The Association of Clinical Research Professionals

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Latest

Managing Financial Risk at the Site Level: Practical Strategies for Underfunded Studies

Many organizations face financial strain as they are asked to support investigator-initiated clinical trials with little or no budget or to absorb hidden costs arising in sponsor studies. Practical strategies are needed to identify and manage this risk at sites, using tools to evaluate feasibility, recover costs and make decisions at the portfolio level. This will enable continued innovation, while building mission-driven research efforts that are likely to gain funding in future.

The Need for Clinical Research Sites to Transition to e-Regulatory Binders: Strategies, Pros, and Cons

Clinical research trials have long relied on paper regulatory binders to manage essential documents required by regulatory authorities, sponsors, and research teams. However, with the increasing complexity of clinical trials, the shift toward electronic regulatory (e-regulatory) binders has become essential to improve efficiency, compliance, and data management.

Measuring Quality in the Age of AI: Why Regulatory Writing Needs a True Standard

The use of generative artificial intelligence (AI) in regulatory medical writing is expanding rapidly, yet the industry still lacks a standardized way to define and measure “quality.” Without measurable baselines, organizations cannot demonstrate whether AI-assisted drafts meet regulatory expectations or improve over time.This article outlines an emerging, multi-layered framework for evaluating AI-generated content in regulatory submissions.
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Events

Atlanta Area Chapter: Streamlining Excellence – Best Practices for Developing Research Site SOPs (ACRP Webinar Replay)

Join the Atlanta Chapter for a virtual ACRP Webinar Replay event. This is event is open to ACRP and chapter members only.

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Kentucky Chapter: Harnessing AI for Patient-Centered Clinical Trial Recruitment

Join the Kentucky Chapter for a virtual educational event.

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ACRP 2026

Join us in Orlando at the premier education and networking event for clinical research professionals.

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