India presents a compelling environment for global clinical trials because of its access to investigators, large patient populations with diseases of the industrialized and developing world, a cost-effective, English-speaking graduate workforce, and progressive regulatory environment. These benefits are now well recognized by the global pharmaceutical industry. Moreover, because of India's pristine FDA audits, continued streamlining of regulatory approvals and demonstrated intent to uphold international intellectual property standards, the country has become even more attractive as an important locale for clinical development.
As a result, multinational pharmaceutical companies are striving to build clinical development capabilities within their local operating companies in India, and the country's nascent CRO industry is enjoying an annual growth of about 40%. This, however, poses resourcing constraints and unresolved ethical issues about the robustness of patient consent. Hence, it is becoming increasingly important for sponsors to select investigators, sites and resources that will be able to deliver data of the quality and integrity that they seek.
This presentation draws on recent experiences and case studies related to the benefits and challenges of conducting clinical trials as well as data management in India.
This audio conference covers:
- The benefits of conducting clinical development in India
- Recognizing the potential challenges
- Understanding the dynamism of the current clinical development atmosphere
- How to utilize the opportunities to best meet sponsor needs
About the speaker:
Dr. Nermeen Varawalla leads the corporate development effort for India at PRA International. Dr. Varawalla has a strong interest in the utilization of emerging world countries for global clinical trials and has established PRA's capabilities in Mumbai and Pune, India.
Prior to joining PRA, Dr. Varawalla was the founder of PerinClinical, a niche India-focused CRO. Before that she worked with Accenture's Health & Life Sciences Business Consulting Practice in London in the area of drug development.
Dr. Varawalla received her medical training at the KEM group of hospitals, Mumbai, India. She was awarded the Rhodes Research Fellowship to the University of Oxford where she conducted her doctoral research in Molecular Genetics. Nermeen practiced as a specialist at two of the UK's leading NHS Hospitals. She then obtained her MBA at INSEAD. Dr. Varawalla is a recognized industry expert on clinical development in India and is a frequent and respected speaker at international conferences.
Who should attend?
- Heads of R&D
- VPs Clinical Development
- Directors of Clinical Operations
- Therapeutic Area Leaders
- Program and Clinical Study Managers
- Directors of Outsourcing and Procurement
- VPs Global Data Management