Newsletter | February 5, 2026

02.05.26 -- What To Watch For In The 2026 Clinical Trial Landscape

OUTSOURCING MODELS

Working (Successfully) With Pharma: A PAG's Perspective

TSC Alliance President and CEO Kari Rosbeck details the patient advocacy group's unique relationship with Aeovian Pharmaceuticals in developing the company's first-in-class selective mTORC1 inhibitor for TSC-related refractory epilepsy.

Leverage Modeling And Simulation In The Candidate Development Stage

Modeling and simulation provides another way to predict the clinical performance of a molecule, based on a robust and holistic approach, before investing the required time and money.

Tech Transfer Strategies For mAb Drug Products In Late-Phase Launch

Tech transfer is not just a process of replicating manufacturing steps; it is a complex, multidisciplinary effort that ensures process robustness, scalability, regulatory compliance, and supply chain readiness.

A CRO Accelerating Bioanalysis

Move drug development into the modern era with a CRO that offers assay development and validation, bioanalytical testing, sample prep, and more.

APAC's Advantage In Oncology Trials

Partnering with Southern Star Research provides access to deep regional expertise, operational excellence, and a proven track record of delivering high-quality clinical trials.

REGULATORY & COMPLIANCE

FDA Year In Review — And What Comes Next

The FDA didn’t sit still in 2025, and neither can you. Our industry insider panelists, Sophia McLeod, Elizabeth Jungman, and Hilary Marston, M.D., M.P.H. cut through the noise to explain which regulatory shifts, guidance updates, and inspection trends really matter for clinical trials in 2026 — and what you should do about them.

Most Ex-U.S. Countries Can't Access The Medicines They Help Study

When a country hosts a clinical trial, we assume patients there will benefit from the therapy they helped test. Research Jennifer E. Miller, Ph.D., says that's not often the case.

Clinical Development Crystal Ball: What To Watch In 2026

Explore how AI integration, remote assessment, and precision measurement are reshaping clinical trials in 2026 to improve data quality and patient outcomes.

Challenges With Hallucinogens, Psychedelics, And Entactogens

Examine the complex regulatory landscape and the preclinical, clinical, and manufacturing challenges involved in developing Schedule 1 therapeutics.

A Map For The Clinical Trial Registry Maze

Navigating the Clinical Trial Registry Ecosystem — Regional and Global Registry Selection provides harmonization initiatives to improve transparency and data consistency across registries.

Psychiatric Drug Development Renaissance: With Familiar Risks

Emerging psychiatric therapies bring hope, but progress is fragile. Biomarker-driven, mechanism-first approaches help overcome biological, regulatory, and commercial barriers.

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.

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)

Learn more about our personalized newsletters here.

Connect With Clinical Leader: