RESEARCHING FOR

TOMORROW, TODAY.

8/7 F-Block, Qutab Enclave, DLF Phase - I, Gurgaon - 122 002, Haryana, India
Tel: +91-124-510 42 00 Fax: +91-124-510 42 03 www.clinirx.com
 JK ORGANIZATION CLINRX
EXPERIENCE

Founded over 100 years ago, it is one of the leading private sector groups in India, with a turnover of over US$ 1
Doctors
billion. It is a conglomerate of industrial and commercial companies, and charitable trusts. Its member companies Post Graduates
Graduates
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. Qualifications of CliniRx personnel

25
The JK products range from automobile tyres and rubber products, papers, hybrid seeds, cement, textiles to 20
15
garments, to sugar and dairy products. Most of the Group Companies are market leaders in their product categories, 10
5
with strong brands. Most of these businesses are public limited companies, and are quoted on the stock exchanges 0
Principal
Lead Clinician Project Manager
with large number of public shareholders. Investigator

Experience of CliniRx personnel under various capacities for different therapeutic areas
Success of the organization is based on the use of latest technology, continuous research and development, and
Cardiovascular System
innovation. Most of the group plants have ISO 9001 certification, and some have also earned QS 9000 and ISO Dermatology Neurology
Musculoskeletal System Gastrointestinal System
Oncology
14001 certifications. The group has received various awards for the betterment of environment and for export Surgery
Infectious Diseases & Infections
Psychiatry
Diabetology Respiratory System
achievements.
Experience of CliniRx personnel in various therapeutic areas
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
40
excellence in the areas of education and healthcare. One such example is the Pushpawati Singhania Research Institute
30
for Liver, Renal, and Digestive diseases in New Delhi. It is Asia's only Super Speciality Hospital of its kind. Principal Investigator
20 Lead Clinician
Project Manager
10
The JK Organization has a culture of innovation and continually looks out for areas to diversify its business and attain
0
Phase II Phase III Phase IV
a leadership position there in. Its recent expansion is in the area of clinical research. The company's passion for
Experience across clinical study phases
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.

As on 01 Mar 2006
 SAS SOFTWARE VISION ABOUT CLINIRX
Clinicals Software Suite

At CliniRx, we work on the complete Oracle Clinicals Software Suite including the following softwares: CliniRx has been set up with the vision of adding value to high quality clinical
· Oracle Clinicals trials. CliniRx aims to serve as an interface between quality-conscious
international companies and highly professional, experienced clinical trial
· Oracle Thesaurus Management System sites. CliniRx provides a full spectrum of services ranging from sites selection
· Oracle Remote Data Capture to report 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
· Oracle Adverse Event Reporting System
faces behind our clinical activities.
· Oracle Clinical Trial Minder
· Oracle Clinical Site Minder
CliniRx is the only CRO that uses all the Oracle Clinicals Softwares for conduct of clinical trials right from the
planning stage till the very end of the project with report generation. Oracle Clinicals is a powerful, Highly
comprehensive clinical data management solution. Oracle Clinicals allows to standardize and control data qualified &
definitions and data usage across global operations, ensuring that data is defined, managed, and interpreted experienced
personnel
consistently worldwide. This expedites the multinational regulatory approval process and reduces cycle times in
critical clinical trial processes, thereby accelerating time to market for new products.
Full-service Commitment
We use Oracle Remote Data Capture System and Oracle Thesaurus Management System to support our Data CRO to Quality
Management and Adverse Event Reporting System.
For the first time in India, CliniRx is using the integrated Oracle Software Suite to handle Data Management,
Medical Monitoring, Pharmacovigilance and Clinical Trial Management. OUR
We, at CliniRx, lay a strong emphasis on patient safety reporting. Oracle Adverse Event Reporting System is a STRENGTHS
comprehensive solution for product safety monitoring and compliance. Oracle AERS provides the highest quality
and functionality of any adverse event reporting system. Customization
CliniRx is one of the only two CROs in India to use Oracle Adverse Reporting System for managing adverse to client Consistency
events. requirement

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. State of art
Oracle Clinical Trial Minder provides the same perspective for the Sponsor/CRO. These softwares bring new infrastructure
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.
 NEUROLOGY OUR STUDIES
Parkinson’s disease is an idiopathic neuro-degenerative disorder characterized
clinically by tremor, rigidity, akinesia, and loss of postural reflexes. A phase III double-
blind, placebo-controlled study is being conducted to determine the efficacy and safety
of a selective, reversible MAO-B inhibitor as add-on therapy in idiopathic Parkinson’s
disease. This is a multinational trial involving approximately 30 sites in India, and 10
sites each in Italy and Romania. Approximately 650 patients are being enrolled into the
study. The six-month initial study is to be followed by a 1 year blinded extension study.
WHAT TO PUT HERE? WHAT TO PUT
Parkinson’s disease is an idiopathic neuro-degenerative disorder characterized
clinically by tremor, rigidity, akinesia, and loss of postural reflexes. A phase III double-
blind, placebo-controlled study is being conducted to determine the efficacy and safety
of a selective, reversible MAO-B inhibitor as add-on therapy in idiopathic Parkinson’s
disease. This is a multinational trial involving approximately 30 sites in India, and 10
sites each in Italy and Romania. Approximately 650 patients are being enrolled into the
study. The six-month initial study is to be followed by a 1 year blinded extension study.
 KEY THERAPEUTIC OUR STUDIES
AREAS
NEUROLOGY

Parkinson’s disease is an idiopathic neuro-degenerative disorder characterized

clinically by tremor, rigidity, akinesia, and loss of postural reflexes. A phase III double-
Anesthesiology Hematology Otolaryngology
Cardiology Infectious disease Pediatrics
blind, placebo-controlled study is being conducted to determine the efficacy and safety
Cardiothoracic surgery Intensive Care Primary Care of a selective, reversible MAO-B inhibitor as add-on therapy in idiopathic Parkinson’s
Diabetology Nephrology Psychiatry disease. This is a multinational trial involving approximately 30 sites in India, and 10
Endocrinology Neurology Pulmonary Medicine sites each in Italy and Romania. Approximately 650 patients are being enrolled into the
Gastroenterology Oncology Rheumatology
study. The six-month initial study is to be followed by a 1 year blinded extension study.
Geriatrics Ophthalmology Women's Health
 COMPREHENSIVE
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 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.
COMPREHENSIVE
COVERAGE
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
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 possible shortcomings of the study and takes appropriate action well in
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
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.