Newsletter | February 12, 2026

02.12.26 -- What CROs Do Right Isn't Always Obvious To Research Sites

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REGULATORY & COMPLIANCE

The 'One-Trial' Trap: Why 2026's FDA Efficiency Push Actually Doubles Your Operational Risk

When it comes to the FDA's new "one-trial" shift, researcher Johnathon Anderson, Ph.D., warns: Do not confuse efficiency with leniency. Here, Anderson offers three factors to consider when adapting to new FDA trial expectations.

FDA Talent Loss Is Real — And It's Not Evenly Distributed

Hilary Marston discusses how staffing losses at FDA are uneven across divisions, with particularly heavy impact in innovative areas like AI and real-world evidence.

Why Early Medical Assessment Matters In Clinical Trials

Early medical assessment reduces risk, improves patient selection, and avoids trial delays. Learn how starting early boosts compliance, speeds timelines, and protects participants and results.

The Strategic Advantage Of Australia And Asia For U.S. Biotechs

Watch as this expert panel explores how Australia, Taiwan, and South Korea provide a strategic advantage in conducting early, mid, and late-phase oncology trials.

The Central And Eastern Europe (CEE) Clinical Trials Report

This 2024 Industry Pages report provides an in-depth examination of the Central and Eastern European (CEE) clinical trial strategy, highlighting its pivotal role in global drug development.

5 Clinical Research Predictions And What Actually Happened

Review 2025’s gap between artificial intelligence discovery and trial execution, highlighting legislative and FDA shifts to help sponsors operationalize participant experience for 2026.

3 FDA Approvals In 2025 That Shift The Landscape For 2026

In this presentation, Precision’s Chief Medical Officer and former FDA Director, Division of Oncology 2, Harpreet Singh, MD, breaks down three FDA approvals from last year that are impacting 2026.

OUTSOURCING MODELS

What CROs Do Right Isn't Always Obvious To Research Sites

CROs are doing many things right. But it's when that right thing is understood — not just executed — that the impact becomes far greater than compliance alone.

How A Strategic Bioanalysis CRO Partnership Empowers Sponsors

Choosing the right bioanalysis CRO is vital to avoid costly delays. Sponsors need evaluation strategies that prioritize proven quality, predictable timelines, and submission-ready data.

Optimizing Resupply To Reduce Risk Of Late Phase Delays

Philip Johnston, Clinical Supply Lead at Catalent Pharma Solutions, talks about best practices for efficient and timely clinical resupply and helping sponsors execute supply chain strategies.

Solving Problems, Building Partnerships: Insights From Steve Geffon

Explore how collaborative problem-solving and trust-based partnerships help study teams manage complexity, adapt to change, and align priorities for better outcomes across sponsors, CROs, and sites.

When Clinical Trials Drift Off Course

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

An Easy-to-Use Analytics Platform For Vendor Selection, Management

Automate RFPs, select the right vendors, and manage them financially — track change orders, monitor projections vs. actuals, and drive smarter decisions with advanced analytics.

Biorepository And Lab Services

Beyond basic storage, our comprehensive services deliver fully compliant, state-of-the-art environments where samples are meticulously cataloged, tracked, and maintained with precision.

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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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