Clinical Trial Compliance & Operations Tech Articles

  1. What Sites Wish Tech Vendors (And Sponsors) Heard At SCDM But Probably Didn't 10/8/2025

    During a Society for Clinical Data Management (SCDM) panel discussion, three site-side representatives discussed the challenges clinical research coordinators have executing their clinical duties amid increasingly complex data entry demands.

  2. SCDM 2025: Practical Advice From Global Regulators — Including The FDA 10/6/2025

    Discover what regulators from around the world, including the FDA, think should be top of mind for clinical data managers.

  3. Powering Standards With Code: The Role Of Open Source In CDISC 360i 9/26/2025

    Discover how to implement CDISC standards in automated research data pipelines that are fast, scalable, and reliable.

  4. 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.

  5. 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.

  6. FDA's Elsa May Prompt Pharma To Rethink Regulatory Filings 8/13/2025

    AI expert Pradeepta Mishra of Beghou Consulting explains why pharmaceutical companies need to quickly evolve their regulatory strategies, authoring procedures, and governance frameworks in light of the FDA's new Elsa generative AI pilot.

  7. 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. 

  8. How Is RIM Software Transforming Regulatory Compliance? 6/20/2025

    Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.

  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.