Ram Sathia

Industry Perspective: Finding the Missing Link Between Clinical Trial Interoperability and Operational Excellence

Blog

Clinical trial interoperability has evolved beyond a technology integration initiative. It has become an operational priority that influences study execution, data quality, regulatory readiness, and decision-making across the clinical development lifecycle. As organizations seek to modernize their clinical platforms, engineering delivery models are also evolving to support closer alignment between technology implementation and business outcomes. Forward Deployed Engineering is emerging as one such delivery model.

ACRP CEO Recognized as 2026 Nashville Titan 100 Honoree

News

David Vulcano, FACRP, Chief Executive Officer at ACRP, has been recognized as an honoree of the 2026 Nashville Titan 100, a program which recognizes Nashville’s top 100 CEOs & C-level executives. The honorees are the area’s most accomplished business leaders in their industry, using criteria that include demonstrating exceptional leadership, vision, passion, and influence in their field.

A Visit with Toni Willis, Public Member of ACRP’s Board of Trustees

Blog

Did you know that the ACRP Board of Trustees includes a public member whose role is to champion the public or consumer interest in the drug and device research and development enterprise? They are chosen to bring new ideas and goals to the table, contribute an unbiased perspective, encourage consumer-oriented positions, and offer additional public accountability and responsiveness. We asked Toni Willis, MD, FAAPMR, the current ACRP Public Member, to share some background on her career and how she came to serve in this volunteer role.

Bridging the Monitoring Gap: A Structured Framework for Clinical Quality Management

Clinical Researcher

Independent oversight of research conduct is essential to protect human subjects’ rights and welfare, educate investigators on ethical practices, enhance the ethical review process, safeguard institutions from federal regulatory actions, and maintain public trust in medical research ethics committees. Routine monitoring activities ensure studies are being carried out as intended, while prioritizing the health and safety of the participants. However, federal and foundation-funded projects may not have built-in processes for routine monitoring. To address this gap, Duke University created the Clinical Quality Management Program, which provides a robust framework for clinical research studies, including policies, procedures, and tools that allow clinical research units to effectively monitor without external oversight.

Navigating Protocol Amendments: Understanding the Growing Burden and Charting a Path Forward

Clinical Researcher

Protocol amendments have evolved from an expected operational reality to a defining factor in clinical trial performance, cost, and site sustainability. Across sponsor, contract research organization, and site stakeholders, a consistent message is emerging: while amendments are often necessary, their frequency, timing, and execution are introducing significant downstream inefficiencies. The evidence is clear: protocol amendments are now a system-level challenge requiring coordinated, industry-wide solutions.