Decentralized Clinical Trials: Best Practices for Designing a Flexible, Resilient Protocol

As drug development sponsors are incorporating patient-centric elements into their traditional clinical trial designs, there are several factors to consider during the study planning phase. Whether using telemedicine, mobile nursing services, laboratory support, patient service centers, investigational product management, or a combination of these elements, it is important to develop an operational strategy that allows for flexibility and accounts for complete oversight of each connection point between patients, service providers and the sponsor.

Join this educational webinar to learn best practices for designing a customizable protocol centered around leveraging technology to reduce patient and site burden, streamline data collection and endpoint analysis and optimize study design to support study continuity. Through lessons learned during the global pandemic, the speakers will discuss how to quickly accommodate today’s current studies to function in a decentralized model.

This webinar will also discuss lessons learned for planning ahead to seamlessly apply this approach for future trials. By walking through several real-life examples and providing innovative solutions to traditional schedule of assessments to create operationally sound decentralized clinical trials, the speakers will share insights for operational planning, management of integrated technologies and change management to better equip sponsors with the tools and resources to design a more flexible and resilient protocol focused on patient-centric solutions.

Speakers

Susan Foose, Associate Director, Decentralized Clinical Trials, Covance

Susan Foose is a clinical trial professional with over 17 years of experience in drug development on both the CRO and vendor side. Over her career, Foose has been involved in many aspects of clinical drug development from clinical operations to project management. She most recently joined the Decentralized Clinical Team in 2018 after three years in Covance’s Management Development Program.

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Cristina Green, Executive Director, Decentralized Clinical Trials, Covance

Cristina Green is a clinical trial executive with over 23 years of experience in drug development at Covance. Over the course of her career, Green has overseen trials and led teams across data management, project management and clinical operations. She joined the Decentralized Clinical Team in 2017 after leading the Clinical Operations function for North America for four and a half years and then Latin America for two years. In her current role, Green works closely with sponsors on their strategic plans for decentralized clinical trials across their portfolio of studies.

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Jane Myles, Director, Decentralized Trials Implementation, Covance

Jane Myles is a clinical operations expert and clinical trials innovator, with a background as a pharmacologist and toxicologist. She has extensive experience working globally across late stage portfolios and helps drive innovation into the design and execution of trials to get medicines to patients faster and to decrease the burden on patients and sites. She has worked directly with pharmaceutical companies in global trial management roles and as an operational program leader. Myles contributed to the development and approval of many life-changing medications including Rituxan, Tarceva and Gazyva.

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