GUEST COLUMNISTS

• Your Company Needs Compliance Expertise — But When And From Whom?

  When should a biotech formalize compliance? Learn how risk, funding, clinical activity, and commercialization shape the right expertise and structure.

• 5 Sponsor Contracting Issues That Delay Clinical Trials — And How To Avoid Them

  CTA negotiations don’t have to stall study start-up. Learn five sponsor-side contracting issues that cause delays and practical ways to prevent them.

• Participant Payment — Make It Make Cents

  Participant payment practices and expectations vary wildly. With advocate T.J. Sharpe, explore why sponsors need to rethink how they appreciate participants' time, effort, and burden.

• What Ecological Momentary Assessment Taught Us About Real-World Hearing Outcomes

  Ecological momentary assessment (EMA) reveals how people experience hearing challenges beyond the clinic. Here, researchers highlight its relevance in designing real-world hearing studies.

• Calidi's Study Aims To Have An Oncolytic Virus Outsmart The Immune System

  Calidi’s Eric Poma, Ph.D., explains how CLD-401 could evade immune clearance — and how the biotech is designing Phase 1 to prove safety and efficacy fast.

• New Imaging Approach Could Improve IPF Trial Design

  AI-powered quantitative CT could help sponsors detect treatment effects earlier, strengthen IPF trial endpoints, and make better go/no-go decisions.

• Most Patients Learn About A Trial Online, But Is That What They Want?

  Patients want to hear about clinical trials from their doctors — but most learn out online. CISCRP explores how industry can change the referral pathway for better.

• How Plain Language Summaries Created Under EU CTR Can Help Shape NIH Policy

  As the NIH shapes its plain language summary policy, EU CTR experience offers practical lessons on clarity, privacy, consistency, and implementation.