Abstract

CRO-Sponsor Collaboration, A Different Way is Possible

Diego Herrera, Head, Almirall S A

There is no reason to be afraid of  CRO-Sponsor collaboration as, it started long time ago in the late 1970s, so this relationship is nothing new. Additionally, CRO and Sponsor are sharing common goals  to promote , conduct, oversight and ensure the compliance of a broad range of  clinical trials type, data sources with  high quality evidence.

CRO-Sponsor evolved over the years because of  continuous  changes  in the company’s  strategies, reorganizations, and growing clinical trials digitalization. The  guidelines/regulations introduced by regulatory authorities have also played an important role in setting up of new services and business models, expanding the CRO-Sponsor collaboration horizon.

Each sponsor must decide the level of oversight that is  right for them  to fit the regulatory demands and internal capabilities. Only avoiding to cross the thin line that separates Study oversight, based on data evidence from  the CRO oversight, Sponsor will not be falling into the  processes or quality controls duplications.

Transparency leads to a better collaboration. CRO-Sponsor should start  early to design common plans for the entire study,  review these plans and patient data dynamically during the study to  ensure final data integrity. Sponsor oversight is not only nice to have , it is actually mandated.

From the Sponsor and Data Management perspective, this presentation will be touching upon ongoing Regulatory and Market initiatives