Brochure2

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

ORGANIZATION Founded over 100 years ago, it is one of the leading

certification, and some have also earned QS 9000 and ISO

private sector groups in India, with a turnover of over US$

14001 certifications. The group has received various

1 billion.

awards for the betterment of environment and for export

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.

We are a team of highly qualified, experienced, well-trained and competent clinical scientists.

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 in New Delhi. It is Asia's only Super Speciality Hospital of its kind.

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 life science industry in data management including representing the multinational sponsor companies to the FDA/other regulatory agencies meetings.

The JK Organization has a culture of innovation and 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 life science industry in data management including representing the multinational sponsor companies to the FDA/other regulatory agencies meetings.

continually looks out for areas to diversify its business and attain a leadership 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

Success of the organization is based on the use of latest

contender for a significant role in global research

technology, continuous research and development, and

business.

innovation. Most of the group plants have ISO 9001

PEOPLE

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 life science industry in data management including representing the multinational sponsor companies to the FDA/other regulatory agencies meetings.

EXPERIENCE

ABOUT CLINRX Highly qualified & experienced personnel

Doctors Post Graduates Graduates

Full-service CRO

Commitment to Quality

Qualifications of CliniRx personnel

OUR STRENGTHS

25 20 15 10 5 0

Principal Investigator

Lead Clinician

Project Manager

Experience of CliniRx personnel under various capacities for different therapeutic areas

Cardiovascular System Dermatology Musculoskeletal System Oncology Surgery Diabetology

Neurology Gastrointestinal System Infectious Diseases & Infections Psychiatry Respiratory System

Experience of CliniRx personnel in various therapeutic areas

40 30 Principal Investigator Lead Clinician Project Manager

20 10 0

Phase II

Phase III

Phase IV

Experience across clinical study phases

Customization to client requirement

Consistency

State of art infrastructure

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 professional, experienced clinical trial sites. CliniRx provides a full spectrum of services ranging from sites selection 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 faces behind our clinical activities.

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

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.

MATTER

KEY THERAPEUTIC AREAS

Clinicals Software Suite

At CliniRx, we work on the complete Oracle Clinicals Software Suite including the following softwares: · Oracle Clinicals · Oracle Thesaurus Management System

Anesthesiology Cardiology Cardiothoracic surgery Diabetology Endocrinology Gastroenterology Geriatrics Hematology Infectious disease Intensive Care Nephrology Neurology Oncology Ophthalmology Otolaryngology Pediatrics Primary Care Psychiatry Pulmonary Medicine Rheumatology Women's Health

· Oracle Remote Data Capture · Oracle Adverse Event Reporting System · 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, comprehensive clinical data management solution. Oracle Clinicals allows to standardize and control data definitions and data usage across global operations, ensuring that data is defined, managed, and interpreted 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. We use Oracle Remote Data Capture System and Oracle Thesaurus Management System to support our Data 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. We, at CliniRx, lay a strong emphasis on patient safety reporting. Oracle Adverse Event Reporting System is a comprehensive solution for product safety monitoring and compliance. Oracle AERS provides the highest quality and functionality of any adverse event reporting system. 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.

STUDIES

COMPREHENSIVE 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.