Clinical Guest Contributors

  1. 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.

  2. 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.

  3. AI-Enhanced Clinical Project Management For Cell And Gene Therapy Clinical Trials 8/12/2025

    Consultant Jessica Cordes explores two of the most critical uses of AI for cell and gene therapy clinical trials: real-time patient journey coordination and predictive enrollment. 

  4. You Just Secured $50 Million. Now On To The Hard Part: Clinical Trials 8/12/2025

    4C Associates' life sciences director Tom Wells explores common pitfalls of early-stage biotechs' transition into clinical trials and shows how early involvement of sourcing professionals can improve delivery, control spend, and help retain oversight.

  5. Running Global Clinical Trials? PolyPid Shares Operational And Regulatory Insights 8/11/2025

    PolyPid shares its clinical trial journey across the U.S., Europe, and Israel, highlighting operational complexities, regulatory navigation, and the adaptability required to execute large-scale, global studies. 

  6. 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.

  7. Heart-In-A-Jar Organ Model Earns Regulatory Respect After 25 Years In The Making 8/7/2025

    Aligned with new FDA support for new approach methodologies (NAMs), Ronald Li, Ph.D, and Kevin Costa, Ph.D., share their story of creating Novoheart's mini heart organ model and discuss its current use in clinical trials.

  8. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  9. What's Clinical Liability Insurance, And How Does It Work? 8/5/2025

    Life science insurance specialist Kristin Beaulieu explains why sponsors must develop a strategy for scaling their product liability insurance program, detailing two main product liability types to consider.

  10. 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.