Expertise
 IndiPharm’s management team brings together an outstanding blend of international business, clinical research, and contract research expertise. Dilip Limaye’s expertise in the establishment of international business has been critical in the development of the structure and organization of Indipharm. Based on his expertise, Indipharm has established the operational headquarters in Mumbai and the executive and client service center in Radnor, PA.
Dr. Edward Brennan brings extensive medical and research experience across all phases of clinical development in multiple therapeutic areas. He has led teams which have filed more than 10 investigational New Drug applications as well as multiple New Drug Applications.
Dr. James A. Bannon brings more than 25 years of clinical research executive management experience in the leadership of multiple global CROs. He has grown these companies by consistently focusing on achieving high client and employee satisfaction resulting in long term client relationships and low employee turnover.
Therapeutic Areas
IndiPharm offers extensive experience and capabilities in a broad range of therapeutic areas, including:
- Oncology
- Infectious Diseases
- Metabolism, Diabetes & Obesity
- Cardiovascular
- Gastroenterology
- Neuropsychiatry
- Pain and Rheumatology
- Women’s Health
- Ophthalmology
- Medical Devices
Specifically, IndiPharm has 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 many of the Indian Cooperative Oncology Network’s multinational oncology trials. Under Dr. Parikh’s direction, Indipharm rapidly identifies and recruits the leading oncologists.
IndiPharm Services
IndiPharm provides a full range of CRO services to Western biotechnology, pharmaceutical and medical device companies. These s ervices include:
- Identification of experienced Good Clinical Practices-trained investigators
- All regulatory submissions required by DCGI and other agencies
- 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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