Digital capabilities including remote monitoring, electronic patient-reported outcomes, and wearable sensors, are enabling clinical trial decentralization at scale. Robust DCT execution requires proactive, scalable central monitoring strategies to interrogate data at point of capture, minimize study risk, and provide continuous oversight of data integration, flow, and quality. This session explores how DCTs have evolved and elevated RBQM strategies towards the new normal for clinical operations.

In 2020, a top-three pharma company successfully implemented a remote monitoring and source data verification program for their COVID vaccine studies. This program made remote access available for 60 active studies across 2,800 sites in just one year. During our presentation, we'll show you how the organization implemented their remote strategy, what the strategy currently looks like, and how it's helped their business.

Lokavant is a clinical trial intelligence company, capturing emergent insights for sponsors and CROs through its integrated product platform. Our scientists mined data from > 2,000 trials to identify factors that predict patient discontinuation. Discontinuation poses a major challenge for trials because patients may be non-evaluable – reducing power on endpoints and leading to longer, more expensive trials. Join us for a tour through our research and what we do at Lokavant!

Although risk-based monitoring is no longer considered a new way of working, it continues to stay an area that is constantly evolving. Changes in landscape due to the pandemic are accelerating this evolution. During this session we will share how risk management and data analytics can be leveraged to monitor quality and patient safety in clinical trials where innovative solutions and processes are being used.

Your organization outsources centralized, remote and onsite monitoring to your CRO … how do you oversee the new monitoring process?  Who selects the KRIs? Are they the right KRIs? Are identified risks becoming actual issues? Are monitors focusing on the most important risks and issues? Are site issues being addressed?  A multi-stakeholder group has been exploring these questions. Come hear about new monitoring metrics developed by the consortium.

In many organizations specialized roles and teams to facilitate Risk-based Quality Management are created. I will summarize 10 years of my experience in creation, recruitment, and development of CM/RbQM teams. I will share examples of recruitment process tasks and cases aiming to confirm the desired skills and we will look at an exercise aiming to "brake" the simplest trial ever designed.

As clinical trials become more complex, the importance of managing quality from study startup to submission cannot be overstated. In this session, you’ll learn how to leverage artificial intelligence and machine learning for more efficient, effective, and transparent remote monitoring, risk detection, Source Data Review, and Source Data Verification

As a mid-sized sponsor company grows, how can one start to build systems and processes for risk-based study execution that are right-sized for the organization but can adapt and flex for future growth?  This session will take a look at the systems, roles, and CRO partnership model(s) that Alkermes’ Clinical Data Operations team are building from the ground up to position the organization for current and continued success. 

Highly trained HCPs are essential to ensuring the quality and integrity of data collected during in-home patient visits. By selecting HCPs who are appropriately medically trained, data will be more accurate, thus decreasing the time required to monitor the data - which will improve quality management and source data verification strategies for sponsors and CROs. This presentation will review important factors to consider when selecting HCPs for mobile health patient visits.

Remote monitoring in clinical trials has been an acceptable standard for several years now, but with the onset of the COVID-19 pandemic, the need to remotely monitor clinical data has become a necessity. When remote monitoring isn't a familiarity within your organization, how do you devise the appropriate steps to move forward? This talk will discuss steps taken to efficiently create a remote monitoring plan for your team.

This presentation will review applicable regulatory guidelines for monitoring of clinical trials in state of emergency, data integrity/quality expectations; provide an overview of FDA's remote inspections findings and review trends; share best practices for remote monitoring and alignment of policies/procedures between stakeholders, and provide insights into contracts/budgets amendments for remote versus on site monitoring.