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Our Services
What We Do – Bridging the Needs
 Western Pharma companies need to increase productivity, decrease costs, and shorten the time to market for new drugs. One solution is conducting clinical trials that provide lower cost and faster recruitment without compromising the quality of the research. India clearly offers this solution. In the past, several constraints have limited the number of clinical trials conducted in India:
- Communication can be an issue because of cultural differences between Western countries and India.
- The difference in time zones creates further difficulties in communication and monitoring of work.
- There are some significant differences between Western and Indian business culture.
- Indian researchers need to clearly understand the requirements of Western pharmaceutical companies and their regulatory requirements.
- Western companies need to overcome their perception of India as a non-traditional “developing” nation that is the “land of the generics” with limited capacity and uncertain quality of work.
These issues are not unique to clinical trials. Similar issues have been faced and successfully addressed in fields such as information technology (IT) and business process outsourcing (BPO), where India is now a leading provider of services to Western clients. IndiPharm was established to provide a “bridge” to Western clients interested in conducting clinical trials in India. IndiPharm executives have taken advantage of the lessons learned in IT, BPO and other fields to create an organization that provides a strong Western presence for client interface and client services combined with an Indian operation that can execute projects and programs efficiently and effectively.
IndiPharm Capabilities
- Phase I
- Bioavailability/Bioequivalence
- Thorough QTc Studies
- Proof of Concept studies
- Phase II/III Efficacy Studies
- Phase IV Studies
- Medical Monitoring/Safety Reporting
IndiPharm Investigator Network (IIN)
 IndiPharm’s Indian subsidiary, IndiPharm (India) Private Limited, is located in Mumbai, India’s medical capital. With the assistance of the members of the Scientific Advisory Board, IndiPharm (India) has established highly qualified and trained staff in Mumbai and established the IndiPharm Investigator Network (IIN), a network of highly experienced clinical investigators who have extensive experience in multinational clinical trials in a wide range of therapeutic areas. Members of the IIN are in the major Tier I and Tier II cities in India, are all ICH/GCP compliant, include leading academic as well as private research centers, and have established Independent Review Boards.
IndiPharm Sites
The investigator sites offer IFCC compliant laboratories with access to a common laboratory network. Most of these sites are routinely audited by a wide range of international organizations. Each site meets the needs of global clinical trials and each is very “recruitment-friendly.” Over 90% of the investigators at these sites are either U.S. or U.K. trained and most are U.S. Board certified. The characteristics of the sites include:
- Major Tier I and Tier II Cities
- Leading Academic and Private Centers
- ICH/GCP compliant
- Audited multiple times
- Independent IRBs/ECs
- Scientific Committees
- Recruitment-friendly
Therapeutic Areas -
Indipharm offers extensive experience and
capabilities in all therapeutic areas, including:
- Oncology
- Infectious Diseases
- Metabolism, Diabetes & Obesity
- Cardiovascular
- Gastroenterology
- Neuropsychiatry
- Pain and Rheumatology
- Women’s Health
- Ophthalmology
- Medical Devices
As an example, IndiPharm has, in the therapeutic area of Oncology, established a strategic alliance with the Indian Cooperative Oncology Network, whose mission is to expand the availability of oncology investigative sites and provide greater treatment options for patients in India. The Head of, the Indian Cooperative Oncology Network, Dr. Purvish Parikh, is a member of IndiPharm’s Scientific Advisory Board, and has led most of the Indian Cooperative Oncology Network’s multinational oncology trials.
IndiPharm Services
IndiPharm offers a full range of CRO services to Western biotechnology, pharmaceutical and medical device companies. These services include:
- Identification of experienced sites and Good Clinical Practices-trained investigators for the purposes of conducting its clients’ clinical trials
- All regulatory submissions required in connection with the clinical trials
- Obtaining all required licenses for the import and export of any drugs and/or patient materials from the client’s country of origin to India and back
- All Institutional Review Board/Ethics Committee submissions
- Clinical protocol preparation including definition of the medical issues to be examined, the number of patients required to produce statistically valid results, the period of time over which they must be tracked, the frequency and dosage of drug administration, and the study procedures
- Site monitoring/site audits to ensure that case report forms have been completed in accordance with the applicable study protocol and Good Clinical Practices
- Medical Monitoring/Safety Reporting
- Coordination of central lab logistics and sample handling, including receiving and packaging drugs according to the appropriate protocol and reconciling these drugs in connection with a particular clinical trial (these services can expedite the drug development process because clinical trials are often postponed by delays in the manufacture and distribution of study drug materials)
- Clinical data management, including the accurate collection, organization, validation, and analysis of clinical data
- Bio-statistical analysis and interpretation, including development and review of protocols, design of appropriate analysis plans, and design of report formats to address the objectives of the study protocol as well as the client’s individual objectives
- Creation of medical communications to assure that the study results are appropriately and effectively shared with different audiences.
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