EHR Optimization and Decentralized Strategies for Clinical Performance Studies of Liquid Biopsy Technologies in Cancer Screening

The adoption of hybrid and fully decentralized clinical studies is transforming the landscape of clinical research for liquid biopsy diagnostics, particularly in cancer screening.

As clinical research evolves, the ability to identify and engage diverse populations, manage logistics for specimen collection, acquire imaging and pathology data and adhere to lab analysis protocols becomes critical. Conducting decentralized studies of in-vitro diagnostic (IVD) products requires a technical and pragmatic understanding of the instruments, vendor limitations and requirements and human factors that contribute to success.

In this webinar, the expert speakers will share their deep knowledge and real-world experience in deploying decentralized strategies for validation and clinical performance studies. They will discuss proven methods for streamlining data collection and study management virtually while ensuring data integrity and regulatory compliance. The key topics will include:

• Digital recruitment techniques, including electronic health record (EHR) optimization, to identify, educate and consent diverse patient populations, particularly for underserved communities
• Remote specimen collection and logistics
• Retrieval of medical records as well as supporting imaging and pathology data
• Retention strategies for longitudinal designs, engaging participants over extended study periods, including EHR, optimization robust data sets

Join this webinar to learn how to optimize patient identification and diversity focused recruitment utilizing EHR and digital outreach strategies, utilize and manage third party vendors remotely and ensure successful, diverse patient participation.

Speakers

Dr. Faith Holmes, Chief Medical Officer, Elligo Health Research®

Dr. Faith Holmes brings more than 30 years of experience in direct patient care and 11 years of medical practice management, with a diverse background in Family Medicine and Palliative Care spanning the continuum of the patient journey.

As Elligo’s Chief Medical Officer, Dr. Holmes is integrally involved in the conduct of studies at Elligo’s Clinical Research Center as well as those utilizing Elligo’s hybrid or decentralized solutions. She has served as the Principal Investigator for much of the latter, including interventional and observational studies of diagnostic devices for early detection of various cancers.

She earned her BS in Chemistry and Biology from Trevecca University, her MD from ORU School of Medicine and is board-certified in Family Medicine and Hospice and Palliative Medicine.

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Chris Pepper, Senior Director, Medtech and IVD, Elligo Health Research®

Chris Pepper is a seasoned business leader and strategist with over 12 years of experience in medical device and diagnostic research. Chris has proven success in building solutions that help clients acquire imaging, biosensor and diagnostic data to support outcomes in clinical studies.

As Senior Director of Medtech and IVD Strategy at Elligo, he oversees relationships with Elligo’s IVD and digital health clients, device-focused CRO partners and works with executive leadership at Elligo to identify tools and vendors to streamline the execution of diagnostic studies conducted virtually or within the Elligo site network.

Chris is an active member of the Association for Diagnostics & Laboratory Medicine and the European Society of Radiology. His experience prior to Elligo includes establishing the Life Sciences division of Arterys prior to it being acquired by Tempus Lab, and business leadership roles with several device focused CROs and core labs, including ICON, IQVIA, NAMSA, & Medical Metrics.

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Nicole Cowan, IVD Operational Consultant, The Collective Healing, LLC

Nicole Cowan is a senior leader with extensive experience in strategic planning, clinical trial execution and the commercialization of in vitro diagnostics (IVD). As an IVD Operational & Strategic Consultant, she advises IVD Manufacturers on design, execution and compliance considerations for their clinical studies through her consultancy The Collective Healing, LLC.

Nicole has held senior leadership positions and successfully built the IVD Programs for ICON and IQVIA where she was responsible for managing operations across North America, EMEA and APAC.

Nicole has over 13 years direct patient care experience and over fifteen years’ industry experience directing and managing global feasibility, pivotal and post–market studies. Cowan obtained an MSc in Molecular Biology & Microbiology at the University of Central Florida’s College of Medicine (UCF COM), with focus in neurodegenerative disease and infectious disease.

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