Join us at COG UK 2025, where innovation and collaboration in clinical research take center stage! We’re excited to showcase our latest solutions and share insights on enhancing trial efficiency, data safety, and patient engagement. Join us for a presentation on safeguarding your data and connect with our expert team. We can’t wait to see you there!

Avoiding Pitfalls When Outsourcing Safety in Clinical Trials: Safeguarding Your Most Sensitive Clinical Data
Lee McGuinness, Vice President, Pharmacovigilance and Materiovigilance, Premier Research
2:30-3:00 p.m., 4 March, Stream A – Clinical Outsourcing Confusion

When outsourcing safety management activities to a contract research organization (CRO) or other external provider for products in development, a meticulous and strategic approach is essential. The selection process must be guided by a comprehensive evaluation of the provider’s expertise, technological capabilities, regulatory knowledge, and operational reliability, while also ensuring that the provider is a good fit for your organization.

This presentation will explore the critical factors for assessing PV providers, highlighting common challenges that can compromise the success of outsourcing initiatives. Attendees will gain valuable insights into the benefits of outsourcing PV, including enhanced efficiency and scalability, while emphasizing the importance of transparent communication among stakeholders. The discussion will also cover the role of technological advancements in streamlining operations and strengthening regulatory intelligence to improve submission quality and compliance.