Newsletter | May 1, 2026

05.01.26 -- Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation

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FOCUS ON CLINICAL TRIALS

Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation

By E.H.P. Tan and J.W.Y. Leong, National University of Singapore

Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence. Review the highlights of the workshop here.

Real-World Evidence Revisited: The FDA's Device Guidance Changes

Article | Univo IRB

Explore how the latest regulatory updates transform real-world data into a credible evidentiary pathway. Understand the new standards for data reliability and hybrid study design.

Challenges That Derail Bladder Cancer Trials And How To Anticipate Them Earlier

Article | By Louise Scott, Ph.D., Worldwide Clinical Trials Oncology

From the rapid evolution of standard-of-care benchmarks to the logistical strain of procedure-heavy urology workflows, the path to a successful endpoint is filled with operational friction.

The Phase 2 Endpoint Dilemma: Subjective Scales And Objective Measures

Webinar | Avance Clinical

Phase 2 neuro endpoints can miss subtle change. Learn when composites help or hinder, how to align cognition, function, and biomarkers with real-world data for go/no-go decisions.

CLINICAL TRIALS SOLUTIONS

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Why Central IRBs Matter For Efficient Clinical Trials - BRANY

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