Newsletter | January 22, 2026

01.22.26 -- The Next Stage Of Clinical Trial Transformation

SPONSOR

Charting the Path to First-In-Human: Strategic Readiness for Early Clinical Success

The road to first-in-human is one of the most pivotal—and complex—stages in drug development. Join experts as they outline proven strategies for navigating each phase of early clinical readiness and IND preparation. Learn how to anticipate challenges, align cross-functional teams, and build the operational “trail map” that ensures your program reaches its first patient efficiently and compliantly. Click here to learn more.

OUTSOURCING MODELS

CRO Industry Outlook 2026: The Next Stage Of Clinical Trial Transformation

Beroe research manager Mathini Ilancheran reflects on the advances in AI, the rise of APAC as a global trial hub, new regulatory expectations, and increasing scientific complexity and forecasts how they will impact CROs in the coming year.

Embedding FSP Teams Into The Company Culture

In this segment, Lois Kelly, VP of Research and Clinical Operations at the National Down Syndrome Society, describes how shared holidays, team events, and open communication helped FSP staff feel valued.

TPDs: Developing The Next Generation Of Oral Therapeutics

Targeted Protein Degraders are a revolutionary drug class with challenges in bioavailability and formulation complexity. Strategic CDMO partnerships are key to successful, scalable development.

Bioanalytical Solutions: Discovery PK To Post-Marketing Surveillance

Explore how SGS's Hudson facility can enhance your drug development process by providing cutting-edge bioanalytical testing solutions and seamless global support.

Making The Case For Case Management For Cell And Gene Therapies

It is crucial to ensure that CGT supply chain risks are mitigated and that proactive strategies are implemented to address unforeseen challenges before they become an issue.

Accelerate Development And Address Complex Solubility Challenges

Explore how a platform integrating drug substance, drug product, and clinical testing within a single organization accelerates development and reduces costs, helping deliver positive outcomes earlier.

Finding The Right CRO Partner For Early-Stage Oncology Trials

Discover how a data-driven CRO selection framework can replace manual processes, minimize bias, and build stronger, more collaborative sponsor–vendor relationships.

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.

Accelerating Biologics Through Development Milestones

Whether you're aiming to run a pivotal trial or multiple studies, discover how Veristat's full-service support can drive your biologic therapies from inception to market success.

Partner Clinical Specialist Across Therapeutic Areas

Achieving global regulatory approvals through deep scientific expertise and extensive knowledge across a range of specialized therapeutic indications.

SPONSOR

ISPOR 2026

The healthcare landscape is evolving at unprecedented speed, and policy makers and payers are facing mounting pressure to make evidence-based decisions that balance innovation with sustainable access. Join global healthcare leaders, researchers, and decision makers at ISPOR 2026 where HEOR will be put at the forefront of policy, access, and value, highlighting its transformative role in advancing patient-centered care, strengthening global health systems, and addressing pressing challenges.

REGULATORY & COMPLIANCE

AI At The FDA: Legal Implications And Strategic Considerations For Drug Developers

AI-assisted reviews are changing FDA submissions. In part one of this two-part series, familiarize yourself with the FDA's use of AI and key legal concerns it raises.

Regulatory Comparisons For Starting First-In-Human Clinical Trials

Engage early with regulatory and clinical experts to navigate evolving global requirements and ensure your first-in-human strategy supports downstream development and multinational approvals.

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.

Harness AI Beyond Chatbots To Innovate Medical Information Offerings

Take an in-depth look and the challenges and benefits of incorporating AI solutions to enhance Medical Information (MI) services and the necessity of regulatory compliance.

Reviewing Protocols Across Therapeutic Areas

Get your clinical trial to the start line while ensuring participant health and safety. Learn how we are uniquely positioned to meet your cost and speed requirements.

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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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