Modern clinical trials increasingly rely on technologies to help accelerate startup, capture endpoints, and facilitate recruitment. In the midst of this technological revolution, it becomes increasingly important to understand patient perspectives and to anticipate how subjects in research studies may be impacted by the presence of digital tools, devices, and mobile health applications in clinical research.
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What You'll LearnMost Recent Flipbooks
Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing ev
This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled “The Role of Endpoint Adjudication in Medical Device Clinical Trials”.
Clinical event adjudication in cardiovascular device trials: An Food and Drug Administration perspective
In this issue of the journal, Jonathan Seltzer presents an important review of the rationale and best practices for event adjudication in medical device clinical trials.
Site-specific, Patient-centered and Whip-smart: Enrollment Assistants Adapt to a Shifting Landscape
In this paper, 17 WCG thought-leaders provide insights on what they anticipate in 2019 in clinical trial technology, regulatory changes, and scientific developments.
Finding New Solutions to a Current Unsustainable Model of Clinical Trial Contracts & Budgets
Genetic Counselors at the Forefront of Helping Researchers Brace for the "Silver Tsunami" of CNS Disorders
An aging population is triggering a “silver tsunami” of neurodegenerative diseases like Alzheimer’s and Parkinson. At the same time, precision medicine holds great promise for many CNS disorders.
Precision Medicine: A Glossary of Terms
As genetic testing becomes an integral part of clinical development programs, understanding the key terms and definitions is essential for all members of research and clinical development teams.
Studies show clinical trial participants want to know what was learned from their involvement. Many sponsors are implementing plans to deliver plain language summaries to trial participants.
Written Procedures for IRBs: What Does the New Final Guidance from FDA and OHRP Mean to You?