Developing biomarkers is key to delivering medicines that improve patient’s lives. Good biomarkers have the potential to confirm that the compound/study drug affects the intended biological pathway and confirm the mechanism of action and help with dose setting. Novel biomarker assays are developed by the sponsor and transferred to a performing qualified lab to have a fully qualified assay for a global clinical trial. Partnering between the sponsor, the CRO managing the trial, and the central lab to successfully meet timeline deliverables is a well-orchestrated production requiring open communication and flexibility.

Labconnect continues to lead the industry in providing innovative strategies and solutions to the ever growing complexities of clinical trial virtual sample management. The complexities of sample collection and logistics in advanced therapy studies naturally brings chain of custody challenges in protecting the integrity of a trials’ high value samples. Topics will include end to end sample management strategies, logistical integration planning, real-time tracking and LIVE monitoring technologies.

Outsourcing your biospecimens is a major decision but maybe the easiest decision in the whole process. Choosing a company to handle, track, and potentially process invaluable specimens as well as aggregate usable data can be a complicated process. This discussion will outline some of the items a company should consider when using an outside entity to manage biospecimens and their associated consents.

COVID-19 interrupted clinical trials globally and presented our industry with the challenge of continuing clinical research while ensuring patient safety and data integrity.  Cerevel Therapeutics analyzed ongoing trials to identify risks and implemented innovative solutions to meet those challenges, collaborating with a wide range of service providers to create a hybrid approach which supports patient needs, data requirements and site operations.   

The Decentralized Trials & Research Alliance enables collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research.

This past year has led to buzzword overload! In this session, we will cut through the buzzwords and learn about the realities of eSource/direct data capture (DDC) and how the use of this approach, although not new, can be applied to your clinical trial challenges that have become more prominent in our COVID world. 

Armed with laptops, VPN's, tokens, and a million different end points to log in to, clinical trials have gone digital forcing us to become more creative in how we manage technology; a necessary evil in decentralizing our trials.  As we adapt to the new norm, let's talk about some strategies to eliminate the noise of technology.

Today’s decentralized and virtual trials require a shift to direct-to-patient (DTP) distribution to keep trials moving forward. Join us to explore opportunities to optimize a supply chain strategy that accommodates both direct-to-site and direct-to-patient services utilizing a global Good Manufacturing Practices (GMP) depot network along with DTP and direct-from-patient (DFP) services

The Janssen Global Development Feasibility team has built a sustainable global model to support every trial with data science and technology at an industrial scale. This presentation will focus on briefly showcasing several tools and algorithms that were built internally to bring unfathomable value and data-driven solutions to trial teams that aids them in making solid decisions on how to operationalize each trial for ultimate success and decreased patient and site burden.