Parexel Execs On Regulatory Harmonization, AI Impact, RWE Challenges

Opportunity For RWE In India

From the US FDA’s ISTAND Program to EU’s Melloddy Initiative, and from the global challenges of real-world data to the opportunities in India, Parexel’s EVP for Clinical Data and Digital Services, chief strategy officer and India head speak on a range of topics in this interview with the Pink Sheet.

L-R - Parexel’s Kushal Gohil (Chief Strategy Officer), Sanjay Vyas (EVP and MD for India) and Stephen Pyke (EVP, Clinical Data and Digital Services) • Source: Pink Sheet/Citeline

In a world where pharmaceutical companies are expanding their commercial footprint across borders and where product pricing is coming in for greater scrutiny on home turf, the role of regulatory harmonization in keeping trial and drug approval costs lower is being closely followed.

The Pink Sheet regularly speaks to industry stakeholders on such issues and recently sat down with executives at Parexel International Corp., a major global provider of biopharma services including...

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