researching for

tomorrow, today.

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
www.clinrx.com

Founded over 100 years ago, it is one of the leading
private sector groups in India, with a turnover of over US$
1 billion. It is a 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 dairy products. Most of the Group
Companies are market leaders in their product categories,
with strong brands. Most of these 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
ORGANIZATION PEOPLE
certification, and some have also earned QS 9000 and ISO We are a team of highly qualified, experienced,
14001 certifications. The group has received various well-trained and competent clinical scientists.
awards for the betterment of environment and for export
achievements.
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 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
in New Delhi. It is Asia's only Super Speciality Hospital of life science industry in data management including representing the multinational
sponsor companies to the FDA/other regulatory agencies meetings.
its kind.
The JK Organization has a culture of innovation and
Mr. Sanjay Mitter , M.Sc. Statistics from Concordia University and M.Sc
continually looks out for areas to diversify its business and Mathematics/Computer Science from IIT, has over thirteen years of experience in the
life science industry in data management including representing the multinational
attain a leadership position there in. Its recent expansion sponsor companies to the FDA/other regulatory agencies meetings.
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 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
business. life science industry in data management including representing the multinational
sponsor companies to the FDA/other regulatory agencies meetings.
 EXPERIENCE ABOUT CLINRX
Highly
qualified &
Doctors
experienced
Post Graduates
Graduates personnel

Full-service Commitment
CRO to Quality
Qualifications of CliniRx personnel

25
20
OUR
15
10 STRENGTHS
5
0
Principal
Investigator
Lead Clinician Project Manager Customization
to client Consistency
Experience of CliniRx personnel under various capacities for different therapeutic areas requirement

Cardiovascular System State of art

Dermatology Neurology infrastructure
Musculoskeletal System Gastrointestinal System
Oncology Infectious Diseases & Infections
Surgery Psychiatry
Diabetology Respiratory System

CliniRx has been set up with the vision of adding value to high
Experience of CliniRx personnel in various therapeutic areas quality clinical trials. CliniRx aims to serve as an interface
between quality-conscious international companies and highly
professional, experienced clinical trial sites. CliniRx provides a
full spectrum of services ranging from sites selection to report
40 writing thereby making it a full service CRO. Our data
30 management services run on the world's best platform. The same
Principal Investigator is true of the human faces behind our clinical activities.
20 Lead Clinician
Project Manager
10
0
Phase II Phase III Phase IV

Experience across clinical study phases

 COMPREHENSIVE
MATTER
COVERAGE
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

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 regulator y
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 required for export and import of drugs and biological.
KEY THERAPEUTIC Clinicals Software Suite

AREAS
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.
 COMPREHENSIVE
STUDIES
COVERAGE
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

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

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.