As experienced pharmaceutical industry executive Mo Ali settled into his volunteer duties as Chair of the ACRP Board of Trustees for 2026, a year in which the Association celebrates its 50th anniversary of service to its members and stakeholders, he took time to answer some questions about his experience in the clinical research enterprise, some of the challenges and opportunities facing it, and how ACRP can further its mission in a time of rapidly evolving technologies and processes.
The Health Care Compliance Association’s 30th Annual Compliance Institute (CI), taking place April 27–30, 2026, in Orlando or virtually, offers practical tools and insights to support this work.
In this article, the authors explore how clinical research professionals can alter their approach to developing informed consent documents and use both existing resources and incremental change to better serve research participants. They also describe how a small team developed a toolkit composed of visual aids, study visit schedule templates, risk-communication graphics, language repositories, and supplementary guidance documents with the goal of improving informed consent documents and participant understanding.
This article explores strategies to improve study start-up efficiency, including best practices in site feasibility, regulatory submissions, contract negotiations, and communication. It also examines the use of performance metrics, parallel processing, and technology-driven solutions to accelerate trial initiation without compromising quality.
The goal of the revised ICH E6(R3) guideline for Good Clinical Practice is to drive stronger governance, continuous quality advancement, and consistent study collaboration globally. To meet the new expectations, sponsors, sites, and contract research organizations should consider revising procedures, systems, and training programs for proactive oversight.