Developing Robust Clinical Trial Protocols through Standardization of Data Driven Risk Assessment Models, Adequate CRO Oversight & Proper Documentation Practices to Match Regulatory Expectations & Ensure Quality by Design throughout the Clinical Trial Process
As risk based monitoring emerges as a primary tool used by quality teams to develop clinical trials, the lack of standardized models, difficulty with CRO oversight, and documentation inaccuracies have made the adoption of this risk based approach challenging. Regulatory authorities have indicated an allowance for more risk monitoring throughout clinical trials as auditing methodologies become less of a focus, but teams must ensure the employed methodology is data driven and supportive of future filings and submissions. Reduced clinical team cooperation and shortage of technical experience in risk management has made it difficult for quality professionals that aim to match regulatory expectations and guarantee adherence to protocol throughout pharmaceutical trials.
The Risk Based Clinical Quality Assurance Conference will address the concerns surrounding implementation of risk monitoring by bringing together clinical research professionals, regulatory authorities and risk management experts to examine approaches for a successful clinical trial process. Sessions will be presented by clinical experts who have successfully built strategies for thorough CRO oversight, comprehensive documentation protocols, and the development of standardized models for risk assessment. Through concrete case study examples and open panel discussions between industry leaders, this program will support clinical quality teams that prioritize clinical trial success and align methodologies with the latest guidance from regulatory authorities.