“Every company conducting medical research should have a code of conduct, and every clinical trial should have a protocol. Compliance begins here.”
With regulators often focusing on a product once it comes to market, compliance programs are regularly introduced late in the lifecycle of a product or company. At the same time, governance at the research and development stage has fallen behind, as evidenced by the recent resignation of a Chief Medical Officer of a US Cancer Hospital amid their failure to disclose ties to a company that did not yet have an FDA-approved product in their portfolio. Since implementing a compliance program early on means doing so when funding is typically low, this delay is not without reason. However, as FRA’s Mike Trahar points out, compliance monitoring from the get-go of development is likely to pay off in the end.
In his latest article for Policy and Medicine, Mike argues the importance of early monitoring and shares helpful guidelines for getting a program into place to ensure success throughout the lifecycle of a product, from development to market.