GUEST COLUMNISTS

• What Sponsors Don't See: The Systems Behind Clinical Trial Delivery

  What do sponsors need from sites? Easy. How do they evaluate them? Not so easy (or accurate). In this column, Association Multisite Research Corporations (AMRC) Executive Director Jim Kremidas explains how sites and sponsors can make site evaluations better.

• What Really Happens At The Site When Sponsors Pull Back Mid-Trial

  When sponsors slow or reduce operational spending due to financial pressure, strategic pivots, or internal restructuring, sites — and patients — suffer. Curo Research CCO Amy Bland explains how sponsors can better manage operational changes.

• A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROI

  Clinical technology consultant Karen Maduschke explains why your next AI investment should solve a problem you can articulate, with data you can access, in a process you can change.

• One Drug, Three Indications: How Small ClinOps Teams Manage Multi-Trial Execution

  Having the same number of clinical programs as team members might sound crazy, but for Step Pharma, it has become one of their biggest strengths.

• Rare Disease Nonprofits: De-Risk Development With Orphan Drug Designation And Early Talks With The FDA

  For nonprofit organizations, Orphan Drug Designation is the start of a disciplined, forward-looking regulatory strategy, but it's not the only factor in success. H. Greg Thomas, Ph.D., shares his advice for de-risking orphan drug development.

• The Compliance Problem With Excel Trackers And Other Computational Tools — And How AI Can Help

  Everyday computational tools such as Excel are simple and easy to use, but they carry risk. Learn how these tools might not adhere to 21 CFR Part 11, and discover how AI can help keep them compliant.

• To Prevent Parkinson's Disease, We Need New Biomarkers

  Parkinson's disease research has shifted toward prevention and prodromal intervention but success with disease-modifying and preventive therapies depends on validated PD-specific biomarkers. AC Immune Cofounder and CEO Andrea Pfeifer explains.

• What It's Like To Advance A Cell Therapy Through The Japan Entry Acceleration Program

  Ernexa Therapeutics President & CEO Sanjeev Luther details having one the of 10 coveted spots in the Japan Entry Acceleration Program (JEAP) that supports cell therapy development and market entry in Japan.