Myrthe Trompert
Salvius Legal B.V., Zeist, The Netherlands
Title: The importance of solid contract management for Biopharmaceutical and Biosimilar companies conducting Clinical Trials in Europe
Biography
Biography: Myrthe Trompert
Abstract
Further to recent changes in laws and regulations, a sponsor of a clinical trial is increasingly made accountable to ensure compliance and oversight of its clinical trials. The new ICH E6 R2 GCP guideline, but for instance also the new General Data Protection Regulation, have increased the responsibilities and obligations of a clinical trial sponsor.
Since many different stakeholders are involved in the conduct of a clinical trial, it can be quite a challenge for a sponsor to maintain control over the conduct of its clinical trial. In addition, in order to avoid other risks when conducting a clinical trial – such as delays, damages or loss of profit – it is important for a sponsor to build a solid foundation for the collaboration between the different stakeholders.
For the above reasons, it is of crucial importance to set up a solid contractual framework and contract management process for each clinical trial. This requires knowledge on international and country-specific laws and regulations, but also requires insight in the roles, responsibilities and risk posititions of the different parties that are involved in the clinical trial, such as Contract Research Organizations, vendors and investigational sites. The presenter will discuss important considerations in this respect.