Newsletter | January 9, 2026

01.09.26 -- Meet FDA Expectations For Hybrid And Decentralized Trial Oversight

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Live Event: The FDA Year in Review — And What Comes Next

The FDA didn’t sit still in 2025, and neither can you. Our industry insider panelists will cut through the noise to explain which regulatory shifts, guidance updates, and inspection trends really matter for clinical trials in 2026 — and what you should do about them. Click here to learn more.

CLINICAL DATA MANAGEMENT & ANALYTICS

Adaptive Trial Design Is Changing Oncology And Hematology Clinical Trials

Shreya Badhrinarayanan, MD, explains how adaptive trials, enriched by AI and better data integration, are transforming oncology and hematology clinical research.

Sanofi's Take On The Evolving Role Of AI In Clinical Trials

Matthew Peruhakal, Global Head of Data Architecture, Utilization, and AI Engineering at Sanofi, offers a deep look at how the pharmaceutical giant is integrating AI to transform clinical trials.

Biopharma Giant Streamlines Infrastructure With Proprietary Software

Archiving legacy QMS systems into a centralized platform reduced costs, simplified access, and improved efficiency for a global diagnostics company undergoing quality process harmonization.

Hidden Costs Of Data Cleaning: Build Quality At The Source

Hidden costs from downstream data cleaning slow trials and raise risk. Explore why building quality at the source accelerates timelines, reduces errors, and gives sponsors a competitive edge.

5 Ways Lab Data Can Help Commercialize Your Therapy

Delve into five pivotal insights for leveraging lab data effectively and the collaboration that accelerated market entry for new therapies while ensuring the needs of targeted populations were met.

Distribute, Monitor, And Exchange Study Documents With Every Site

Bridge the digital divide in clinical trials. Streamline workflows between sponsors and research sites to accelerate study timelines, improve data quality, and ensure constant inspection readiness.

Clinical Trial Forecasting Suite

An AI-powered platform designed to revolutionize clinical trial planning and execution leverages deep learning and proprietary performance data to deliver highly accurate, real-time forecasts.

Modernize Clinical Research With Continuous Digital Data

Utilize high-precision sensors and advanced algorithms to capture real-world evidence, improve decision-making, and streamline operations across every phase of clinical development.

TRIAL MONITORING

How To Meet FDA Expectations For Hybrid And Decentralized Trial Oversight

Former FDA attorney Claire Davies shares strategies for meeting regulators' expectations for hybrid and decentralized clinical trial oversight.

New ICH GCP Changes Center The Patient

Explore key changes to the guidelines and how they're transforming clinical trials with a focus on patient centricity, digital innovation, and risk-based quality management.

CHOOSE YOUR OWN ADVENTURE

You're receiving the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial Monitoring. 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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