GUEST COLUMNISTS

• Accountability Gaps Can Break Clinical Supply Contracts

  Contract gaps can create clinical supply failures when responsibilities differ across agreements. See how aligning obligations can prevent costly disputes, delays, and risks.

• 'How Do You Feel?': Designing A Cardiac Trial With A Patient-Reported Primary Endpoint

  Imbria Pharmaceuticals' Albert Kim, MD, Ph.D., shares why PROs are the point of the company's FORTITUDE-HCM trial for patients with non-obstructive hypertrophic cardiomyopathy.

• Sustainable Patient Engagement: Your Enrollment And Representation Depend On It

  Early and ongoing patient engagement is a crucial component to staving off recruitment trouble and securing proper patient representation. Boehringer Ingelheim's Karen Correa, Ph.D., explains how.

• Building The Execution Architecture For Real-World Data To Have Real-World Impact

  RWE's next challenge is execution. Learn how life sciences orgns can turn evidence into sustained business and clinical impact.

• Stock Options: Choosing The Right Viral Inoculum For An Early-Phase Norovirus Trial

  Viral stock can make or break a norovirus challenge study. Cocrystal Pharma's Sam Lee explains why inoculum quality, infectivity, and availability matter.

• The Reality Of Clinical Research Federal Funding Cuts

  Although the most catastrophic federal funding cuts didn't come to fruition, Pamela Garzone discusses where some impacts are being felt now and will be felt for years to come.

• Everyone Is A Consultant Now

  Jon Newton argues clinical research’s “vanishing middle” is giving rise to a more flexible workforce of consultants, specialists, and boutique firms.

• Rare Disease Study Gets A Boost From Crowdsourced Patient Reported Data

  Jen A. Levitt, MD, explains how crowdsourced patient-reported data and AI tools can compress rare disease research timelines and surface new signals.