India has close to 70 million people affected by rare diseases in a population above 1.3 billion people. This corresponds to about one fifth of all rare disease cases globally. As the globally operating biopharmaceutical industry often struggles to find enough patients for their clinical trials and rare diseases don’t stop at borders, India represents an attractive location to accelerate patient recruitment and to collect a sufficient amount of data for analysis.
This webinar will explore why India represents as an attractive country to conduct rare disease trials, by delivering a thought-provoking session including a case study to highlight how India can fit into the global picture of international trials. Orphan Reach has had an established presence in India since 2012. With a robust infrastructure in place across the country, the company has gained important experience allowing them to find patients in many rare disease areas and to reliably conduct clinical trials.
We will explore details regarding obtaining central and local approvals, to support sites and how to monitor these trials locally given the challenges around rare disease complexities. We will also cover how to manage vendors (locally) and centralised data liaison activities for trial success in India.
The patient experience and perspective are of utmost importance to all clinical trials and therefore we will also hear from the Organisation for Rare Diseases India, who will focus on how ORDIndia is enabling rare disease diagnostic and therapeutic program deployment in India. In addition to an overview of current rare disease regulations, with a focus on the impact of the latest guidelines outlined by the Indian Government in 2019 and what this means for clinical research in the country.
If you’re considering site and patient recruitment in India, register for this webinar to utilize Orphan Reach’s experience to assist you getting started.
Key Learning Objectives
- Learn why India is an attractive country for conducting rare disease clinical trials
- How to obtain central and local approvals, to support sites in India
- How to monitor these trials locally given the complexities of rare disease trials
- How to ensure a positive patient experience
