Newsletter | January 15, 2026

01.15.26 -- 2 Expectations And 2 Warnings For The Year Ahead

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REGULATORY & COMPLIANCE

Poland: An Underestimated Clinical Trials Powerhouse

Poland is not "one of the good options" or "an interesting emerging market," says Tomasz Szelag, head of clinical operations, Ryvu Therapeutics. Rather, it should be one of the first places sponsors look to run their clinical trials.

Trials Without Borders: Episode 5

We explore Canada's clinical trial ecosystem with expert panelists Erin Cherban (Chief Clinical Research Officer, Centre Advancing Health Outcomes/CIHR Pan-Canadian Network), Melissa Bomben (CEO, True North Innovation Agency and fractional COO of Biorasi), and Sergey Nikitin (Founder and President, Prime Site Research Solutions Inc.).

Accessing Unapproved Therapeutic Modalities In The U.S. And Australia

Learn about the regulatory frameworks developed by the United States and Australia to provide access to unapproved therapies for patients with serious or life-threatening conditions.

Regulatory Opportunities For Decentralized Clinical Trials

Project SHASTA, a pioneering effort to measure the benefits of decentralized trial elements, reveals significant regulatory opportunities that could shape the future of clinical research.

Is Your Clinical Trial Portfolio CTIS Compliant?

The Clinical Trials Regulation and its centralized digital platform, the Clinical Trials Information System (CTIS), are now mandatory. Are you prepared to navigate your next clinical trial in the EU?

Aligning Global Standards For ICH E6(R3) And Artificial Intelligence

Global standards and AI are transforming clinical research. Learn why mastering ICH E6(R3) and risk-based compliance is critical for data integrity and future success.

How Early-Stage Planning Strategies Are Optimizing Drug Development

Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

Beyond Traditional TRSM: Transforming Clinical Operations At Scale

Explore how organizations can transform from managing dozens of siloed, protocol-specific RTSM implementations to achieving unified, portfolio-level clinical operations.

OUTSOURCING MODELS

2 Expectations And 2 Warnings For The Year Ahead

Just when I thought I was done with 2026 predictions for the clinical trial industry, three members of my editorial board emailed me some great ones. What’s interesting is that two of these submissions, coincidentally, are focused on optimism for AI. In contrast, Denise Bronner’s forecast for the coming year is much more … well, dire.

Why Use Scorecards To Make Vendor Selection Decisions

Scorecards enable structured, unbiased vendor selection by transforming complex clinical trial decisions into transparent, data-driven evaluations — ensuring operational excellence and regulatory compliance.

Enhancing Preclinical Analytics to Drive Clinical Success

Bioanalysis is crucial for biopharma success. Here, Ander Tallett discusses selecting a bioanalysis CRO and collaborating effectively for assay results that accelerate drug development.

Improving ISR Success Rates In Bioanalysis Of Small Molecule Drugs

Leveraging incurred sample reanalysis (ISR) in your quality control helps your team mitigate risks, establish regulatory compliance, and instill confidence in your pharmacokinetic modeling.

Integrating Early Development With Clinical Supply

In the era of seamless development, reducing time to the clinic and getting rapid approval is key. An integrated approach can accelerate timelines, avoid communication pitfalls, and improve outcomes.

How To Capture Growth In The Expanding Metabolic Drug Market

Driven by GLP-1 success and rising obesity rates, R&D investment in metabolic disease therapies now rivals oncology, demanding rapid development to overcome market challenges.

Reimagining How You Bring Life-Changing Therapies To Patients

Leverage advanced automation and data-driven insights to accelerate clinical timelines, improve site engagement, and ensure life-changing therapies reach the patients who need them most.

Your Global CRO Partner In Oncology And Hematology

Learn about an organization dedicated to providing personalized and adaptive trial solutions and managing complex oncology and hematology clinical trials.

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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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