Clinical Research Systems and ROI: Cumulative Burdens Tip the Scales in Favor of Integration

Clinical Researcher—November 2020 (Volume 34, Issue 9) GOOD MANAGEMENT PRACTICE Erin L. Pennington   Clinical trial management systems (CTMSs) and electronic institutional review board (eIRB) systems have been staples in the information technology (IT) landscape of research organizations and supporting the operations for clinical trials and local IRB offices for more than a decade. Despite […]

Harnessing the Workforce the Public Deserves

Clinical Researcher—November 2020 (Volume 34, Issue 9) EXECUTIVE DIRECTOR’S MESSAGE Jim Kremidas   This month’s issue of Clinical Researcher focuses on one of my favorite topics: the clinical trial workforce. You, the members of ACRP, are the foundation for vital work promoting health and prolonging life. The COVID-19 pandemic has more than merely reinforced the […]

Patient-First Approach Enables Home-Based Support During Orphan and Rare Disorder Studies in Pandemic Conditions and Beyond

Clinical Researcher—November 2020 (Volume 34, Issue 9) RECRUITMENT & RETENTION Donovan Quill   Thirty million Americans live with a range of 7,000 rare or orphan diseases, and while many affected patients have struggled with reduced care, isolation, and adherence issues for most of their lives, the issue of self-isolation during the COVID-19 pandemic has […]

How PBPK Modeling Can Replace Drug-Drug Interaction Studies

Clinical Researcher—November 2020 (Volume 34, Issue 9) REGULATORY COMPLIANCE Karen Rowland Yeo, PhD   Patients often take more than one drug at a time, especially elderly patients and those with complex diseases, such as cancer and neurological disorders. Therefore, it is crucial to determine what the potential risk might be of a new drug candidate […]