Heike Schoen
LUMIS International GmbH, Berlin, Germany
Title: Effective oversight management in clinical trials
Biography
Biography: Heike Schoen
Abstract
The implementation of the new ICH E6 R2 GCP guideline has created confusion, contradictory opinions about what is necessary to be implemented as Sponsor oversight in clinical trials to fulfill the requirements. Sponsor oversight in general is not new, of cause, but the details to mandatory perform oversight activities and to manage compliance for all clinical trial activities have raised lots of discussions with different opinions and solutions.
One important activity for Sponsors is to define and implement tools for effective oversight management of their clinical trials, to implement a risk based clinical quality management sytem and to train the clinical development teams.
During the session we will explain the different steps needed to implement an effective oversight quality management system covering the following topics in more details and with case studies:
- Defining a risk based quality management system
- Early implementation of tools for clinical trial oversight management (e.g., through key performance indicators)
- Effective communication with all stakeholders
With an early investment in the beginning of a clinical trial or program and with careful planning and team education sponsors will be able to perfrom successful risk based oversight management and to keep the required balance between oversight and „micromanagement“ and most important to keep balance with the budget.