Pharmacy Coordinating Center Business Cases
The Challenge of 100% Accountability for Medical Devices
The Problem
An international medical device company needed 100% accountability for every component of its specialized medical device kits. It had been trying for nearly five years to achieve such accountability on its own with no success.
The Situation
This device was packaged with several ancillary items in a “pizza-sized” box. The client shipped domestically and internationally and needed to track every item within a clinical research environment to meet FDA regulations.
PCC's Solution
We customized our proprietary Tracking ID program (TID) to track the devices, their components and the boxes in which they came, and we assigned the TIDs to the patients who received a specific kit. We further customized the TID to auto-generate customs paperwork for international shipments. Furthermore, kits were randomized within the clinical trial and every box was sealed to be tamper proof.
Results
This medical device manufacturing client achieved 100% accountability for every stent component, which helped to ease regulatory approval by the FDA.
The Challenge of Managing Donated Medicines for Large, Multi-Site Trials.
The Problem
Twenty pharmaceutical companies agreed to donate their medicines for a multisite, blinded, 10-year clinical trial, but those medications arrived in various forms, such as huge drums, pallets of commercial product, or were ordered from the VA wholesaler. Such an arrangement is inexpensive for the donors, but challenging for the academic sponsor, who must repackage, blind and track each package and its contents.
The Situation
The sponsor was testing an intensive versus standard of care treatment strategy in Type II diabetics, targeting HbA1C, blood pressure and hyperlipidemia. Open label medications (and one blinded medication) were used to treat participants to achieve their assigned treatment goals. These products needed to be repackaged and/or labeled for distribution to 100+ clinic sites. Finally, study medications and supplies had to be tracked across 10,000 patients over the course of ten years at 100+ clinics across the US and Canada.
PCC's Solution
We harnessed our Baldrige-award-winning processes for project management, inventory management, product intake, processing, and distribution of enormous quantities of medications and supplies to clinic sites Finally, we used our proprietary software for imprinting ID information on each package and tracking the contents of individual packages to specific patients.
Results
We achieved three goals for our sponsor. First our ability to receive, repackage and distribute huge amounts of medicines saved over $100MM for the study. Such a savings is an incentive for future donations and a boon to cash-strapped academic sponsors. Second, our proprietary tracking system helped the sponsor link medications to participants, track safety signal events for donors for FDA reporting, and determine adherence. Finally, we furnished complete accountability for the pharma partners and clinical trial partner, helping them close their own regulatory loops and obtain the data needed for compliance.