Learn how to comply with the EU AI Act when AI is used in GCP-critical eTMF contexts in part two of this series by Donatella Ballerini.
- How Can AI Change Computerized System Validation?
- Digital Tools Are Failing Patients: 3 Ways Clinical Supply Can Protect Data Integrity
- Virtual Reality Endpoints Improve Measurement Of Patients' Real-World Benefit
- Can't-Miss Advice On Selecting Your First AI-Enabled Vendor
- The Site Perspective: Why Ambient AI Is The Missing Link In Clinical Trial Data Integrity
- Why HEOR Keeps Arriving Too Late — And How ClinOps Can Fix It
- Accelerating Clinical Innovation With Open-Source Medical Platforms
- From Supercomputers To The Cloud: How Pharma's R&D Infrastructure Transformation Impacts Clinical Trials
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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The Stakeholder Benefits Of EHR eSource In Clinical Trials
Discover the transformative power of EHR eSource integration through the eyes of a clinical research coordinator and project director in an adaptive platform trial.
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Achieving Person-Centricity In Clinical Trial Recruitment
Clinical trial enrollment remains a major bottleneck in drug development, but consumer-centric innovations could present a solution to enhance every stage of clinical trial enrollment.
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To Counter Bias, Counterbalance
It’s easy to overlook the effects a survey’s format can have on responses, but those effects are potent sources of bias. Modern EDC allows you to systematically vary both question and response option order. This practice, called counterbalancing, guards against unwanted order effects.
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Lessons From China And The United States On The Use Of RWE In Regulatory Submissions
Read along as authors share their most significant lessons, offering guidance on how to harness the full potential of RWE to drive innovation and efficiency in drug development.
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Simplifying The Regulatory Submission Process With A Modern CTMS
Working in collaboration with industry representatives, explore the value that pulling the regulatory submission process into a modern Clinical Trial Management System (CTMS) could have.
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What Everest Group's RTSM Recognition Means For The Industry
RTSM is transforming from a basic operational tool into a strategic driver of trial efficiency. Learn why industry recognition signals a new era of innovation and competitive advantage.
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FDA Guidance Has Implications For EDC And EHR eSource Capabilities
Gain insight from an eSource study observing digitally received data as far back as 2007 to just before initial guidance was released by the U.S. FDA in 2013.
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Paperless Online Remote Source Document Verification
Learn how Clinical Trial Organizations, Monitoring Teams and Clinical Sites can benefit from the way Judi transforms rSDV from a logistical hurdle into a strategic asset.
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Digital Protocols Are At An Inflection Point: A Conversation With Novartis And TransCelerate Leaders
Digital protocols could reduce manual effort and enable rapid and more consistent downstream study execution, reporting, and submission processes. TransCelereate BioPharma's Rob DiCicco and Novartis' Bill Illis explain.
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EDC Powers End-To-End Data Management In Pharma-Sponsored Trials
As clinical research moves toward adaptive, decentralized, and data-rich models, EDC remains the backbone that makes innovation operationally feasible.
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RECENT NEWSLETTERS
- 02.12.26 -- How Can AI Change Computerized System Validation?
- 02.05.26 -- Digital Tools Are Failing Patients: Three Ways Clinical Supply Protects Data
- 01.29.26 -- Digital Protocols Are At An Inflection Point: A Conversation With Novartis And TransCelerate Leaders
- 01.22.26 -- The Role Of Open Source In Powering CDISC 360i
- 01.15.26 -- Why Ambient AI Is The Missing Link In Clinical Trial Data Integrity