GUEST COLUMNISTS

• Synaptic Regeneration And The Future Of Alzheimer's R&D

  For too long, treating Alzheimer’s disease has been a case of “managed decline.” We need to move beyond slowing disease progression toward achieving tangible functional recovery.

• FDA Form 483 Responses: The Difference Between Explaining An Observation And Demonstrating Control

  ADRES Bio's Rivka Zaibel walks sponsors through the proper response to an FDA Form 483, emphasizing the need to show understanding and control of the situation.

• Judgement-Based Project Management Builds Partners' Trust

  Project managers often operate under rules that govern how and when they execute tasks. But that doesn't always include room for individual judgment. But judgement, argues Jason Bork, is the differentiator in successful partnerships.

• How Did You End Up In Clinical Research?

  To commemorate Clinical Trials Day, we asked clinical researchers to share their story, answering, "How did you get into clinical research?"

• From CRO Management To Networked Governance: The New Quality Imperative

  The clinical research industry once emphasized transactional vendor management, but now it requires broader governance to enable the level of quality that enables scalability and success.

• Will FDA's One-Day Inspection Pilot Stand The Test Of Time?

  FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

• QA Transitions Don't Create Inspection Risk — They Reveal It

  Consultant Wijdan Suliman, MD, MHA, explains how QA leadership changes can reveal risks, including differences in the interpretation, lost historical context, and more.

• Contracting For AI In Clinical Trials: Cybersecurity, Monitoring, And Risk Allocation (Part 3)

  Leibowitz Law shares the third installment of its three-part series on contracting for AI in clinical trial operations. Part 3 picks up with cybersecurity, monitoring and validation, and risk allocation.