In the News
The Changing Role of the CRO and its Effect on Project Management
Volker Hack and Denise Sackner write about the impact of increased clinical trial complexity on project management.
Troubleshooting Lab Operations: Be Proactive, Not Reactive
Chris Forsdyke reviews systems and processes that enable a laboratory to approach troubleshooting in an effective way.
Contamination Control and Environmental Monitoring Program Results
Peter Wunderli, Jon Denissen, Maggie Bach, Moira Elmore and Erica Golueke discuss the results of a monitoring program at a GMP QC cell-based (bioassay) lab, along with a risk analysis and their recommendations.
Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions
In this article, Monika Jain discusses the issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products.
CROs and Next-Gen Drug Development
PPD's David Johnston comments on the new operational, organizational and partnership-based approaches to drug development.
Solid-Phase Extraction for the Preparation of Aqueous Sample Matrices for Gas Chromatographic Analysis in Extractable/Leachable Studies
Steve Zdravkovic outlines the attributes of solid phase extraction and the advantages it offers compared to liquid/liquid extraction.
PPD forms new unit with Evidera, MARO teams
Outsourcing-Pharma reports on combination of PPD’s medical affairs research operations and Evidera.
PPD combines medical affairs team with real-world research subsidiary Evidera
FierceBiotech reports on combination of PPD’s medical affairs research operations and Evidera.
Movement for real-world evidence as PPD and Evidera launch new research unit
CenterWatch reports on the combining of PPD’s medical affairs operations team and Evidera.
