Utilising a Virtual Central Laboratory Approach to Balance the Delivery, Budget and Risk for Clinical Trials
Decentralisation has been one of the biggest outcomes of the COVID-19 pandemic. The speed and degree to which traditional healthcare providers were overwhelmed by the sudden influx of critically ill patients, and the disruption to even local travel, meant that if clinical trials were to continue, they had to adapt, and fast.
Many small to mid-sized pharmaceutical and biotech companies, having adjusted to their own “new normal” day-to-day, are also now realising that there are other options to analysing clinical trials samples than the traditional central lab approach. Ongoing challenges, such as Brexit, driver shortages, the Suez blockade, and potentially dry ice shortages have forced people to adopt a “new normal” to achieve their analytical results.
By decentralising the central laboratory testing for late phase I or phase II clinical trials, milestones can be kept on track and cost effectiveness of the study improved.
Register for this webinar in which featured speakers will discuss:
- Utilising a network of smaller local laboratories for basic safety analysis so that critical data is available to investigators in real time
- Balancing complex laboratory analysis requirements with inflexible laboratory processes
- Navigating rigid laboratory analysis schedules
- Dealing with unanticipated roadblocks
Mike Fudge, Director, Laboratory Services, Simbec-Orion
Mike has 15 years’ experience in the drug development process, predominately in lab operations management, including sample management, across the globe. He has driven business transformation through large and small organisations, defining and managing large programs for lab digitization, lab automation and process optimization.
Dr. Debra Davies, Bioanalytical Manager, Simbec-Orion
Dr. Davies has been leading small to midsize pharma clients through the analytical requirements of GCP clinical trials for over 35 years. She is experienced in developing and running hundreds of methods across a breadth of techniques. Currently, she is heading up innovation and development to transform clients’ requirements into an analytical strategy.
You can learn more about clinical trials by exploring our related posts, like our post on Lupuzor™ Phase III Trials: Partnering With Immupharma.