We apply a common framework to assess the quality of recruitment decisions and identify common issues leading to deviations from plan. Although the recruitment problem can be framed clearly and clinical teams come up with innovative alternatives, recruitment predictions may suffer from lack of relevant insights or plans may not be aligned with operational objectives. Even if we apply a sound rationale to come up with the best plan, we would need commitment from various groups to execute on it. Investigation of the decision quality elements has potential to maximize our learnings from the past.

When facing a global pandemic, we needed to rapidly develop scenarios and generate risk assessments and strategies to serve our subjects and patients under care in our clinical trials.  Understanding the relationship between global trial sites and Covid-19 hotspots allowed us to focus our resources in critical regions and on specific issues that had the potential to affect our ability to provide continuous support to our participants and sites worldwide.  

The COVID-19 pandemic has resulted in a significant acceleration in the industry’s adoption of RBQM core principles over the past year.   This has brought with it an ever-increasing body of evidence confirming the effectiveness and high value that this new paradigm offers.  This presentation will provide a summary of this compelling evidence including recent use cases and relevant metrics, along with a review of best practices associated with RBQM success.

Metrics measure performance and progress, but also can tell a story and give a sense of direction. Despite being in the pharma space for a while,  RBM remains an evolving area. It is rapidly changing – so do metrics. Many established functions were going down the same path: user experience, risk management, project management, quality and some others. This presentation is an attempt to leverage their experience and benchmark with the current RBM metrics portfolio.

In context of Covid-19 pandemic Janssen has developed a QTL dashboard focused specifically on missed critical data (endpoint, safety) potentially impacting ongoing studies’ validity. Setting up QTLs, and monitoring across several studies at once, allowed gathering robust experience and mobilized organizational learning of QTLs. The experiences are also used for development and implementation of full QTL process in Janssen.

The TransCelerate QMS and RBM initiatives can help sponsors lay a foundation for risk-based quality management (RBQM). Implemented holistically, RBQM can increase the resilience of the clinical research environment during crisis situations, e.g. COVID-19. Essential feedback loops provide insight on how components are performing. Potential problem areas are identified via risk management plans and data collection. Response to quality signals can be addressed in study level risk management plans.

The rise of a highly-contagious COVID-19 variant has highlighted the importance of developing vaccines that induce broadly reactive antibodies capable of offering potential for protection from mutated strains of COVID-19 that may continue to emerge over time. The challenge the industry is facing is not only prioritizing how to end the ongoing pandemic, but also how to optimize vaccines for long-term protection against coronaviruses. With the goal of developing vaccines that add meaningful clinical benefit to the group already approved, VBI is progressing two vaccine candidates – a monovalent COVID-19 candidate and a trivalent broad-spectrum coronavirus candidate, which in preclinical studies induced reactive antibodies against COVID-19, SARS, MERS, and a seasonal variant HCoV-OC43. 

The ICH (GCP) renovation covers both ICH E8 and  ICH E6 R3. This presentation takes an holistic view of the changes as well as the benefits that everyone involved with pharmaceutical development (sponsors and CROs) Will receive. But to achieve the benefits that come from QbD a holistic approach to QbD, via risk management and QTLs must be taken.

One of the pillars to a successful trial is data management. The data management workflows have been manual in many aspects including review, cleaning, oversight and reporting heavily reliant on Excel. RBQM concepts, including quality by design, risk-based approaches, automation and aggregation, and transparent reporting can be applied to these workflows, bringing substantial improvement to processes, collaboration and oversight.

As we entered a new normal at the tail end of COVID-19, we took lessons learned from the experience and applied them to how we continue to conduct clinical trials to produce new therapies for the patients we serve. We needed to look beyond the pandemic to design and plan resilient clinical trials with the ability to withstand future pandemics and mitigate some of these key challenges. During this session, the panel will discuss some of the ways we examined and implemented a better way to do clinical trials from concept through conclusion. 

Founded in 2006, Highthinkmed is the fastest growing clinical CRO in China with over 800 full time employees, providing one-stop clinical services including clinical operation, medical affairs, data management, biostatistics, pharmacovigilance, regulatory affairs etc. Highthinkmed owes its own eCTD system meeting requirements of FDA, EMA and NMPA with a professional team providing eCTD submission services. Highthinkmed welcomes all partners across the world for international collaboration.

Cmed Technology CTO, Dr. Tim Corbett-Clark shares his views on the current landscape within clinical trials, discussing the challenges that point and unified solutions bring. He also examines how to best optimize clinical trial data workflows by bringing the tech to data, removing the silos, and eliminating the barriers to getting holistic data for total control and visibility from phase one to four.