Newsletter | December 18, 2025

12.18.25 -- Choosing The Right Outsourcing Model Starts With Strategy

SPONSOR

Clinical trials drive medical progress, and SCOPE brings the community together to advance them. Returning February 2–5, 2026, in Orlando, SCOPE builds on 2025’s record 4,500+ attendees, 630 speakers, and 300 exhibitors. The 2026 program features 30 tracks, new additions in Market Access, Safety, and Therapeutic Areas, major awards, and expanded coverage of AI, patient-centric design, site engagement, and trial operations. SCOPE unites global leaders shaping the future of clinical research. www.SCOPEsummit.com

REGULATORY & COMPLIANCE

How EDC Drives End-To-End Data Management In Pharma Clinical Trials

The EMA has issued draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

Why Compassionate Use Should Not Replace Rigorous Clinical Trials

While compassionate use and expanded access programs provide lifesaving treatments outside clinical trials, the lack of structured protocols can lead to inconsistent data, compromising crucial evaluations.

Ensure IRB And IBC Success For Gene Therapy With Strategic Planning

To successfully bring innovative gene therapies to patients with neurological disorders, drug sponsors must design safe and compliant clinical trials with rigorous approaches to ethics and consent.

How ICH Oversight And AI Are Shaping The Future Of Clinical Trials

Explore how the new ICH E6 (R3) revisions are reshaping clinical trial oversight and examine how AI-driven tools like the Clinical Decision Suite can help sponsors enhance trial efficiency.

Navigating AI And Regulatory Shifts In Clinical Operations And Supply

AI is transforming clinical trials. Learn how strategic adoption and cultural readiness can unlock efficiency, resilience, and compliance in an evolving global landscape.

Driving Mid-Size Pharma With Integrated Development And AI

A consultative, tech-enabled CRO can help mid-size pharma achieve targets by supplementing skillsets, expanding global reach, and designing an effective clinical, regulatory, and operational strategy.

Building A High-Quality IND From Scratch With Strategic Gap Analysis

A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

OUTSOURCING MODELS

Choosing The Right Outsourcing Model Starts With Strategy

Before picking an outsourcing model, companies must know what they’re trying to achieve. Jeremy Weitz, Director of Procurement for Global Clinical Services at Biogen, explains how aligning operating models with business strategy leads to better scalability, flexibility, and quality outcomes.

The Shift Toward Flexible FSP Models

Flexible FSP models are reshaping clinical outsourcing by offering sponsors scalable, cost-predictable partnerships that preserve control, enhance quality, and support long-term strategic goals.

FSP Efficiencies: Overcoming Challenges And Optimizing Outcomes

Originally focused on large sponsors in areas like monitoring, biometrics, and safety, functional service providers (FSPs) have evolved to meet the rising complexity and cost of modern clinical research.

Mastering The Complexities Of Gene Therapy Document Writing

Gain the insight and strategic flexibility needed to confidently navigate unique scientific, regulatory, and documentation challenges of gene therapy development.

The Rescue Option: Course Correcting Struggling Clinical Trials

The willingness to seek expert support from Rescue CROs when clinical trials face critical challenges is not a sign of weakness but a demonstration of accountability and commitment to excellence.

A Biologic Drug's Analytical Journey

Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and more.

The Hidden Cost Of Preferred Vendors

Familiar vendors offer comfort — but at the cost of innovation, fit, and fresh thinking. Ease shouldn’t outweigh excellence when selecting partners for your clinical trial.

Flexible, Resilient, And Patient-Centric Clinical Supply Chain Design

Flexible solutions, like demand-led supply and direct-to-patient distribution, are helping sponsors address the growing list of challenges presented by today’s increasingly complex studies.

Autoinjectors For Autoimmune Diseases: Benefits And Considerations

By improving convenience, ensuring precise dosing, and reducing dependency on healthcare facilities, autoinjectors enhance patient outcomes and quality of life.

Accelerated Peptide Drug Development And Clinical Strategies

Review how an integrated platform approach and innovative filtration strategies helped bring a novel therapeutic to Phase 1 clinical trials with reduced time and costs.

Clinical Trial Services

Explore the latest trends in sustainable living and guarantee the proper handling of your clinical materials to cover everything from warehousing and distribution to returns, collection, and destruction.

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.

TFS's Expertise In Strategic Resourcing Solutions

Partnering with TFS offers flexible, scalable sourcing solutions for clinical development, supporting trials from early discovery through post-market, regardless of therapeutic area.

Early-Phase Oncology Research Expertise

Our priority is guiding promising therapies to proof-of-concept with precision and urgency, because every day saved in development matters profoundly to patients living with cancer.

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)

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