Help sponsors design a more holistic strategy to their managing the clinical supply returns process.
World-class logistics facilities with state-of-the-art IT infrastructure implement new monitoring system allowing real-time monitoring and data recording, and meeting the requirements of FDA 21 CFR Part 11.
A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.
The global pharmaceutical sector is embarking on a transformational journey in which the supply chain will play an increasing strategic role. There will be a need for greater agility and speed to market.
To maintain the proper temperature of vaccines, West Pediatrics relies on Bluetooth low energy (BLE) data loggers for accurate and reliable temperature monitoring.
Europe and the United States are considered the world leaders in the safest pharmaceutical markets for patients. However, the US and Europe are also a lucrative target for drug crime.
For most pharmaceutical companies, a key challenge is the ability to create and maintain an innovative and competitive distribution channel strategy.
Understand certain study characteristics can act as useful leading indicators of future clinical supply challenges, allowing clinical sponsors to take a proactive rather than reactive approach to clinical supplies.
Overview of a parallel formulation feasibility assessment approach that is designed to reveal the most suitable pathway to enhance bioavailability and accelerate development.
Experts outline cell line development, upstream process development and process scale-up for technology antibody programs in which the antibody requires additional conversion by a site-specific enzyme for correct functionality.
How to prepare successful automation programs that allow unparalleled efficiency in method transfer to receiving laboratories.