Other content in this Stream
A Small Company’s Experience Managing Safety and Risk Mitigation Without Infrastructure Spend
Understanding the Challenges of Managing Combination Product Safety Reporting
5 Benefits of Outsourcing Expert Committee Management to an Independent Provider
Due to evolving practices and increased regulatory attention on Expert Committee operations, trial sponsors are benefiting by outsourcing committee management functions to an independent provider.
Finding an Agile PV Partner for Early-Stage Clinical Development
Optimizing Global Safety Reporting in Clinical Trials
Learn how a large, global pharmaceutical company saved millions of dollars by optimizing their safety reporting process.
How Roche Optimized its Global Safety Reporting Process for Clinical Trials
Roche recognized several major challenges that its CTSP 2.0 system needed to address.
Unique Challenges for Medical Device Clinical Trials
Adjudication of events of interest can support overall study integrity and ensure reliable, consistent definitions are provided to regulators and the scientific community.
Safety Reporting: It Can Enter the 21st Century, If We Let It
Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharrmacologic trials
Global Osteoarthritis Program facing FDA Safety Concerns
Clinical event adjudication in cardiovascular device trials-FDA Perspective
Managing the Unmanageable: Meeting the Challenge of Appropriate Safety Report Distribution
Responsibilities of Data Monitoring Committees: Consensus Recommendations
This article provides a practical guide to sponsors, institutions, and individuals responsible for, or serving on, a DMC.
DMC Regulations May Change, but Principles Won't
Ebola Outbreak and Earlier Mishandling of Infectious Agents at Federal Laboratories Highlight Importance of Biosafety Programs
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.
Small Biotechs, Big Safety Data Responsibility
About WCG Biosafety
Drug Safety Executive Summary eBook