Newsletter | June 11, 2026

06.11.26 -- Why Contracts Need To Catch Up To AI Appears In Clinical Trials

SPONSOR

The Pulse: Global R&D Insights in Pharmaceuticals

Uncertainty is shaping every major decision in drug development. Discover what 150 global biotech and pharma leaders say about navigating cost, complexity, regulation, artificial intelligence, and partnerships in 2026. Explore shifting research and development priorities in an uncertain market, the growing impact of artificial intelligence on development performance, the strategies gaining traction, and how organizations are managing the balance between speed, cost, and complexity.

OUTSOURCING

Where AI Appears In Clinical Trials — And Why Contracts Need To Catch Up (Part 1)

Leibowitz Law's three-part series examines how AI is being used in clinical trial operations and the contractual and operational risks that follow. Part 1 outlines where AI appears in ClinOps and supporting technologies, and the questions companies and organizations should ask when AI touches data.

How Smaller Biotechs Are Rethinking CRO Relationships Post-Pandemic

Smaller biotechs are rethinking CRO partnerships, valuing speed, scientific access, flexibility, and transparent pricing over scale — driven by pandemic lessons and a sharper focus on operational fit.

How Australia's Top CRO Speeds Biotech To Global Markets

The next era of clinical trials will be defined by global expansion across the Asia-Pacific region, rapid and cost-effective pathways to regulatory approval, and reliable, patient-centric leadership.

Packaging As Strategy: Enabling Clinical-To-Commercial Success

Explore how strategic, integrated packaging can accelerate clinical-to-commercial success while enabling patient-centric, scalable, and globally resilient drug delivery.

Delivering Oncology Clinical Trial Excellence Worldwide

Accelerate oncology programs with deep therapeutic expertise and global scale. Master the complexities of ADCs and cell therapies through agile execution and high-retention project teams.

Your Partner For Faster, More Advanced Phase 1 And 2 Trials

Early-phase clinical research experts, specialized in first-in-human trials, clinical pharmacology/NDA-enabling studies, and proof-of-concept studies. 

Why Functional Outsourcing Is Important To Clinical Development

Why is functional outsourcing important in today's clinical development environment, and where can you find scalable support that will flex with your changing needs?

SPONSOR

SCOPE Europe

Step into the future of clinical operations excellence at CHI’s 9th Annual SCOPE Europe: Powering Clinical Research event. Held at InterContinental Barcelona, 13–14 October 2026, this three-day program features case studies, strategic insights, networking, workshops, seven conferences, and Capital & Innovation programming for senior clinical professionals globally attended. Join 800+ senior executives from 300 organizations across 30 countries to explore clinical trial innovation, planning, and operations excellence leaders worldwide community. SCOPE Europe

REGULATORY COMPLIANCE

The FDA Is Rudderless And Clinical Trials Are Left Adrift

Former commissioner Marty Makary, MD, left the FDA in May 2026. In his wake, he left an agency facing yet another wave of uncertainty. Denise N. Bronner attempts to navigate the latest change and offers advice for those seeking stability.

What Does The FDA's 2025 Safety Reporting Guidance Mean For You?

New FDA guidance aligns IND safety reports with unanticipated problems, shifting the focus from administrative definitions to proactive participant protection and trial integrity.

State Of Materiovigilance: Gaps, Technology & Outsourcing

Explore how pharma and biotech companies are using AI, outsourcing, and new technologies to strengthen materiovigilance for complex drug-device products.

Definitive QT Evaluation - Clinical And Operational Considerations

QT strategy decisions affect timelines, cost, and regulatory outcomes. This presentation examines when early QT data can support a waiver, how guidance updates influence study design, and more.

Reviewing Protocols Across Therapeutic Areas

A successful clinical trial starts with an efficient protocol review. Get your clinical trial to the start line while ensuring participant health and safety.

The Most Adopted eISF For Faster Clinical Trials

Modernize your study binder processes with Florence eBinders™, offering remote access for sponsor interactions, monitoring, and source data review.

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