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.
Who Should Attend?
- Clinical drug developers
- Pharma companies
What You Will Learn
Join this webinar to learn how strategic selection of central laboratory service providers and local laboratories can simplify the critical safety analysis pathways by:
- Saving time
- Reducing budget
- Increasing the ability to navigate unanticipated difficulties
Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Simbec-Orion offers clients a full spectrum of drug development services from first-in-human Phase I clinical studies through to pivotal Phase III studies and Phase IV post-marketing studies. With a focus on tailormade and scalable solutions, Simbec-Orion adapt delivery style, communications and operations to suit the demands of your project, helping you achieve your clinical and commercial objectives.