Thought Leadership
Blog & Article
- 17th May 2023
Journal Article
Trial master files were long treated as an archive repository for all documents related to a clinical trial. That approach doesn’t properly reflect the evolving story of a study, which will go through a variety of changes and milestones throughout the product lifecycle and across different study regions.
Video
Get to Know Mark A. Lane, PhD, VP of Development & Scientific Affairs
Blog & Article
- 24th October 2022
Journal Article
The upheaval wrought by the COVID-19 pandemic has had a silver lining for researchers and participants in decentralized clinical trials (DCTs), giving rise to a transformational philosophy more attuned to the needs of the patient.
Journal Article
This article explores how Bayesian statistics make it possible to take observations made during the validation of the analytical procedure and predict the uncertainty around any future result, and in doing so, bridge the gaps that exist in the guidelines.
Journal Article
With both the cost and time to bring a drug to market ballooning, the importance of an integrated product development (IPD) strategy is gaining traction. This multidisciplinary approach to drug development brings key stakeholders together, breaking down barriers to an e!cient and cost-e”ective path to market. But while more organisations are adopting an IPD strategy, a recent industry survey found most aren’t doing so early enough. Frédéric Pailloux, Senior Director, Head of Integrated Product Development and Consulting at PharmaLex examines the IPD journey.
Journal Article
After nearly six months of war, life for patients in Ukraine continues to get harder. The World Health Organization (WHO) has reported that people’s health has been imperiled by difficulty in accessing emergency care and essential medicines. Dr. Hans Henri P. Kluge, WHO Regional Director for Europe, noted that there had been more than 260 verified attacks on healthcare in Ukraine by early June, resulting in some health facilities being destroyed and others struggling to cope with people seeking care from trauma and injuries.