Contemporary clinical trial management in an academic medical center

Clinical trials require an enormous investment of time, money, and precious resources such as subject participation and research staff labor. The stakes are very high, and outcomes depend critically in equal measures on proper management of the biosamples and clinical data associated with each participant. It is therefore essential for the clinical trial team to have at its core a structure that allows for seamless integration of these processes from the earliest stages of trial design. Establishment of collaborations between biobanks with sample processing capabilities and clinical trial centers, academic or commercial, play a central role in achieving this goal. These presentations will highlight one such partnership between the clinical team at Rutgers University and the SMART labs at Sampled.

A Clinical Trials Office offers a unique platform for clinical trials execution in an Academic Medical Center (AMC) operating during and after the COVID-19 pandemic. The power of Electronic Medical Record (EMR) mining has enabled a paradigm shift to support the recruitment of participants into clinical trials and enable minimal touch trials in AMCs. This change was driven by two factors; advancements in how AMCs and their service partners leverage and use EMR data, and operational adaptation due to the COVID-19 pandemic.

Key learning objectives

• How COVID-19 has changed the landscape for performing clinical trials
• The role played by EMR mining in recruiting participants into clinical trials
• The challenges facing minimal-touch clinical trials in AMCs

Who should attend?

• Clinical Trial Operations Managers/Directors/VP
• Clinical Research Associates/Managers/Directors
• Clinical Trial Project Managers/Directors
• Clinical Quality Assurance/Regulatory Affairs Managers/Directors
• Biostatistics Specialists
• Clinical Trial Sponsors

Certificate of attendance
All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.