Over the last several years, significant developments and improvements to regulations regarding pharmacovigilance in drug development have been implemented. However, due to these changes occurring within multiple countries and regions, the pressure now rests on sponsors and marketing authorisation holders (MAHs) to understand and abide by these regulations. One available option for Sponsors looking to overcome this challenge is to outsource different tasks and responsibilities to a Clinical Research Organization (CRO). CRO’s have the ability to provide sponsors (or marketing authorisation holders working on behalf of the sponsor) with a bigger global reach through coverage in multiple countries. They have the knowledge to not only advise sponsors, but also the skills, processes, systems, and resources to be able to adhere to this continually changing and costly environment, while still providing a high-quality service and maintaining compliance.
Sponsors interested in outsourcing different tasks and responsibilities may now see their CRO partners as an extension of their company as opposed to the typical client-contractor relationship. CRO’s have to recognize that each sponsor may have different needs and expectations and therefore appreciate the need to be flexible, while still remaining compliant with all regulations as the ultimate responsibility for pharmacovigilance activities remain with the sponsor. However, the willingness of sponsors to listen to advice from CROs and make informed decisions on best practice means that they remain compliant.
In this article, our safety experts Nick Barker and Katharine Colbert RN, BSN, MSBM, MPH explore several instances where CRO support may be required by Sponsors. You can access the article in its entirety here. You can also learn more about Medpace’s drug safety and pharmacovigilance capabilities here.