In the News
De-risking master protocol implementation
Brian Barnes and Rachael Song provide an overview and discuss the benefits of master protocol studies.
GLPs: Better data access needed to improve compliance
Stuart Jones shares his thoughts on good laboratory practices best practices.
Risk-based quality management: The importance of risk communication
Brian Barnes and Volker Hack discuss the ongoing efforts to encourage the implementation of improved and more efficient approaches to clinical trials.
PPD unit Evidera buys up real-world evidence company Medimix
The addition of Medimix will enhance Evidera’s ability to leverage data to provide real-world evidence and insights for clients.
ICH E6 R2 – Best practices for implementing a more formal risk management process
Volker Hack and Brian Barnes discuss how to undertake a well-balanced approach that applies critical thinking and implements lessons learned.
Biotech Booms in the Yangtze River Valley
Daniel Burch looks at the forces shaping the course of biotech growth in China.
Overcoming challenges in immunogenicity method development for peptide therapeutics
Heather Myler, Robert Kernstock and Janine Micheli discuss the unique challenges of peptide ADA assays.
A study of leachable silicone oil in simulated biopharmaceutical formulations
A team of PPD Laboratories GMP lab employees write about the potential effects of leachable silicone oil on large-molecule APIs and the need to establish a robust analytical method to detect and quantify the substance.
PPD’s Evidera acquires RWE provider Medimix
Medimix provides a real-world evidence service offering that includes access to patient-level data, data analytics and visualization capabilities.
