In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.
Experience has shown the transition from active shippers to passive shippers is mainly driven by three factors: cost-savings, availability, and ease of use.
The complexity of drug product supply chains has increased in recent years thanks mainly to the development of more complex chemical molecules and reduced average production volumes.
The concept of cold chain shipping is decades old, but it wasn’t until the last several years that industry has seen great advances in technology, processes and standards for moving temperature-sensitive products. By Joe Reedy
How good is your supply chain performance? Many suppliers perhaps believe theirs is pretty good; however, it seems each year when businesses are surveyed by the numerous supply chain consulting firms and trade magazines, visibility usually ranks at the top of the list as an area for improvement. Indeed, the typical supply chain has become much more complex over the years as manufacturing expands to Asia, South America, Africa, and so on.
A US biopharmaceutical company approached Almac to assist with the EU product launch of their high value, orphan drug product. As the drug product was temperature sensitive with minimal allowable temperature excursions a key deliverable of the project was to design and qualify a temperature controlled shipping solution to ensure delivery of the production optimum condition. Throughout this case study Almac will highlight the challenges that arose and will provide solutions on how these challenges were overcome to facilitate a successful product launch.
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.
TrialMax Web™ is a web-based diary specifically designed for late phase trials, which tend to be larger and longer in duration.
World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.
