In the News
Marketing applications for biopharmaceuticals: Considerations for different jurisdictions – Part 1
In this two-part series, John Watkins and Clare Ryder highlight the similarities and differences in global submission requirements.
Why You Should Care About Real-World Evidence (A Lot)
Radek Wasiak of Evidera comments on real-world evidence in part one of this three-part series.
Functional Service Partnerships: A Case Study for CRO Resource Management
In this article written by Denise Moody, Tim King and Ranjit Bains, the authors review an FSP in which PPD reduced a client’s annual operational spend by assuming responsibility for clinical monitoring and site support.
Real-World Evidence & The 21st Century Cures Act — What You Need To Know
Radek Wasiak of Evidera comments on real-world evidence in part two of this three-part series.
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.
