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A Small Company’s Experience Managing Safety and Risk Mitigation Without Infrastructure Spend
Optimizing Global Safety Reporting in Clinical Trials
Learn how a large, global pharmaceutical company saved millions of dollars by optimizing their safety reporting process.
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.
Managing the Unmanageable: Meeting the Challenge of Appropriate Safety Report Distribution
Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharrmacologic trials
Clinical event adjudication in cardiovascular device trials-FDA Perspective
Use of Endpoint Adjudication to improve the quality and validity of endpoint assessment for Medical Device Development
Responsibilities of Data Monitoring Committees: Consensus Recommendations
Finding an Agile PV Partner for Early-Stage Clinical Development
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.
Safety Reporting: It Can Enter the 21st Century, If We Let It
DMC Regulations May Change, but Principles Won't
Ebola Outbreak and Earlier Mishandling of Infectious Agents at Federal Laboratories Highlight Importance of Biosafety Programs
Safety Reporting in the 21st Century
Understanding the Challenges of Managing Combination Product Safety Reporting
About WCG Biosafety
Drug Safety Executive Summary eBook
Product Safety Overview
WCG SafetyView Report: Global Automation