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WHITE PAPERS AND CASE STUDIES

• A Guide To Patient-Centric Digital Endpoints In Heart Failure Trials

  Unearth the ways actigraphy can objectively measure treatment effects on a variable that drives patient outcomes and prepare trials to better align with the FDA’s position on patient-centric drug development.

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• Long-Term Data Services Partnership Drives Efficiency For A Medical Device Trial Sponsor

  Discover how Abiomed was given access to innovative and comprehensive programming solutions to reduce the need for manual data entry and to enhance the clinical trial database usability and speed.

• Closing The Gap In Our Understanding Of Sleep Health With DHTs

  What is the current state of sleep assessments in clinical trials, regulatory expectations, and what opportunities do wearable digital health technologies present?

• GSK And Medable Discuss The Next Phase Of DCTs

  GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.

• How Syneos Health Tackles Protocol Complexities

  Explore solutions employed by Syneos Health, a global contract research organization, to optimize Phase IIV clinical trials, particularly under a complex adaptive trial protocol.

• Life Sciences Corporation Implements eLogbooks Across 15 Sites

  New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

• The Business Case For EHR eSource In Clinical Trials

  Examine how manual data collection challenges prompted the adoption of an eSource solution that streamlined data entry, saving time and costs, reducing errors, and accelerating a multicenter phase 2 trial.

• Leveraging Machine-Learning For SDTM Mapping

  The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) represents trial data in a standardized format for review, but could its preparation be automated?

• The Untapped Power Of Real-World Data And AI In Pharma Commercialization

  Harnessing RWD in commercialization bridges the gap between approval and patient access, equipping companies with actionable intelligence to deliver life-changing therapies to more patients.

• New Duke Research Shows Participants Prefer Enhanced eConsent

  It’s apparent to those who have used it that the “e” in eConsent could stand for much more than 'electronic'. Duke’s new research shows why participants prefer an eConsent experience bolstered with videos, media, questions, and more.

• Navigating The Privacy Tightrope For CTIS

  Examine the challenges, potential risks, recommended best practices, and future trends related to anonymizing personal data for Clinical Trials Information System submissions.