In the News
How Interested Is The FDA In Real-World Evidence?
Radek Wasiak of Evidera comments on real-world evidence in part three of this three-part series.
Dr. Susan Atkinson: Practical Innovator
Read about Susan Atkinson, Ph.D., senior vice president of global biometrics, who was named to the 2017 PharmaVOICE 100 list of the most inspiring people in the life sciences industry.
Parallelism experiments: pros and cons
Jing Tu and Patrick Bennett discuss available approaches that can be used to assess key assay parameters for pharmacokinetic and biomarker ligand-binding assays.
An overview of major reforms in China’s regulatory environment
Alistair Davidson and Bill Wang analyze the potential impact of a series of regulatory changes and improvements on clinical development in China.
Standard data, extraordinary innovations in clinical trials
Tammy Jackson discusses the innovative application of CDISC SDTM standards in clinical trials.
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.
