In early November the Pharmaceutical Business Conference Group hosted the inaugural COG West Coast meeting in Burlingame, California. Todd Reul, Clinical Outsourcing Leader at Pfizer, presented on leveraging CROs/ Vendors in clinical studies.
The presentation reflected Todd Reul's personal experiences and opinions, not the views of Pfizer. He has over 30 years of experience working in clinical operations at companies of varying sizes.
Key takeaways from Todd's presentation:
Small to mid-size companies often use an "Under One Roof" outsourcing model, relying on a CRO to provide and manage all services. Larger companies use a "Best in Class" model with specialized vendors. The business burden on internal staff should drive the model.
More vendors equals more workload for sponsor staff around contracting, vendor management, meetings, issue resolution etc. This can detract from critical enrollment and site engagement work.
"Best in Class" allows sponsors to contract directly with niche experts, maximizing quality and leverage. Dedicated vendor management staff helps minimize the burden.
Strong partnerships, open communication, thoughtfully empowering vendors, sharing long-term plans, and not over-indexing on costs creates win-win relationships.
Performance metrics and executive issue escalation keeps all parties focused and accountable. The solution matters more than finding blame.
Carefully evaluating business bandwidth, building trusting partnerships beyond a single study, leveraging niche experts, and maintaining transparent expectations are key to maximizing the value of clinical outsourcing.