GUEST COLUMNISTS

• 5 Informed Consent Fixes For Sponsors And Investigators

  Informed consent has never been solely about documentation, but some sponsors has treated it as a checkbox exercise. Here, consultant Tasha Mohseni shares tips and fixs for how best to approach informed consent.

• Navigating The New EU Pharmaceutical Legislation: Key Implications For Pediatric Drug Development

  UCB’s Senior Development Strategy Lead Pediatrics Martine Dehlinger-Kremer, Ph.D., discusses updates to the new EU Pharma legislation and how they impact pediatric drug development, including earlier pediatric investigational plans .

• Why Life Science Tech Pilots Fail After The Demo — And How To Avoid It

  A working demo might look promising, but it doesn't tell you whether the tech can be shipped, integrated, validated, and accepted by regulator. Tech consultant Lukasz Lazewski explains how to look past the allure and evaluate its true functionality.

• The Profit Margin Double Standard That Needs To Change

  We expect pharmaceutical companies to have sizable profit margins, but we collectively scoff at research sites for achieving the same. Maria P. Ladd explores this difference in expectations and why it needs to change for the sake of the industry.

• Why The Governed Hybrid Site Model Is Strategically Superior — Part 3

  In the third and final part of this series, Paradigm Clinical Research CEO Kurt Mussina, who's become an advocate for the governed hybrid platform, explains why he believes it's the best fit for sponsors.

• Beyond The IND Clock: What Operation TrialBlazer Gets Right — And Where It Stalls (Part 1)

  The FDA's Operation TrailBlazer includes a proposal to speed up IND review and approval. But will it work? Kimberly Chew and Odette Hauke identify where the initiative succeeds and where the structural gaps begin.

• Beyond The IND Clock: The Legal Architecture Of QRIs And What Industry Must Say Before July 22 (Part 2)

  The FDA's Operation TrailBlazer includes a proposal to speed up IND review and approval. But Kimberly Chew and Odette Hauke say its legal architecture is unresolved and reveals compliance issues that are hard to ignore.

• Project Management And AI: What Should Be Automated And What Should Not

  How can clinical research project management be optimize by AI? To determine its best fit, consultant Jason C. Bork assess AI's utility in project management through the lens of Plan, Do, Check, Act (PDCA).