Newsletter | December 4, 2025

12.04.25 -- Identify Patient-Centric Risks In The TMF With AI And Automation

FEATURED EDITORIAL

How To Identify Patient-Centric Risks In The TMF With AI And Automation

Discover how AI and automation tools transform how we manage TMF content when it comes to identifying patient-centric risks.

INDUSTRY INSIGHTS

'Real' Evidence Generating Real Pre- And Post-Market Benefits

Review the current and future applications of RWD/E in drug discovery, clinical research, regulatory review and approval, and its role in promoting health equity and patient and provider access.

How eConsent Improves The Trial Experience For Patients And Sites

In part one of this series, the author dives into how electronic consent platforms are simplifying and improving the trial experience for patients and sites.

Precision Recruitment: Fixing The Future Of Clinical Trials

Explore how to design ethical, effective, and patient-centric AI-powered recruitment pipelines that truly connect the right patients to the right trials.

Health Economics And Outcomes Research (HEOR) Explained

Learn about this accessible way to understand what Health Economics and Outcomes Research (HEOR) is, how it’s used, and its impact on people and healthcare systems.

Accelerating Clinical Data Review With Traceable Workflows

Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.

Leading eSource Software Company Receives Part 11/Annex 11 Verification

Uncover how an independent confirmation of compliance opened up new opportunities and is instilling confidence in customers who are integrating the eSource system into their software validation strategy.

How Sponsors Can Drive Success With Central eSource At Investigator Sites

Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.

How Digitized Protocols Are Accelerating Clinical Research

Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.

Navigating Biases In Clinical Trial Vendor Selection

Biases, often hidden, can distort vendor selection decisions. Recognizing and addressing them across individuals and teams leads to more objective, aligned, and successful clinical trial outcomes.

Helping To Power The WHO Solidarity Trial Against COVID-19

To overcome the unprecedented challenges of large-scale global clinical trials, adopting data capture solutions is essential for ensuring the success of critical research initiatives.

SOLUTIONS

One Home for Sites Partnership Program Guide

Advanced EDC Functionality, Seamless Data Collection, Study Management

LEAP: A Multisensor Wearable For Patient-Centered Clinical Research

Not Just Any IRT: Trust For Complex Clinical Trials

Connecting Highly Qualified Patients To Clinical Trials