Newsletter | January 29, 2026

01.29.26 -- Mock Inspection Advice From Former Regulatory Investigator

REGULATORY & COMPLIANCE

Mock Inspection Advice From Former Regulatory Investigator

Former FDA investigator Alia Legaux, D.H.Sc., runs through her top tips for running a mock investigation.

Proving The Return On Investment For eRegulatory

Explore a study of how leading research centers, CROs, and sponsors cover the cost of eRegulatory tools … and then some.

ICH GCP E6(R3) Implementation: Real-World Considerations

Access the full brief to learn how a phased, 12–18-month approach can help you meet ICH GCP E6(R3) requirements with confidence and avoid the costly pitfalls many organizations overlook.

Driving Safety And Compliance Seamlessly

Whether it’s accelerating market entry with the “FSP Country in a Box” solution or maintaining global compliance through expert oversight, IQVIA empowers organizations with scalable, localized support.

Navigate The Future: Your Essential Guide To ICH E6(R3) GCP Changes

The long-awaited ICH E6(R3) guideline is here and will reshape clinical trial standards. Get ahead of the transition with a detailed comparison and strategic insights designed for sponsors and CROs.

OUTSOURCING MODELS

Find The Right Operational Fit In Today's FSO–FSP Landscape

Clinical outsourcing is shifting from FSO vs. FSP debates to value-driven strategies. Success depends on alignment, governance, and oversight, with hybrid models rising among biotechs and structural FSP dominance in large pharma.

FSP Vs. FSO: It's No Longer Binary

Samir Shah, Principal at Shaw Pharma Consulting Services, outlines how today’s outsourcing exists on a continuum — where companies mix elements of both models based on their core and critical competencies rather than forcing a one-size-fits-all structure.

A Biologic Drug's Analytical Journey

Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and more.

Is Your Help Desk A Lifeline Or A Landline?

A help desk should accelerate trial success, not create delays. Discover how proactive support and modern tools turn help desks into strategic assets that improve efficiency and reduce risk.

Driving Precision, Agility, And Partnership In Drug Development

Anshul Gupte Ph.D., shares insight about phase-appropriate development, technical hurdles, building agile teams, and planning strategy for novel therapies.

Commercial Drug Sourcing For Clinical Trials

Learn how the right partner can leverage years of experience, market knowledge, industry relationships, and clinical packaging expertise to develop a sourcing strategy tailored to the needs of each study.

Accelerating FIH Trials To POC With Speed, Safety, And Certainty

Overcome clinical transition challenges with integrated services, including study design, expert regulatory support, robust recruitment, and flexible manufacturing.

Empower Your Research Sites With A Full-Service Marketing Solution

With the Research Study Rockstar platform, sites can finally run recruitment like a marketing agency—without needing one.

When Clinical Trials Drift Off Course

Recovering lost clinical trials is an art. Learn how we triage your study’s problem areas, build recovery strategies to address your drifting trial’s performance, and deliver results.

CHOOSE YOUR OWN ADVENTURE

You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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