Featured Editorial

  1. 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.

  2. 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.

  3. How To Pick The Perfect ePRO/eCOA For Your Trial (And Everyone In It) 9/8/2025

    Choosing the right ePRO/eCOA platform isn’t about comparing feature lists. It’s about asking: Will this work for patients, for sites, and for the trial as a whole?

  4. How AI Can Accelerate Clinical Trials' Probabilities Of Technical And Regulatory Success (PTRS) 8/21/2025

    AI expert Kelly H. Zou, Ph.D., explores how the technology can drive R&D successes, including clinical trials.

  5. 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.

  6. Synthetic Control Arms: When Data Stands In For Patients 8/14/2025

    Synthetic control arms replace traditional control groups with carefully matched historical or real-world data, offering an option for rare diseases, ethical constraints, or when high-quality datasets exist. They can speed access to treatments, but success depends on rigorous data matching, upfront planning, and early regulatory engagement.

  7. 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.

  8. Can Digital Endpoints Really Accelerate Clinical Trials? 8/8/2025

    Digital biomarkers are quickly and quietly becoming the digital revolution needed to make clinical trials quicker and more data rich. Discover how they are being used in clinical trials right now.

  9. 4 Clear Trends In Outsourced Clinical Services 8/4/2025

    Discover the four dominant trends in outsourced clinical and eClinical services for 2025, with insights derived from an annual survey by L.E.K. Consulting.

  10. Paving The Way For Sites To Use Their Own Tech 7/17/2025

    The DTRA has released a detailed playbook to help clinical research sites use their own validated technology in sponsor-led trials. The "Bring Your Own Technology" (BYOT) model aims to reduce tech overload at sites, improve efficiency, and preserve regulatory compliance — starting with eConsent as its first use case.