Newsletter | June 25, 2026

06.25.26 -- An Inside View Of The Clinical Trials Technology Congress

OUTSOURCING

A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROI

Clinical tech consultant Karen Maduschke explains why your next AI investment should solve a problem you can articulate, with data you can access, in a process you can change.

Vendor Selection Bias: Why Structured Decisions Often Fail

Learn how subtle influences derail decisions and discover proven safeguards that promote transparency, accountability, and shared ownership for better trial outcomes.

Why Asia Should Be Your Next Trial Destination

Escape US site bottlenecks by moving oncology research to Asia. Discover how you can connect with diverse patient pools at premier research centers with lower overhead.

Speed, Precision, Impact: The CRO Revolutionizing Bioanalysis

Move drug development into the modern era with a CRO that offers assay development and validation, bioanalytical testing, sample prep, and more.

Advanced Drug Delivery And Device Combination Product Solutions

Explore how you can obtain end-to-end injectable services with a company offering a comprehensive approach to providing easy-to-use, patient-centric therapies.

REGULATORY COMPLIANCE

My View: The Clinical Trials Technology Congress

I attended the inaugural Clinical Trials Technology Congress in London expecting to hear plenty about AI, digital tools, and the future of clinical trials. What stood out instead was how many speakers focused on a much more immediate issue: reducing complexity for sites, patients, and study teams.

A New Biomarker Risk Score May Improve Prognosis And Trials In Idiopathic Pulmonary Fibrosis

A new biomarker risk score developed by the Pulmonary Fibrosis Foundation's PROLIFIC consortium could serve as the latest prognostic or predictive tool in clinical trials and care. for those diagnosed with idiopathic pulmonary fibrosis (IPF).

FDA Nudges Sponsors To Disclose Clinical Trial Results

In March, the US FDA sent thousands of reminders to submit clinical trial results to ClinicalTrials.gov or complete the federal-mandated National Library of Medicine quality control review process.

Rethinking How We Forecast Clinical Trial Timelines

Machine learning is transforming clinical trial reporting by replacing static enrollment forecasts with dynamic, real-time milestone projections that improve predictability and oversight.

5 Questions To Ask Before Selecting A Randomization Partner

Choose the right IRT partner for complex master protocols. Learn how adaptive randomization expertise and flexible technology reduce disruption and keep trials execution-ready.

What The FDA/EMA's AI Principles Mean For Clinical Trial Technology

New FDA/EMA principles align global expectations for AI in drug trials, emphasizing transparency, human-centric design, and risk-based governance to ensure data integrity and patient safety.

Real-World Evidence Revisited

Explore how the latest regulatory updates transform real-world data into a credible evidentiary pathway. Learn the new standards for data reliability and hybrid study design.

US Healthcare System Overview

A clear guide to U.S. coverage, regulation, and reimbursement: who decides care, how products gain access, and how policy and financing shape cost, value, and patient access.

Clinical Research Trends And IRB Expectations For 2026

Oversight in 2026 requires adaptability as AI, consent standards, and regulatory uncertainty challenge sponsors and IRBs to balance ethics with innovation through proactive planning and collaboration.

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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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