eClinical Articles

  1. Developing A Risk-Based Model For Computer System Validation 9/11/2025

    Consultant Richie Siconolfi explores risk factors that can be used to develop a risk-based approach to computer system validation.

  2. The Dream Is EHR-To-EDC — eSource Is The Wake-Up Call 9/11/2025

    EHR-to-EDC integration promises efficiency but struggles with interoperability, compliance, and site adoption. eSource emerges as the real bridge, with case studies like MSK proving it can cut setup times, boost accuracy, and lighten site workload.

  3. 3 FDA Guidance Documents That Shaped Today's Computer System Validation 9/10/2025

    Consultant Richie Siconolfi outlines three FDA guidance documents for evaluating and mitigating risks in validating computerized systems.

  4. Ask An Expert Before Shredding Your Mobile Device CAPEX 8/14/2025

    Tasked with buying your company's mobile devices and not sure where to start? Discover the questions you should ask and the information you need to know before consulting an expert.

  5. The Placeholder Debate: Why Teams Love (And Hate) This TMF Tool 7/7/2025

    What is an eTMF placeholder? Why do some love it and some hate it? ICE Consulting's Suzanne Turner explains why there's such debate over their usefulness.

  6. Integrating QMS And eTMF For Proactive Clinical Trial Quality 6/24/2025

    In today’s clinical trial landscape, where complexity is the new challenge, integration is not optional: QMS defines quality, and eTMF proves it. 

  7. The Risks Of AI In Clinical Research From A Trial Management Perspective 4/9/2025

    In part two of this series, consultant Donatella Ballerini explores the challenges of integrating AI into eTMF management and how to mitigate them.

  8. How AI Models Can Actually Improve eTMF Management 4/8/2025

    GCP consultant Donatella Ballerini explores how AI is shaping eTMF management and what this means for the future of clinical research in part one of this series.

  9. eClinical Solutions Market To Double In 5 Years, As Sponsors Prioritize Efficiency 4/4/2025

    The global eClinical solutions market is projected to reach $22.1 billion in 2029, double its presence in 2024. Experts discuss the specific solutions driving market growth and share how they impact clinical operations.

  10. Is Double Programming Really Required For Validation? 3/10/2025

    Double programming has been the gold standard for validation, but technological advancements and improved sponsor oversight of CRO deliverables have introduced more efficient and reliable alternatives.