required to define the appropriate patient population to study during phase 3. Once the drug is deemed a potentially safe and effective candidate in Phase 2, it is then studied in Phase 3 trials. This phase often exposes more than 1000 research subjects with the disease, and is usually performed at many clinics (sometimes well over 100) to enroll the trial (or trials). There is a focus on the effectiveness of the study drug in a variety of demographic and socioeconomic subjects with variants of the disease under study. A comparison is usually made with standard drugs available on the market. It is imperative that the drug is shown to be effective and safe in this phase. When phase 3 trials are completed (as well as the data demonstrating safety and efficacy of the study drug), a New Drug Application (NDA) containing all manufacturing, pre-clinical, and clinical data is filed with the FDA for review. If deemed safe and effective, the FDA grants approval of the NDA, which then allows the company to market the product. This approval usually comes with strict requirements for the company to conduct additional studies to keep the NDA active (usually involving pediatric trials and additional safety trials). Phase 4 trials In phase 4, the aim is to further characterize the safety of the drug through the identification of unknown adverse reactions and to potentially research new therapeutic indications. Companies often use this phase to gain exposure to different physicians and clinics, which aids in the marketing of their product. The entire process of a drug from lab to market may take approximately 12 to 18 years (but not always), costing billions of dollars. Further trials Clinical research continues throughout the lifetime of the test article to include post marketing surveillance where a periodic 'progress report' is submitted to the regulatory authorities once every 2 years after the test article is released into the market, and such as pharmacovigilance where the safety of marketed drugs, biologics IMK VARKALA Page 10

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or medical devices are monitored.

The focus of clinical research is wide enough to include important items such as data management, medical writing, regulatory consultation, and biostatistics. The clinical trials are regulated by country specific Health Regulatory Agencies such as the Food and Drug Administration (FDA) in the U.S. and the European Medicines Agency (EMEA) in the European Union.

2.1.1CLINICAL RESEARCH METHODS Statistics in medical research Univariate statistics - continuous data Univariate statistics - discrete data Basics of correlation and regression Principles of multivariate and logistic regression Survival analysis Multivariate analysis of clinical data; introduction into modern methods of analysis of huge data.

2.1.2 CLINICAL RESEARCH INDUSTRY

Clinical research is the bridge between the lab and the market for new drugs, and that market is expanding rapidly. Spending in the US for prescription drugs increased by 12 percent a year during the 1990s, and has continued to increase by 8 percent a year since 2000. The Kaiser Family Foundation projects that spending will continue to increase by around 8 percent a year over the next decade. 1 The biggest factor driving the increase in spending is utilization. The average number of retail prescriptions per capita increased from 7.9 in 1994 to 12.3 in 2005. There are a number of reasons for this increase. First, the incidence and prevalence of many chronic conditions -- such IMK VARKALA Page 11

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as asthma, diabetes, high cholesterol and arthritis -- has increased in recent years, in part because the population is aging but also, in some cases, because it is less healthy. There are many new drugs for these conditions, which must be taken daily over many months or years (and sometimes for life), increasing the volume of prescriptions. Second, doctors are diagnosing and treating these chronic illnesses at a higher rate than in the past, and they are using a wider variety of drugs to do so. Third, newly-approved medicines are being more heavily marketed to both doctors and consumers. Fourth, many brand name drug companies have been extending the franchise of their branded blockbuster drugs by spinning off new formulations or versions of them. 3 And finally, the introduction of Medicare Part D drug coverage has significantly increased utilization. In addition, there is an expanding market for new biologic drugs. Prior to decoding the human DNA, only about 500 disease-causing functions in cells or viruses had been found. But with the growing understanding of how DNA works, the number of potential new drugs could grow into the thousands.4 A decade ago, 14 biotech firms in the US marketed a total of 22 products. In 2003, 66 companies marketed 187 products, including 12 blockbusters that reap over a billion dollars a year. Today, there are 230 medicines on the market developed using biotech techniques. An estimated 50 more in late-stage clinical trials are expected to win FDA approval, and another 400 products are in the pipeline going through Phase III trials.5 Four out of five drugs currently in development are founded on biotech discoveries or employ biotech tools. Research and development of new drugs is also being fueled by public investment in bio-defense and stem-cell research. The federal BioShield law provides $5.6 billion over the next 10 years to develop products critical to defending against bioterrorism. In California, voters passed an initiative to fund $3 billion in stem cell research over the next 10 years, and Connecticut followed suit with a similar $1 billion initiative. These public funds will spur research that is likely to spin off many new commercial applications. IMK VARKALA Page 12

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2.1.3 Streamlining Drug Development

At the same time that the market for new drugs has been expanding, there has been increasing pressure to reduce the cost of prescription drugs. The price of prescription drugs increased an average of 8.3 percent a year over the past decade, more than triple the annual rate of inflation.7 Health plans have responded by excluding certain drugs from coverage, requiring generic drugs when available, and increasing co-payments. Consumers have responded by requesting cheaper drugs from their physicians, using the internet to find lower prices, using over-the counter. Rather than prescription drugs, buying in bulk and by mail-order. One way drug companies have responded to mounting cost pressures is by trying to streamline the development process for new drugs. In the early 1990s, the industry focused on reducing delays in the FDAs approval process. Following enactment of the Prescription Drug User Fee Act (PDUFA) in 1992, the FDA

Significantly increased the number of staff devoted to new drug review, nearly doubling the number of FTEs between 1992 and 2003.8 However, due to the growing number of new drugs requiring review, of applications for new uses for existing drugs, and of appeals of holds put on clinical trials, the FDA workload increased substantially. As a result, after clearing its backlog of new drug applications between 1996 and 1998, the pace of FDA approvals for new drugs fell again through 2004. At the same time that delays have crept back into the approval process, public concern about patient safety has prompted more extensive clinical trials to demonstrate the safety of new products. The FDA now requires larger patient populations and more trials in each study phase to better monitor adverse effects. Some estimates suggest that clinical trials today require 2-3 times as many

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participants as they did 10 years ago. In addition, the average length of a clinical trial has increased by 21 percent since 1999. And it will undoubtedly increase even further in the aftermath of the Vioxx recall, as drug companies are now required to track and report more extensively on Phase 4 trials (once the product has hit the market).

2.1.4 Outsourcing Clinical Research

This creates a real dilemma for drug companies. Under pressure to reduce drug prices, they are intensively searching for efficiencies in their product development process. Meanwhile, the number of new drugs entering clinical testing has increased by 52 percent since 2000. The combination of more drugs in the pipeline and the need to test them more extensively is straining the organizational capacity of companies sponsoring those drugs. This is particularly true in biotech companies, which tend to be small and lack the internal resources to conduct clinical research on their own. As a result, more and more drug companies are outsourcing their clinical research to contract research organizations (CROs). The Tufts Center for the Study of Drug Development estimates that drug companies have been increasing their spending. On contract clinical research services by 15 percent a year since 2001. As a result ,the number of CROs has grown by 65 percent since 2001.13 And headcount at CROs has grown by 6 percent a year since 2001, while headcount at the drug companies has remained flat. Studies show that CROs are able to complete drug development faster than the drug companies themselves, without sacrificing data quality. Even though clinical research conducted by CROs tend to involve larger numbers of investigative sites and study volunteers, the projects are typically completed closer to the projected completion date than when drug companies conduct the research themselves. This can make a huge difference financially, since taking a month off development time can generate IMK VARKALA Page 14

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an additional $40 million in sales for the average drug. During the 1990s, more than half of all US clinical trials missed their deadlines by at least a month. As a result, there is a trend toward outsourcing full-service clinical research projects, and even entire drug development programs, to CROs. This is particularly true in the biotech sector, where outsourcing has increased dramatically.

2.1.5 Moving South and Going Global

Another response to cost pressures has been to shift clinical research to lower-cost areas. During the past decade, there has been a migration of FDA-approved principal investigators from the Northeast to the South within the US. Between 1994 and 2004, the proportion of principal investigators working in the South grew by 20 percent (to nearly 40 percent of the nations total), while the proportion working in the Northeast declined from 23 percent to 19 percent of the nations total. There has also been a significant increase in the scope of clinical research being conducted outside the US. During the 1990s, the number of foreign principal investigators seeking FDA approval increased sixteen-fold. By 2001, roughly 27 percent of new drug applications to the FDA included foreign test results.20 And by 2004, around 21 percent of the spending on clinical trials was on studies conducted outside the US. There are several factors driving this trend. The first factor is cost. Companies can reduce their costs by 10-50 percent by conducting clinical trials outside the US. The second is the ability to find test subjects. It is much easier to find the 3,000- 4,000 patients needed to complete all phases of clinical testing overseas, because the lack of insurance, the high cost of medicines, and the abundance of diseases in need of treatment make recruitment much easier. The failure to find enough patients accounted for 85-90 percent of the days lost during clinical trials in the US during the 1990s.

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Also, clinical researchers claim that Americans often makepoor test subjects, because they already take so many medications that its difficult to isolate the effects of the drug being studied. And finally, there is much less government bureaucracy to deal with outside the US, since many of the FDAs regulations stop at the border. The ability to operate on a global scale is becoming a must for CROs. By 2002, onethird of US-based CROs had opened a foreign office and increased their recruitment of foreign test subjects. Industry observers expect that this trend will continue, and that mid-sized and large CROs with global operations will have a competitive advantage.

Going Paperless
In addition to outsourcing and off-shoring clinical trials, another way to cut the cost of new drug development is to adopt new technologies to manage the huge amounts of patient information involved. A typical new drug application to the FDA involves hundreds of thousands of paper records, which often arrive by the truckload. In 2003, an estimated 95 percent of clinical trials relied on paper records. But there has been a dramatic increase in the adoption of electronic records over the past several years, as electronic records have proven effective in reducing the costs of development and data management in clinical research. This trend parallels the adoption of electronic health records by hospitals and physician practices, which holds significant promise for clinical research. In large organizations -- such as the Veterans Health Administration, Kaiser Permanente, and the Geisinger Health System clinical data captured in electronic health records are now being used to answer questions about the safety, effectiveness, and costs of new treatments. Similar databases for research purposes are being built by the National Cancer Institute and the HMO Research Network, the Centers for Disease Control and Prevention, the American Medical Group Association, and the Centers for Medicaid and Medicare Services.

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These computer-searchable databases, which include clinical information on tens of millions of patients, can help fill some of the gaps in the current clinical research. Most clinical trials focus on younger adults in carefully controlled circumstances. Groups like seniors, the disabled, children, minorities, and patients with multiple health problems are frequently under-represented in these trials, even though these groups account for the bulk of health care spending in the US. Information on how these groups respond to drug treatments under normal conditions could shed new light on the effectiveness of different therapies, reducing the need to track selected patients for years to get the same information. These databases could also dramatically reduce the amount of time and effort required to recruit participants into clinical trials. Currently, tens of thousands of people need to be screened for a clinical trial to get the 4,000 or so needed to conduct the trial. Thats because only a fraction turn out to be medically eligible. Searching large databases could identify medically eligible candidates in a fraction of the time it currently takes. This is particularly important when it comes to biotech drugs, which are usually targeted to specific population groups. It is enormously time consuming andexpensive to identify the subpopulations for whom these drugs are targeted, using the normal screening process. But, large computer-searchable databases could accomplish this task in weeks or even days. A recent study suggests that around 24 percent of physicians currently use some form of electronic health record, with the adoption rate much higher in larger physician practices than in smaller practices. Only about 5 percent of hospitals have similar electronic record systems currently in place. But there is a concerted national effort to pick up the pace, given the widely held view that the adoption of information technologies is key to curbing the rapid rise of health care costs in the US.

Implications
Taken together, these trends suggest that the regions in the US that are best positioned to expand their clinical research industry are in the Southern states, and have a strong IMK VARKALA Page 17

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or emerging biotech sector, a large patient population and/or contract research organizations with global reach, and are ahead of the curve in adopting electronic health records and/or have the ability to tap into the large national databases that are being built.

2.2 National level

India with its strengths such as; efficient and well qualified medical community, a

huge patient and disease pool, representation of 15 per cent of the global population by Indians, English as a primary language of education, large and rapidly growing health care sector and Governments commitment to align with GATT/TRIPS/WTO; will all play a significant role in ensuring that India will evolve as a preferred destination for contract research activities Background: The cost of drug development has soared during the past ten years compelling pharmaceutical and biotechnology companies to look for new, smarter ways of conducting clinical research. Driven by mounting market pressures, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development. By decreasing their in-house facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and biotechnology companies are reshaping the drug development services industry. This industry has evolved from providing limited clinical trial services in the 1970s to a full-service industry that today encompasses the entire drug development process, including preclinical evaluations, study design, clinical trial management, data collection, biostatistical analysis, and completing product regulatory requirements. CROs and SMOs It is imperative that pharmaceutical and biotechnology companies pass their product through the testing and regulatory process in a rapid, cost-effective manner. To accomplish this goal, pharmaceutical companies are relying on outsourcing strategies to provide the services that can bring their therapeutics to market faster. Contract research organizations (CROs) were first organized as outsourcing service companies that provided only clinical trial management. IMK VARKALA Page 18

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Today, many CROs have expanded their scope of services to provide comprehensive management of the complex drug trial processes for their client companies, as well as providing access to vast areas of expertise, which may not exist in the clients internal organization. In 2001, in the United States, CROs received an estimated 60% of the clinical research outsourced from pharmaceutical companies. The combination of the growing trend by pharmaceutical companies to outsource a wider range of services, and the need to pass products through the testing and regulatory process in a rapid, costeffective manner, has lead to skyrocketing growth of the CRO market. Over the past few years, CROs have received the lion's share of outsourced clinical research revenue. The CRO market grew from $1 billion in 1992 to more than $8 billion in 2002. Typically, large CROs compete on the basis of medical and scientific expertise in specific therapeutic areas; the ability to manage large-scale trials on a global basis with strategically located facilities; by providing medical database management capabilities; providing statistical and regulatory services; the proven ability to recruit principal investigators, and patients into studies; and the ability to integrate information technology with systems to improve the efficiency of contract research. The efficiency of a clinical trial can be greatly compromised by the challenge of efficiently enrolling patients, securing clinical trial sites, and collecting data. Pressure to expedite clinical trials, while reducing the cost of the trials, has led to yet another new, rapidly evolving business: Site Management Organizations (SMOs). SMOs are quickly consolidating the fragmented clinical investigator market into wellmanaged networks of sophisticated clinical research sites. SMOs are management service companies that organize and manage multi-site clinical trials through contractual relationships with site owners, or direct ownership of the sites. Analysts estimate that the SMO industry will grow at a rate of about 43% per year over the next few years. Although SMOs represent competitors of CROs, they are also often IMK VARKALA Page 19

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subcontractors to them. It is estimated that as many as half of an SMOs clients are CROs. Outsourcing in drug development-Global Outlook The R&D budget accounts to about 15 per cent of total global pharmaceutical sales. The global pharmaceutical R&D expenditure was $ 47 bn in 2002 and it is estimated that pharma & Biopharma R&D expenditure put together in 2003 will be $ 60 bn. The major contributors are US-$36 bn, EU-$ 20 bn, Japan-$ 4 bn and rest of the world is just beginning its research programme which could account for about $ 2 bn by 2005. The R&D budget is allocated in the following manner in terms of various activities:

Non-clinical - 19.5 per cent, Discovery - 26.9 per cent, Clinical - 38.2 per cent (of which phase I - 6.7 per cent, phase II & III- 25.5 per cent & phase IV 6.0 per cent). Regulatory - 4.1 per cent and Others - 11.3 per cent. A survey on global CRO market size conducted by Technomark Consulting Services, London in 2002 estimates clinical research related activities at $ 5.56 bn (60 per cent) and pre-clinical toxicology and analytical research activities at $ 3.79 bn (40 per cent), aggregating to a grand total of $ 9.39 bn. In other words, it is almost equal to 2.5 times the total Indian pharma industry or 3 times the gross national product of Zambia or 1/3rd the size of present global biopharmaceutical industry. Out of the $ 47 bn pharma R&D budget, $ 9.39 bn was out sourced in 2002. Going forward, the R&D budget has been incremented by 5 per cent year on year basis. Expected outsourced market share to grow by 2.5 per cent year on year (Table 1). Year R&D Budget in $ bn CRO market in $ bn % Outsourced 2001 45 8 17.5 2002 47 9.39 20 2003 49.35 11.10 22.5 2004 51.82 12.95 25.0 2005 54.41 14.96 27.5

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This is in line with the earlier growth average in this industry.Therefore it is estimated that the CRO market size would increase to a whopping $ 15 bn by 2005 Outsourcing in drug development-Indian Outlook Given the Indian strengths like well qualified medical community; mature, supportive and strong pharma industry; representation of 15 per cent of the global population by Indians, for whom to a degree the drug is developed and therefore needs to be subjected in the clinical trails; further, a 200 mn middle class concentrated in urban India; english as a primary language of education; large and fast growing health care sector and communication and governments commitment to alignment with GATT/TRIPS/WTO could play a significant role in ensuring that India captures a meaningful share in the outsourcing pie. The clinical trials that have been conducted in India till date have gone well. For majority of the studies, patient enrollment is a key advantage. This helps compress the development timeline and data quality is excellent. Numerous audits in India are a testimony to level of quality. And data from clinical study in India have been successfully filled with international regulatory agencies. The potential realized at present is a fraction of the possible in India. Consistent with WTO guidelines effective from 2005, India will also offer 10-year tax concessions on revenue to companies making Research & Development (R&D) investments here. These incentives are expected to substantially increase R&D activities of both multinational and domestic biopharmaceutical companies. Analysts are projecting that total Clinical Research spending in India will increase by more than 30% annually through 2010. The Clinical Research industry in India has grown from Rs 20 crores to Rs 100 crores in the last three years. As per a recent McKinsey report, it is expected to touch Rs 5,000 crores by 2010 and will employ 50,000 people in the next five years. It is a prediction of the Government of India that it will be more than Rs.10,000 Crore business in coming five years. A preliminary survey made by Genesis Management Consultancy Services shows that on an average 50 prominent contract research organisations exist in India providing their services in drug discovery, clinical trials, bioinformatics and additionally it is estimated that about 30 more small size CROs exit. IMK VARKALA Page 21

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In the clinical trials segment alone about 15 prominent players exist of which few are MNCs, some have international collaboration and the rest are actively looking for one which will enable them to participate in the global studies. Therefore, though the industry is nascent and minuscule, it is poised to grow rapidly. 2.3 COMPETITORS OF THE COMPANY The major competitor of KREARA SOLUTIONS is a Multi National Company named

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Krear

CHAPTER III COMPANY PROFILE

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3.1 COMPANY PROFILE
The primary job function of KREARA SOLUTIONS is to create valuable service to their customers. An integral part of their genetic structure is to create long-lasting customer partnerships and working with the customers of the company to identify their needs and provide solutions that support their success. The concept of solutions being driven to address specific customer challenges has been with Kreara since their inception. As the company grew from a small team of two people to a much larger group, they never let go of their focus to treat each of companys client as our only client . Ever since the companys inception in April 2004, company have a track record of treating each of their client from the life sciences industry with respect and providing them with three value additions; Cost Effectiveness, Quality and Timeliness. Kreara heavily focus its services on the Clinical Research and life sciences industry and provide data management, software and statistical services of the companys customers.

3.2 HISTORY OF THE COMPANY

The name KREARA word derived from the Spanish verb `CREAR which means ``TO CREATE. The orgaisation was established in April 2004 as a private limited company with the intention of providing quality services for the clinical research, life sciences and financial markets. Ever since their inception the company have grown into one of the most trusted partner for some of the life sciences companies across the globe. The company employs a good mix of statisticians, software engineers and clinical data managers.

Kreara has grown into a leading Clinical Research Organization that specializes in providing data management, statistical and software solutions for the process of clinical drug development. In the due course that the company have worked with

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clients from Europe, USA and Japan. And they have also developed a state of the art training program that provides them with industry.

3.2.1 CORE VALUE OF THE COMPANY

Trained Resources, Quality, Timeliness and Cost Effectiveness are four core values that the company thrive to deliver. Their customers from Europe and USA have experienced a cost saving of more than 40% by working with the company. And they have successfully implemented an extended organisation methodology into their clinical and life science practices which ensures that the risks related to the cost and time will be mitigated in a proper fashion. The key to the extended organization is a so-called program office, where the client company and the outsourcing provider collaborate with the help of a finely calibrated monitoring system. The company have a full fledged training program that is designed with the emphasis of data quality and timely delivery of services. Cross-functional training is employed to satiate employees desire to learn and acquire new skills. It also equips employees to handle different jobs with relative ease. The customer benefits by developing a talent pool that can handle a variety of jobs. It enjoys greater flexibility in assigning tasks and balancing the workload of employees. This in turn helps Kreara to stay on target and meet customer demands better.

3.3 STRATEGIC INTENT

3.3.1 MISSION

The company mission is to become the Number 1 CRO in the country providing supplementary services for clinical trials and ultimately help our clients to make affordable and quality health care to the masses a reality.

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OBJECTIVES OF KREARA SOLUTIONS To provide quality service and products to consumers at reasonable prices. To make available service of commensurate to demand. Consumer protection and satisfaction. Safeguarding of customers interests.

COMPANY DETAILS The kreara solutions is situated at tecknopark trivandrum. And the headoffice also Situated in technopark , trivandrum.The company doesnt have any other branches or extension centres. OFFICIAL ADDRESS Kreara solutions Pvt Ltd. T4 , 7th floor , Thejaswini building Tecnopark campus , Trivandrum Kerala , India 695581 PHONE:- 04712527640 Web :- www.kreara.com E-Mail :- bindu ashok @ kreara.com

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OFFICIAL LOGO OF KREARA

EXPANSION OF KREARA
CUBE COOL GREEN FREEDOM BLUE AGGRESSIVE RED - SIGNIFICANCE - YOUTHFULNESS , QUALITY - IDEAS , CREAIVITY - ACTION

EMPLOYEES

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Number of employees working in Kreara Solutions. 31 employees are working in this company.

DEPARTMENTS SAS IT MARKETING SOFTWARE HR

EMPLOYEES 13 1 1 14 2 TABLE 3.8 EMPLOYEES

SLOGAN OF THE COMPANY

"Our assets are our employees

SOME OF KREARAS PARTNER CROs IS LISTED :-

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3.4 PRODUCT PROFILE OF KREARA SOLUTIONS Over the existence of the past several years, Kreara has built innovative products that enable cutting-edge analysis, relationship building, modeling and accurate predicting, building and deploying of systems-biology models etc. Their products are very userfriendly and adept at dealing with complexity. They help users conduct virtual experiments and use the results in an intuitive manner. Their products include an electronic CRF platform, an electronic randomization frame work, an artificial neural network for cancer prognosis prediction, and a SAS programming quality control framework. EZECRF EZECRF is an e-CRF application that allows capture of clinical trial information in a rapid manner using laptops or palmtops and directly populates a central database without the use of intermediate paper CRF. The EZECRF application comprises of computer forms corresponding to each page of the CRF using which, the investigator can enter data directly into the database at the back end. This approach helps reduce the time spent on transfer of paper CRFs to the data management center and also the entry of the data into the database. This further helps do away with errors which occur during the time of data entry. Kreara has a team of well trained software professionals who are capable of designing and implementing customized CFR Part 11 compliant EZECRF for any clinical study as per client requirement in an efficient and timely manner. The ability to understand and guide technology, together with the awareness of the clients goals and objectives, makes Kreara a valuable resource throughout the EZECRF implementation process. A manual describing the installation, maintenance and use of the EZECRF is also

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provided to the clients as a guidance document in addition to training on use of the application. EZEQC Sopanam is an in-house developed web based tracking application with in-built audit trails which helps follow the progress of SAS programming and quality checking tasks. This application is used to assign team members to a particular project and also

to assign each SAS program, to be developed as part of the deliverables, to statisticians, SAS programmers and quality checking personnel. The application has a provision for team members to fill in the status of the SAS programming tasks assigned to them. This application is used by the project managers/leaders and the client representative to check the status of the SAS programming tasks at any time by generating reports automatically.

The user friendly interface can be set up separately for different clients, thereby ensuring information security for each client. The tracking system enables easy assignment options, status log-in and also helps concerned personnel follow up progress of projects easily.

e-Randomization Randomization is a process of allocating subjects to different interventions (treatments or conditions). The randomization procedure in a randomized controlled trial (RCT) gives each subject a predefined chance of being assigned to any of the intervention groups eliminating any bias involved and balancing the confounding factors betTheyen treatment groups.

Kreara has a team of well qualified statisticians who have sound knowledge in randomization techniques like simple randomization, permuted block randomization and adaptive randomization. The randomization algorithm for any specific project is

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developed based on the study requirements by taking into consideration various prognostic factors. A study specific web based randomization application is developed using ASP.Net or VB.Net based on the algorithm, taking into consideration all the statistical requirements. The database for the application is designed using mySQL. This web based application called EZRAND is developed as part of the data management services provided by Kreara. As per client requirements, Kreara develops EZRAND

which can either be implemented at the client site or can be deployed at Kreara which acts as a randomization centre with 24*7 on call support.

ANCANZ This project proposes to implement a generic framework that will implement an ANN for cancer prediction and prognosis. The model will then be programmed using VHDL on an FPGA chip which will then be embedded into a palm device which will be used by the clinician for personalised decision making. Claimed advantages of this product include: Ease of optimisation, resulting in cost-effective and flexible non-linear modelling of large data sets. Accuracy for predictive inference with potential to support clinical decision making. These models can make knowledge dissemination easier by providing explanation, for instance, using rule extraction or sensitivity analysis

KREARAS QUALITY POLICY

Kreara solution private limited recognizes that the management of quality, health, safety and environment are an integral part of its operation. The company views its commitment towards customer satisfaction as a primary responsibility. The company IMK VARKALA Page 31

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quality policy calls for continual improvement in the companys quality management activities and for the business to be conduced in the compliance with agreed industry guidliness for quality assurance as exemplified by the agreements between the customers and their regulating bodies world wide. Krearas Culture Kreara promote an open culture, encouraging feedback, and we respond actively to transform it into action. KREARA believe that excellence is not a destination but a journey of continuous improvement. They enthusiastic, goal-oriented professionals provide best business solutions and technical advice. At Kreara we strive to build a diverse, effective work force through equal opportunity employment with a

transparent work environment. 360-degree appraisal system provides feedback at all levels; from peers, subordinates and superiors, which help in the overall development. Kreara places strong emphasis on initiative, leadership, and responsibility. If you join Kreara you will be constantly challenged, encouraged to think independently and try new ideas while taking an active role in the decision-making process. Kreara believe that the more active your involvement, the more rewarding your work and the more valuable your contributions. Their most obvious and enduring strength is the quality of our team, working in one of the most cooperative and friendly environments you will ever experience. and we go beyond expectation to provide employees with many benefits. At every step of success there is a special incentives and equal opportunities to grow with Kreara. Its a great place to work, and their standards are high. Krearas People "Our assets are our employees At a time when organizations are debating the strategic importance of their human resources, Kreara a software services organization, includes its human resources on its Balance Sheet to affirm their asset value. "Investors examine financial and non-financial parameters that determine long-term IMK VARKALA Page 32

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success of a company. Human resources at Kreara represent the collective expertise, innovation, leadership, entrepreneurial and managerial skills. Their representation is based on the belief that intangible assets provide a tool to our investors for evaluating market-worthiness of Kreara". They eliminate the us and them between management and non-management and replace it with were all in this together companys success; an inclusive environment has been created. They are proud to announce that many of our employees are with them since past years as we provided them exciting careers and even they want a company who trust them.

CHAPTER 4 ORGANISATION STRUCTURE

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4. 1 ROLE OF ORGANISATION STRUCTURE: An organizational structure is mainly a hierarchial concept of subordination of entities that collaborate and contribute to serve one common aim. It is a frame work within which the managers decision making behavior takes place. An organization can be structured in many different ways and styles, depending on their objectives and ambience. The structure of an organization will determine the modes in which it operates and performs. Organizational structure allows the allocation of responsibilities for different functions and processes to different entities such as he branch, department, workgroup and individual. It establishes a well patterned relationship among the components of the organization. An organizational structure is capable of serving many functions at the same time but cannot serve all functions equally well over unlimited time. It is important for managers to determine the outcomes desired from organization structure, and to match the organization with changing needs. While talking about KREARA, its structure starts with two CEOs followed by three directors and the company having five director board including the CEOs. IMK VARKALA Page 34

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4.1.1MANAGERIAL LEVEL EMPLOYEES SAS SOFTWARE HR IT MARKETING

TABLE 4.1.1 MANAGERIAL LEVEL OF EMPLOYEES

4.1.2 HEAD OF THE DEPARTMENT

SAS SREEDEVIMENON

SOFTWARE

KRISHNAKUMAR

HR

BINDU ASHOK KRISHNAN

IT

KIRAN CHANDRAN

MARKETIN G

NISHANTH NASEEM

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TABLE 4.1.2. HEAD OF THE DEPARTMENT

4.2 ORGANISATIONAL STRUCTURE

CEO

DIRECTOR

OPERATIONS

PROJECTS

HR ADMINITRATION MARKETING

QUALITY ASSURANCE

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SOFTWARE SERVICE

CHART 4.2 ORGANISATION CHART

4.2.1 WORKING ENVIRONMENT WITH KREARA

The organisation is situated in Tecknopark Trivandrum and the government and the park authority are providing world class working environment and infrastructure facilities. The companys in the park and most of the companies are IT companies . The office has the look of a modern corporate office. And in the office company providing all type of facilites . Allow the employees work to properly and efficientily. The organization is also concerned about the safety and health of the employees. And also providing all type of benefits and protection by the labour act of India . Kreara is looking for hard core professional who is committed and have a passion to implement innovative solutions that helps to discover a new business world. Kreara provides the opportunities to explore your potential, continuous growth, and challenges in the areas of Clinical research, Business Intelligence, Financial Services IMK VARKALA Page 37

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and Market Research. They offers you a challenging and inspiring career where you will enjoy the team spirit, quality of life which will enable you to deliver the quality result and a keen desire to grow professionally.

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CHAPTER V ANALYSIS OBJECTIVE WISE

FUNCTIONAL AREAS

SAS department is one of the most important departments in KREARA is under the control of the managing director.

KREARA is comprised of different functional areas and they can be classified into:

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MARKETING DEPARTMENT SOFTWARE DEPARTMENT IT DEPARTMENT HUMAN RESOURCE DEPARTMENT

5.1 SAS DEPARTMENT

Kreara has a skilled team of certified programmers with extensive exposure and experience in various modules of SAS. The blend of statisticians and SAS programmers in the team ensures effective and competent use of SAS for statistical analysis of data. The expertise of the team in the use of SAS for data management and reporting activities further ensures that appropriate data is utilized and results are reported effectively. The proficiency of the programmers in the development and application of SAS macros further enhances the quality and timeliness of the services.

Ms.Prajitha Nair is the Project Manager of SAS Programming in Kreara Solutions.

The common tasks performed at Kreara using SAS are Data retrieval management, and mining

Basic data analysis Statistical analysis Report writing and graphics

The team of programmers keeps pace with the latest advancements of the software by being part of discussion forums, participating in conferences and training programs. Internal trainings and knowledge transfer sessions further help enhance the programming capabilities of the team members.

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5.1.1 Clinical Data Management Kreara provides a complete continuum of data management solutions to pharmaceutical, biotechnology and medical device industries worldwide. The data management group at Kreara develops a comprehensive data management plan detailing the requirements and actions, based on client input. The data management team undergoes brain storming discussions within the team and with the client to clarify the project requirements. The data management team at Kreara reflects a blend of internal efficiency, flexibility and experience resulting in a customized service that demonstrates commitment to meeting the timelines and project goals set by the clients. Further, Kreara data management group works to meet high-level global standards. A set of standard SOPs related to data management ensure that the data management tasks are performed in a consistent manner throughout the company. Services provided by Kreara under the Clinical Data Management include: Preparation of the Data Management Plan Development and set up of the e-Randomization application Acting as the randomization center Maintenance of the blind for the study CRF design and development Preparation and set up of the e-CRF application

Preparation of the Data Definition Table Design and set up of the Database tailored to CRF specification CRF scanning and Data Entry using a Data Entry application with built in validation checks

Data Verification using single or double data entry methods Data Validation

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Execution of the Blind Review Handling of external data like laboratory ranges and pharmacokinetic data MedDRA coding for Adverse Events Coding for Concomitant Medication Serious Adverse Event Reconciliation against client safety databases Raw Data Listings and tables available in formats including Excel and SAS Data Exports into several formats, including SAS, SPSS and Oracle Migration of data into CDISC standards

5.1.2 Bio Statistics Biostatistics or biometrics is the application of statistics to health related studies. Biostatistics finds its application in the fields of medicine, biological and clinical studies. This science includes the design of studies, collection, summarization, analysis and interpretation of data and also the inference from results. The services provided by Kreara in this area are Sample size determination Providing input to the statistical section of the study protocol Preparation of the Statistical Analysis Plan based on the study protocol Designing the tables and listing templates Spearheading the analysis of the data Interpretation of the results obtained from the analysis Preparation of the integrated final report

Kreara has a team of well qualified statisticians with a combined experience of more than 10 years in providing biometrical services to clinical trials pertaining to various therapeutic areas. The team is encouraged to take active part in internal and external training sessions and conferences to remain updated with the latest trends in statistics. IMK VARKALA Page 42

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The team structure of statisticians includes a Project Statistician who leads a team of statisticians to accomplish the timelines effectively and efficiently. Brain storming sessions are held on a periodic basis to ensure that the statistical methodologies applied for the particular study are apt and effective. Regular status meetings within the team and with the client are held to discuss issues and also to keep track of the project progress.

5.1.3 Efficacy / Safety Analysis Efficacy and safety analysis form the most important part of data analysis pertaining to any clinical trial study. Efficacy analysis involves statistical analysis to determine the effectiveness of the administered medication while safety analysis involves determination of the safety of the medication. Kreara has extensive experience in carrying out efficacy and safety analysis for studies in various therapeutic areas. As part of the efficacy analysis, the services provided at Kreara are performing the statistical analysis and presenting related outputs. As part of the safety analysis, Krearas services include development of tables related to safety data like Adverse Events and Laboratory Data. SAS macros are developed for outputs related to safety analysis thereby ensuring quality and timeliness of the services. The Statisticians, SAS programmers and quality personnel at Kreara work as a team to ensure that the outputs provided as part of the above analysis meet the clients standard and timeline requirements.

5.1.4 Medical Writing Medical writing refers to scientific documentation associated with clinical research and medical industry work. Kreara has well qualified and experienced medical writers with in-depth knowledge and outstanding reporting skills. The expert team of medical writers facilitates quality based documentation in compliance with ICH guidelines and the FDA/EMEA regulatory requirements. With its expertise, Kreara ensures providing well-defined documentation within the tentative timelines.

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The various services provided by Kreara are Protocol Writing Statistical Analysis Plan Statistical Report Clinical Study Report

5.1.5 CDISC Migration Study Data Tabulation Model (SDTM) and Analysis data Model (ADaM) are two standard structures set by the Clinical Data Interchange Standards Consortium (CDISC). These standard structures are to be adhered to during data submission of human clinical studies to regulatory authorities like the United States Food and Drug Administration (FDA). This transformation of raw data of a clinical study to CDISC standards is referred to as CDISC Migration. Kreara has an expert team of professionals with sound knowledge in these standard structures, corresponding implementation guides, CDISC terminologies and the related ICH guidelines. The team keeps track of the latest developments and changes by subscribing to newsletters, actively participating in discussion forums and attending conferences. As part of CDISC migration, the team develops the specification document and the annotated Case Report Form (CRF), which present the mapping of variables from raw database to the CDISC standards. The team also develops SAS programs which actually map the data from the raw structure to the standard structure and the SAS datasets containing data as per CDISC standards.

5.1.6 Bio Equivalence Studies Bioequivalence studies are designed to examine whether the systemic bioavailability of a test product and those of the reference product differ significantly. Bioavailability captures how fast the drug enters the systemic circulation (rate of absorption) and how much of the nominal strength enters the body (extent of absorption). Two pharmaceutical products are considered to be bioequivalent if their bioavailabilities, IMK VARKALA Page 44

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from the same molar dose, are so similar that they are unlikely to produce clinically relevant differences in therapeutic and/or adverse events. Kreara has extensive experience in performing statistical analysis for Bioequivalence studies. The proficiency of SAS programmers further enhances the computation and presentation of results in an appropriate manner. The services provided by Kreara in this area are Preparing Statistical Analysis Plan Computation of the Pharmacokinetic parameters using SAS Statistical analysis Statistical reporting of descriptive and Graphical summaries Integrated Final Report

Kreara helps clients improve the business outcomes that cope with todays fast paced environment by switching to the predict and act mode using predictive analytics and thereby provide confidence to pursue new market opportunities. Kreara applies appropriate statistical techniques for prediction using SAS to give solutions that work best for the clients. The statistical expertise of Kreara is capable of conducting a wide range of statistical analyses including regression techniques, time series modeling and survival analysis. The statisticians at Kreara have vast experience in applying predictive analysis in various scenarios and also in presenting reports that have helped clients reap major benefits in business. Here again the blend of statisticians and SAS professionals helps selection and application of the most appropriate statistical

technique to any situation. The statisticians keep pace with the latest developments in this area through discussion forums, conferences and association with academic institutions.

5.2 MARKETING DEPARTMENT

Understanding markets and customers is the bedrock on which business planning and strategy is built. Without knowing customer needs or understanding demand, a IMK VARKALA Page 45

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business will be under constant threat from competitors and may be failing to extract the maximum value from the market. Thus the success behind any business is to understand the market and satisfy the customer needs by utilizing timely and relevant market information. Market Research is a systematic process of collection and analysis of data from a current or prospective target market, which enables identify trends in the market that affect sales and profit. Kreara offers services related to market research from the very inception of the idea of conducting a study to the final interpretation of the results. The various services offered in this area are Questionnaire preparation Sample size determination Sampling design determination Target group identification Data collection Data entry Designing and implementing the analysis Interpretation and presentation of results Building inferences from the results

Kreara, with its team of experienced statisticians ensures proficient services in these areas. Great effort is taken to make sure that the projects are implemented and completed as per requirements and timelines set by the client. 5.2.1 Data Mining

In the current business world Data Mining is essential to predict future trends, for the business to stand successful and proactive. Kreara follows the latest data pattern extraction techniques that help enterprises focus on the most important information in their data warehouses. The procedure starts with Data analysis where the quality of data is checked. Most likely patterns are identified through data mining and presented in graph or table formats. Verification and validation of patterns are done to identify hidden predictive information and Identify key areas where the predictive models are IMK VARKALA Page 46

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minimal and provide timely ROI. Their process guarantees confidentiality and privacy obligations. Timely processing practices followed in Kreara allows users to automatically experiment with more models to understand complex data in turn yield improved predictions. Features Analyse data by application software Data categorization Identify patterns and trends Knowledge driven decisions Choice modelling for more precise predictions

The practices followed are updated with continuous innovations to identify out of scope scenarios that provide better and more intelligent predictions driving down the cost of the customer in a timely manner. They expertise is best equipped to serve companies with strong consumer focus Retail, Financial, Communication and Marketing; identify their internal factors thereby helping them increase revenue. 5.2.2 Data Warehousing Data Warehousing concepts and tools have evolved and supported the key people in the enterprise with access to whatever level of information needed for the enterprise to survive and prosper in an increasingly competitive world. Kreara support with Business enhancement models Guidance for performance management Faster decision making Consolidated data analysis Analyze trends over time Data marts

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time responding to requests and business users spend less time looking for the information. By integrating data from across enterprise and delivering report and analysis we make predictive analysis, data and text mining, forecasting and optimization much more effective focusing on business concept. The process starts by determining key areas by consulting with all the people involved. The repository is easily accessible for frequently needed data and stored safely for extended period of time. Their analysis with larger sets of data support enterprise purposes. Storage and reporting services for smaller companies enable customers make insightful decisions about significant changes in their business world. 5.2.3 Pricing & Distribution Strategy Adopting the appropriate pricing and distribution strategy is one of the most important means to make a product or service successful in the competitive market. Kreara uses its statistical capabilities to extend guidance to clients to adopt the pricing and distribution strategies that are best suited for their product or service. Kreara uses data collected on crucial factors like product attributes, consumer demand, competitors pricing and market and economic trends to suggest different pricing and distribution strategies that will benefit the clients business. The statisticians at Kreara have knowledge in advanced computational techniques like Monte Carlo Simulation that can be applied in situations where the data is not sufficient for determining strategies.

5.3 SOFTWARE DEPARTMENT

Krishnakumar is the project manager for software Development in Kreara solutions. A Bachelor of Engineering in Electronics and communications from M S University Thirunelveli, Krishnakumar had worked as team leader and senior programmer for

various projects over the last 4 years. 5.3.1 Focus Areas The main focus areas of Kreara include clinical data management and statistical analysis for clinical trials. They also design electronic CRF(case report form) and IMK VARKALA Page 48

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electronic randomisation applications. Their statisticians provide valuable inputs into the study design and the selection of the statistical procedures. In the business intelligence sector, we perform data cleaning and analysis and help the enterprises to make informed decisions. They also develop and test custom software application for the automated conduct of clinical trials like clinical trial management systems. As part of our expansion plans, Kreara intend to provide development and analysis services in the bio-informatics and chem-informatics sector. 5.3.2 Agile Development

CHART 5.4.2 AGILE DEVELOPMENT Their software development practices agile development process-scrum model. The development works on Sprints with small increments that reduces the re modeling time. Key business links are identified during these increments through planning. In each Sprint the team will work through Requirements, Design, Coding, Unit Testing and User Acceptance Testing. Key Advantages Quality customer & business centric deliverables

Analysis, planning & implementing expertise Time & cost effectiveness Proficient people & domain expertise Page 49

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5.3.3 Software Quality Assurance The business automation services hosted in any environments are vulnerable to crashing when end user performs irregular transactions. At Kreara we ensure that the services resume normal in any abnormal scenarios by implementing the best Quality Assurance methodologies. Their Quality Assurance practices are best coupled with agile development process to deliver best results. Analysis is performed from user stories to performance testing. Testing team is well versed in Automation Testing, Manual Testing, Performance Testing, database Testing UAT and Regression. Quality Practices Integrated to agile practices Business modeling & requirements management specializations Automation & data driven testing expertise Frequent verification & validation practices Performance testing

5.4 INFORMATION TECHNOLOGY DEPARTMENT

Krearas IT services evolved out from the outsourced software and analytics center catering to both domestic and international clients. Professionals in Software Development, Software Testing and Statistics experienced in the latest technology and architectures, lead the business delivery by analyzing business requirements and providing scalable and robust solutions. Their product development expertises are channeled to Leading CROs and SaaS vendors. The Research Informatics team in Kreara specializes in delivering innovative IT solutions that utilize cross-functional expertise in software development and scientific research. The Research Informatics group comprises of a dedicated team of highly motivated software professionals who are cross-trained in Informatics, IT and Science. The team has experience in executing

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applications in programming, web development and data integration for discovery, research and development. Kreara expertise and focal areas in research informatics include Research Information Management Systems Pipelining protocols and scripts Technologies - Text mining, Image processing. Data mining Web based user interface - Portals, Dashboards Informatics Tools Workflow automation ELN/LIMS workflows Registration & Tracking systems Instrumentation Applications and interfaces Bar-coding /Scheduling software

5.5 HUMAN RESOURCE DEPARTMENT

In KREARA, administrative department has much importance. The functions included in this department are: Recruitment Selection Training

Functions: Recruitment The staff members are mainly selected through written tests and interview conducted by HR department of the company.

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Training On-Job-Training is given to employees . After joining the company every employees abilities and skill are evaluated on a test (Skill Matrics) Promotion , increment and annual bonus are given to the employees on basis of their seniority, skills ability and work performance.

HR MANAGER

HR EXCUTIVE

CHART 5.6 ADMINISTRATION DEPARTMENT

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CHAPTER VI SWOT ANALYSIS AND PEST ANALYSIS

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6.1 SWOT ANALYSIS A scan of the internal and external environment is an important part of the strategic planning process. Environmental factors internal to the firm usually can be classified as strengths (S) or weaknesses (W), and those external to the firm can be classified as opportunities (O) or threats (T). Such an analysis of the strategic environment is referred to as a SWOT analysis.

SWOT Analysis Framework

Environmental Scan / Internal Analysis /\ Strengths Weaknes ses | \ External Analysis /\ Opportunities Thr eats

SWOT Matrix

TABLE 6.2 SWOT ANALYSIS FRAMEWORK

The SWOT Matrix

A firm should not necessarily pursue the more lucrative opportunities. Rather, it may have a better chance at developing a competitive advantage by identifying a fit between the firm's strengths and upcoming opportunities. In some cases, the firm can overcome a weakness in order to prepare itself to pursue a opportunity.

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To develop strategies that take into account the SWOT profile, a matrix of these factors can be constructed. The SWOT matrix (also known as a TOWS Matrix) is shown below:

SWOT / TOWS Matrix

Strengths Weaknesses S-O strategies S-T Threats strategies W-O strategies W-T strategies

Opportuniti es

TABLE 6.1.1 SWOT / TOWS Matrix

S-O strategies pursue opportunities that are a good fit to the company's strengths.

W-O strategies overcome weaknesses to pursue opportunities. S-T strategies identify ways that the firm can use its strengths to reduce its vulnerability to external threats.

W-T strategies establish a defensive plan to prevent the firm's weaknesses from making it highly susceptible to external threats.

6.1.1 STRENGTHS Customers- the KREARA have very good understanding

customers. Employees- the company employees are very sincere & hard woring and fully dedicated to their work . Efficient co ordination and communication among employees. Speed and punctuality of employees. Management- the firm has highly committed and confident management team to support the growth and development of the organisation. IMK VARKALA Page 55

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Kreara possesses a long chain of customers. The Company has well-qualified and experienced human resource department which can be effectively utilized for tapping the opportunities. It helps the company to achieve the target easily.

6.1.2WEAKNESSES Lack of efficient manpower Low growth rate of the industry in domestic sector . Lack of business connections in the national or international level. Number of partners and clients are low.

6.1.3 OPPORTUNITIES The organisation is fast growing one, soon opening a new office also in tecknopark and company is planing more expansion in the recent future. To expand their clinical research industry in the world , and have a strong or emerging biotech sector, a large patient population and/or contract research organizations with global reach, and are ahead of the curve in adopting electronic health records and/or have the ability to tap into the large national databases that are being built.

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Govt rules and regulations.

6.2 PEST ANALYSIS

6.2.1 POLITICAL ANALYSIS Kreara is a private sector company and situated in technopark .The park campus is like a special economic zone. Normally the external politics are not influencing in companies and the employees are also not interested in the external politics .And they donot have any poitical union or political leadership.

6.2.2 ECONOMIC ANALYSIS Kreara is a small company and the number of employees are not so huge and the company is dealing with clinical service sector .so the company doesnot make any direct influence in the society and doesnt have large investment or marketing expense . Global economic factor dont affect the companys growth. During the recession period also the company had a positive annual growth.

6.2.3 SOCIAL ANALYSIS Kreara is small company .The direct employees are below 100.The company doesnt make any direct social influence in the society.

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Directly or indirectly the company does contribute to the betterment of the society. The company engages in social activities like blood donation and personal computer distribution to govt schools. The company conducts several social and cultural events. The company is dealing in clinical and human science . Thus they contributing their work and service to the society

6.2.4 TECHNOLOGICAL ANALYSIS The company does regular technological updations so as to survive in the competitive field.

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CHAPTER VII FINDINGS , CONCLUSION AND SUGGESTIONS

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7.1 FINDINGS The study review funtioning of a private sector company. The company is a prototype of corporate management. The employees are happy on the facilities and benefits given by the company. The company deals with human science with the help of IT industry. All the employees are highly qualified and efficient on working.

The marketing of the company is not good, the Advertisement are not efficient and popular. Number of employees is low. Partners and clients are limited. Low domestic growth rate of the companys working sector.

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7.8 CONCLUSION

The report reveal about a private sector company which deals in clinical service .kreara solution is a small company and therefore it doesnt make any direct impact on the economy or other industries. Redressing this requires a holistic approach, from both a demand and supply side. The goal is to work towards developing a business culture that value service as an integral part of the innovation process and an active sevice sector supporting all aspects of business. The word ORGANISATION stands for association, groups, company etc, key to success and growth of a company primarily comes from the employees and from the good guidance/governance of the management. Success and growth of an organization also depends on the optimum use of available resources.

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7.3 SUGGESTIONS The company performs their duties and responsible in a good way and they achieves their targets in time. The company is dealing with the employees in a good mannered way. The company should provide more advertisements. The company have to improve their infrastructure. Have to get good bussiness partners and more clients. Have to improve the work force.

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BIBLIOGRAPHY

REFERENCES

BOOKS 1. 2. Sekaran Uma,(2006), Research Methods for Business: A Skill Building Kothari C.R, (2005), Research Methodology Methods & Techniques, New Websites 1. www.kreara.com 2. www.wikipedia.com IMK VARKALA Page 64 Approach, New Delhi: John Wiley & Sons, Inc. Delhi: New age international publishers

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3. www. Scribid .com

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APPENDIX

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