Decentralized clinical trials (DCTs) offer multiple benefits including enhanced patient experience, high quality data and the agility to manage disruptions, e.g. COVID19 pandemic. Implementing an effective decentralized solution requires a robust RBQM process that allows early identification of risk and centralized monitoring can be a key component of a decentralized design to inform timely decision making. This presentation will discuss case studies and risk analytics for successful management of DCTs.

Sponsor organizations must oversee the execution of trials when those are outsourced to CROs. This includes oversight of risk-based quality management strategies. This may be somewhat challenging in full-service outsourcing models when CROs are using their own procedures, tools, and processes. The presentation will include key risks to RBQM planning and execution in outsourced models and oversight model that may be applied to mitigate the risks. 

Central Monitoring has been encouraged since ICH E6 (R2) in 2016, but adoption has been slower than anticipated.  Obstacles to implementation include access to data, data format and standards, cost and complexity of analytical tools to visualize data, integration into clinical monitoring process, where in the organizational structure central monitoring is best aligned and what skillsets are needed for those primarily responsible for conducting the analyses.  Establishing a few guiding principles can help overcome these challenges resulting in greater adoption and successful return on investments.  This session will explore one organization’s strategy and lessons learned.  

Striving to do high quality work is a good trait, especially for clinical trials. MSD will share a story from the past, how they got SMART and why they now focus on what matters by embracing a risk-based approach to the management of protocol deviations.

Your monitoring process includes a combination of centralized, remote and onsite monitoring of your clinical trials. Have you updated the metrics that you are using to oversee the new integrated process? Are you using the right KRIs? Are identified risks turning out to be actual issues? Are your monitors focusing on the most important risks and issues? Are site issues being addressed? These are questions that a multi-stakeholder group has been exploring at an industry consortium. Find out about the approach, the challenges, and some of the new monitoring metrics developed by the group.

The global pandemic challenged us all to think outside of the box. The pandemic has offered auditors a way to adapt successfully and to evolve our methodologies. Through innovative thinking and increased use of technology, we have taken audits from onsite to a more virtual approach. A remote audit ensures involvement with investigational site staff with key source data review while a Hybrid audit includes a limited onsite portion with the involvement of an eyes and ears role. This evolution has shown the delivery of high-quality audits that will offer sustainable options for audit conduct now and for the future.

Many sponsors face important operational challenges when they  split monitoring in blind and unblinded roles. You need two teams  with the impact on cost and resources but you also increase the operational risk of unblinding the blind team. Your systems may not be ready to build a firewall. Human error plays a role too and suddenly you end up managing several quality issues related to unintentional unblinding. After attempts of  adjusting  processes, MSD rolled out a new innovative and flexible  operating model in collaboration with a CRO partner, enabling us full oversight and control, minimizing the risks.

RBM is now incorporated as a GCP expectation in most ICH regions and  by regulatory agencies. Sponsors are accountable to ensure proper oversight of the execution when activities are outsourced to CROs. In addition, the COVID-19 pandemic showed the importance of centralized, data-driven sponsor oversight to ensure patient safety and high-quality clinical trial data. This session will explore Merck KGaA’s strategy on sponsor oversight.