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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

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 certification, and some have also earned QS 9000 and ISO 14001 certifications. The group has received various 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 in New Delhi. It is Asia's only Super Speciality Hospital of its kind. The JK Organization has a culture of innovation and 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 contender for a significant role in global research business.
Anesthesiology Cardiology Cardiothoracic surgery Diabetology Endocrinology Gastroenterology Geriatrics

KEY THERAPEUTIC AREAS
Hematology Infectious disease Intensive Care Nephrology Neurology Oncology Ophthalmology Otolaryngology Pediatrics Primary Care Psychiatry Pulmonary Medicine Rheumatology Women's Health

COMPREHENSIVE COVERAGE
REGULATORY FUNCTIONS 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.

COMPREHENSIVE COVERAGE

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.

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 advance.

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.

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.

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 COVERAGE
BIOMETRICS
We efficiently undertake management of clinical trial data. Using internationally approved software platforms, data management experts at CliniRx offer accurate collection, organization, validation, statistical analysis and reporting of clinical trial data. Our experienced, expert biostatisticians provide all types of biostatistical services for clinical trial management.

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 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.

ABOUT CLINIRX

MEDICAL WRITING
We have qualified professionals from various disciplines proficient to carry out high quality medical writing. Our scientific and medical writers will be committed to ensure clarity and accuracy of all reports/manuscripts. Credited with publications in varying medical journals, CliniRx experts produce clinical manuscripts of high standard that have international acceptance.

QUALITY ASSURANCE SERVICES
Our organization emphasizes 'Quality' in all the activities. Our staff has an in-depth knowledge of procedures, and is adequately trained in quality management systems. Besides assuring quality for our managed trials, we also offer quality assurance services as per client's need. We will be able to conduct audits of our own organization as well as other sites and studies.
Full-service CRO

Highly qualified & experienced personnel

Commitment to Quality

OUR STRENGTHS
Customization to client requirement State of art infrastructure

MEDICAL SUPPORT SERVICES
We have expert medical doctors who provide high standard medical monitoring for clinical trials. They review eligibility criteria to ensure appropriate subject enrollment. Our medical experts review and keep track of all the adverse events and take appropriate actions. We provide 24 hours help lines where required for discussing study queries or issues from investigators. We will also offer facilities for review of laboratory data.

Consistency