Webinars

Clinical trials for central nervous system (CNS) conditions have historically been notoriously difficult for a myriad of reasons with a failure rate for new drugs being very high relative to other therapeutic areas. This has caused the industry to think long and hard about remaining or entering this space. Yet the need for novel therapies to slow […]

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 […]

In early clinical development, making changes to a study design after regulatory approval can cause significant delays. These can be avoided by incorporating additional/optional study parts into the original protocol. Proactively planning for additional study elements gives greater flexibility, allowing you to make decisions based on emerging data, without requiring additional regulatory approval. With extensive practical […]

This 1-hour webinar reviews a published consensus statement from the British Journal of Cancer (BJC), looking at recommendations for effective delivery of Complex Innovative Design (CID) cancer trials. The traditional cancer drug development pathway is being superseded by trials that address multiple clinical questions. CID trials not only assess the safety and toxicity of novel […]

In this webinar members of our specialist, early phase Project Management team discuss how they tackled the range of challenges faced in clinical development to successfully execute a variety of Phase I clinical studies in patient populations. Explore our related webinar: Accelerate Early Clinical Development with Adaptive, Multi-Part, First-in-Human Study Design.

In this webinar the speakers discuss the use of integrated protocols (umbrella protocols) to maximise programme efficiency. In addition, key aspects of the revised EMA First-in-Human guidance will be considered in order to design suitably-flexible protocols to avoid unnecessary regulatory delays. Pros and cons of conducting early phase research in the EU will also be discussed, […]