Newsletter | September 10, 2026

09.10.26 -- The Vanishing Middle: How Consultants And CROs Are Reshaping Clinical Trials

SPONSOR

Turning R&D pressure into strategic opportunity

Insights from the 2026 Pulse Survey of global drug development leaders. 
Sponsors that approach today’s common biopharmaceutical industry hurdles as opportunities to strengthen clinical development strategy, execution and patient focus may be better positioned for long-term success. Explore this article for deeper insights into the challenges and opportunities shaping modern R&D.

OUTSOURCING MODELS

Everyone Is A Consultant Now

Jon Newton argues clinical research’s “vanishing middle” is giving rise to a more flexible workforce of consultants, specialists, and boutique firms.

FSP Resource Efficiencies: Resolving Challenges, Optimizing Outcomes

Once used primarily by large sponsors and concentrated in specific areas, functional service providers (FSPs) have evolved alongside the growing complexity and costs of clinical research.

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.

Mitigating Risk And Complexity In Cell & Gene Therapy Trials With IRT

CGT pioneers require supply chain partnerships that mitigate trial risk and complexity. Explore how to optimize pre-trial and pre-screening activities and reduce trial cost and risk with an IRT solution.

Made-To-Order Gene Replacement Therapy Study Solution

Adopt a demand-led clinical supply strategy to reduce waste, optimize limited product supply, and accelerate patient access across global clinical trials.

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.

Migraine Research Expertise: A Full-Service Neuroscience CRO

Running a migraine trial? Learn how specialized neuroscience support, from PRO selection to real-time data review, can resolve common study delays and endpoint gaps.

Creating Powerful Partnerships

Deepen your impact in global healthcare through thought leadership, education, conferences, and partnerships that elevate visibility, strengthen expertise, and connect you with key HEOR stakeholders.

Ensure The Safe, Efficient Development Of High Potent Drug Products

As your product transitions from clinical phases to commercial launch, flexible, globally compliant facilities stand ready to adapt to your evolving needs.

Proven Expertise With Global Solutions For U.S. Biotechs

With over three decades of expertise, particularly in oncology, CNS disorders, and rare diseases, this company fosters relationship-focused partnerships with biotech firms.

REGULATORY COMPLIANCE

The Reality Of Clinical Research Federal Funding Cuts

Although the most catastrophic federal funding cuts didn't come to fruition, Pamela Garzone discusses where some impacts are being felt now and will be felt for years to come.

Build Systems That Scale With Every Stage Of Growth

Learn how to synchronize finance and R&D with a scalable operational framework. Automate manual steps and strengthen compliance to ensure your infrastructure evolves as fast as your science.

How Regulators Are Setting Standards For Digital Health Technologies

Digital health tools are changing clinical trials fast. See how regulators and researchers are keeping evidence rigorous and trial-ready.

Under Half Of CTIS Trials Met Results Reporting Requirements

A first assessment of compliance on EU Clinical Trial Information System (CTIS) found fewer than half of European Phase II–IV drug trials legally required to post results fully complied on time.

7 Practical Implications Of ICH E6(R3) For Early-Phase Trial Design

A risk-based quality approach can enhance participant protection, data integrity, and development success through focused oversight, strong governance, and clear documentation.

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