Data Monitoring and Clinical Endpoint Committees
We provide guidance in the organization and management of independent data review committees suitable to your data evaluation needs. Whether you require the formation of a Steering Committee, Data Safety Monitoring Board or Clinical Endpoint Committee, our expertise will ensure this pivotal review is conducted in the strictest confidence and with the highest quality of support from our team.
We understand the sensitivity of these reviews and the impact they have on your study, your program portfolio, and your product's future development. We are committed to clinical trial data veracity.
The use of Data Safety Monitoring Boards is compelling when randomized multicenter studies investigating high-risk, novel drugs may require the evaluation of mortality or efficacy endpoints at an interim review of the trial. We collaborate with our clients in the interim review design to optimize the informational value of the clinical trial data and control associated costs.
Data Monitoring Core Services:
- Charter Development
- Meeting Coordination/Facilitation
- Data Analysis and Preparation of Listings, Tables and Figures
- Independent Biostatistician and Team