TMF and Clinical Operations Quality Excellence

How to think the TMF operations within a broader quality system, assuring that completeness, compliance, integrity of data can be supported thanks to qualified organizational processes aligned with GCP expectations?

The new marcus evans conference “TMF Operations: a Quality and Regulatory Approach” will help clinical operations and documentation professionals to develop better practice and methods to improve safety and performance in clinical trials system while supporting more efficient inspection readiness. With various case studies and discussions platform, this conference will give the opportunity for attendees to boost their practical knowledge and professional experience on quality requirements within trial master plans using a risk based approach and CAPA methods, understanding the new GCP E6 (R2) requirements, discussing continual improvement, featuring electronic transfer, addressing the challenge of fragmented operations and systems with standardized processes. Let’s open the silos and learn from cross functional approach!