researching for

tomorrow,
8/7 F-Block, Qutab Enclave, DLF Phase - 1, Gurgaon - 122002, Haryana, India
Tel: +91-124-510 42 00 Fax: +91-124-510 42 03
today.
www.clinrx.com
 Founded over 100 years ago, it is one of the leading private sector We are a team of highly qualified, experienced,
groups in India, with a turnover of over US$ 1 billion. It is a well-trained and competent clinical scientists.
conglomerate of industrial and commercial companies, and
charitable trusts. Its member companies employ nearly 50,000
persons, engaged in the manufacture of variety of products in
diverse fields of commerce. It has a global presence with
manufacturing operations and outsourcing arrangements all over
the world and exports spanning across 60 countries in 6
continents.

The JK products range from automobile tyres and rubber products,

papers, hybrid seeds, cement, textiles to garments, to sugar and
Mr. Sanjay Mitter , M.Sc. Statistics from Concordia University and M.Sc
dairy products. Most of the Group Companies are market leaders in Mathematics/Computer Science from IIT, has over thirteen years of experience in the
life science industry in data management including representing the multinational
their product categories, with strong brands. Most of these sponsor companies to the FDA/other regulatory agencies meetings.
businesses are public limited companies, and are quoted on the
stock exchanges with large number of public shareholders.

Success of the organization is based on the use of latest

technology, continuous research and development, and
innovation. Most of the group plants have ISO 9001 certification,
and some have also earned QS 9000 and ISO 14001 certifications.
Mr. Sanjay Mitter , M.Sc. Statistics from Concordia University and M.Sc
The group has received various awards for the betterment of Mathematics/Computer Science from IIT, has over thirteen years of experience in the
environment and for export achievements. life science industry in data management including representing the multinational
sponsor companies to the FDA/other regulatory agencies meetings.

The group's endeavor is to improve the quality of life of people, for

which it has set up a large number of institutions of excellence in
the areas of education and healthcare. One such example is the
Pushpawati Singhania Research Institute for Liver, Renal, and
Digestive diseases in New Delhi. It is Asia's only Super Speciality
Hospital of its kind.

The JK Organization has a culture of innovation and continually Mr. Sanjay Mitter , M.Sc. Statistics from Concordia University and M.Sc
Mathematics/Computer Science from IIT, has over thirteen years of experience in the
looks out for areas to diversify its business and attain a leadership life science industry in data management including representing the multinational
sponsor companies to the FDA/other regulatory agencies meetings.
position there in. Its recent expansion is in the area of clinical
research. The company's passion for excellence to perform the
best and its commitment to the cause of human advancement
makes it a strong contender for a significant role in global research
business.
ORGANIZATION PEOPLE
 VISION

CliniRx has been set up with the vision of adding value to high
quality clinical trials. CliniRx aims to serve as an interface
between quality-conscious international companies and highly
Doctors professional, experienced clinical trial sites. CliniRx provides a
Post Graduates full spectrum of services ranging from sites selection to report
Graduates writing thereby making it a full service CRO. Our data
management services run on the world's best platform. The
same is true of the human faces behind our clinical activities.

Qualifications of CliniRx personnel

25
20
15
10
Highly
5 qualified &
0 experienced
Principal
Lead Clinician Project Manager personnel
Investigator

Experience of CliniRx personnel under various capacities for different therapeutic areas
Full-service Commitment
CRO to Quality
Cardiovascular System
Dermatology Neurology
Musculoskeletal System Gastrointestinal System
Oncology
Surgery
Infectious Diseases & Infections
Psychiatry
OUR
Diabetology Respiratory System
STRENGTHS
Experience of CliniRx personnel in various therapeutic areas
Customization
to client Consistency
40
requirement
30
Principal Investigator
20 Lead Clinician State of art
Project Manager
10 infrastructure
0
Phase II Phase III Phase IV

Experience across clinical study phases

EXPERIENCE ABOUT CLINRX

FEASIBILITY STUDIES
Comprehensive feasibility report covering detailed information on the below listed
areas can be compiled by a team of professionals consisting of medical, project
management and regulatory representatives.
· Background information on disease under the study relevant to India
· Proposed list of investigators and sites with enrollment expectations
· Requirement for regulatory approvals
· Study timelines
· Proposed monitoring plan
· Budget estimation
This feasibility report aims to provide the client all
information required to make an educated decision in trial
placement.

PROTOCOL & STUDY DOCUMENT DEVELOPMENT

At CliniRx we believe that the study protocol is the blue
print of the trial. High quality workable protocols can be
developed as per requirements of the client in
compliance with all applicable regulatory requirements.
The protocol development team has representation from
clinical research, statistics, regulatory areas as well as
include therapeutic area experts.
CliniRx also has expertise to develop informed consent
documents and case report forms in compliance with the
protocol and applicable regulations.

REGULATORY FUNCTIONS
We are well versed and updated about all the national & international
regulatory requirements for the conduct of clinical trials. Therefore, high quality
regulatory dossiers are prepared to meet the requirements. We arrange for the
submission of all required documents for approval by regional regulatory authorities and
other required governmental departments. We organize all licenses and other permissions

COMPREHENSIVE
COVERAGE MATTER PANKAJ
 Clinicals Software Suite

At CliniRx, we work on the complete Oracle Clinicals Software Suite

including the following softwares:
· Oracle Clinicals
· Oracle Thesaurus Management System
· Oracle Remote Data Capture
Anesthesiology
· Oracle Adverse Event Reporting System
Cardiology
· Oracle Clinical Trial Minder
Cardiothoracic surgery
· Oracle Clinical Site Minder
Diabetology
CliniRx is the only CRO that uses all the Oracle Clinicals Softwares
Endocrinology for conduct of clinical trials right from the planning stage till the
Gastroenterology very end of the project with report generation. Oracle Clinicals is
Geriatrics a powerful, comprehensive clinical data management solution.
Oracle Clinicals allows to standardize and control data definitions
Hematology and data usage across global operations, ensuring that data is
Infectious disease defined, managed, and interpreted consistently worldwide. This
Intensive Care expedites the multinational regulatory approval process and
reduces cycle times in critical clinical trial processes, thereby
Nephrology accelerating time to market for new products.
Neurology We use Oracle Remote Data Capture System and Oracle
Oncology Thesaurus Management System to support our Data Management
Ophthalmology and Adverse Event Reporting System.
Otolaryngology For the first time in India, CliniRx is using the integrated Oracle
Software Suite to handle Data Management, Medical Monitoring,
Pediatrics
Pharmacovigilance and Clinical Trial Management.
Primary Care We, at CliniRx, lay a strong emphasis on patient safety reporting.
Psychiatry Oracle Adverse Event Reporting System is a comprehensive
Pulmonary Medicine solution for product safety monitoring and compliance. Oracle
AERS provides the highest quality and functionality of any
Rheumatology
adverse event reporting system.
Women's Health
CliniRx is one of the only two CROs in India to use Oracle Adverse
Reporting System for managing adverse events.
We manage our trials with Oracle Clinical Trial Minder and Oracle
Clinical Site Minder. Oracle Clinical Site Minder provides support
to administrative and financial aspects of running clinical trials at
an investigative site. Oracle Clinical Trial Minder provides the
same perspective for the Sponsor/CRO. These softwares bring
new levels of automation and integration to the conduct of
clinical trials.
CliniRx is the only CRO in India to use Oracle Clinical Site Minder and
Oracle Clinical Trial Minder for conduct of clinical trials.

KEY THERAPEUTIC
AREAS ORACLE
 PROJECT MANAGEMENT & STUDY MONITORING
At CliniRx, site management begins with the selection of sites and is completed only
after their successful closure. Efficient and competent clinical research team from
our organization oversees the conduct of the clinical trial at the site in
accordance with the protocol, ICH GCP guidelines, SOPs, applicable
regulatory, and sponsor's requirements. Our monitors are well conversant
with the clinical trial procedures and provide specialists knowledge and
facilities required for the study. Our proactive approach identifies

PHARMACOVIGILANCE
In trials managed by our team subject safety holds the highest
priority. A round the clock coverage to receive SAE reporting
will be available. Expert medical guidance will also be available
if investigators wish to discuss any aspect regarding safety.
Adequate processes to meet safety reporting obligation
towards Indian regulatory authority are in place and would be
customized to sponsors safety reporting requirements.

GCP TRAINING
Our team has the expertise to conduct ICH GCP training and workshops for
clinical research professionals. Prior to initiating trials, we ensure that all
investigators and site personnel are well trained in GCP. We also offer training in
GCP for institutions, pharma companies and clinical research organizations. Our
team members are invited as faculty in clinical research related seminars, workshops
and conferences.

COMPREHENSIVE
STUDIES COVERAGE