Speed, agility and funding are common topics among clinical supply teams. And while there are a number of ways to secure funding for a focused study, there is no way to buy more time. However, one can look for a more agile clinical supply source.
Until recently, clinical trial supply managers had only two options for controlling these conditions. One - keep all the logistics and supply management in-house, effectively becoming a distributor for the trial subjects, with all the headaches and regulatory hassles that ensue. Two - partner with a supplier or pharmacy to provide non-IMP medications and supplies to the trial subjects, but then leaves supply managers stuck with the administration and management required for reimbursements, insurance, risk and cost through the life of the study.
To put it simply, neither option is ideal. Both can be frustratingly time-consuming, inefficient, and more costly than necessary.
The RxStudy Card is a first-of-its-kind, direct-to-patient clinical trial supply management solution that puts supply managers' three top concerns - speed, agility and cost - at the forefront. Developed by RxSolutions out of Raleigh, North Carolina, the RxStudy Card gives trial subjects the freedom to choose their own pharmacy from which to acquire their non-IMP drugs and supplies, thus eliminating the need to manage reimbursements and other headaches such as procurement, storage, shipping, temperature excursions and expiry date management.
As clinical trials are designed and subjects are recruited, the formularies of necessary non-IMP medications and supplies are designed as usual. But instead of sourcing those directly, those formularies are simply turned over to RxSolutions. It then customises a programme for each specific clinical trial, complete with study specific 'insurance-like' RxStudy Card that is provided to subjects with a prescription. Subjects receive the IMP trial drugs from the clinical trial supply team, of course, but all of their other drug therapies and supplies are acquired at pharmacies convenient to them with no out of pocket cost. There is no need to travel to the investigational site, which means they are more likely to adhere to the trial protocols, which makes it more likely for trials to be completed successfully and on time.
Wondering if it really works? Consider these two real-world case studies:
In Case Study A, an oncology trial required a standard of care medication that was extremely limited in production. Bulk sourcing was a significant roadblock that threatened to end the study before it began. RxSolutions worked directly with a speciality pharmacy to provide the required medication directly to patients via a central pharmacy, effectively green-lighting the study while also saving 34% - in this case, $58 million - over the traditional bulk supply method.
The problem in Case Study B was a bit different. In this case, the trial sponsor made a significant initial capital investment only to face slow enrolment. So slow, in fact, that the expiration date passed on $1 million worth of inventory before it could be used.
Hesitant to make that mistake again, the sponsor instead partnered with RxSolutions to provide trial subjects with an RxStudy Card, allowing them to obtain non-IMP medications directly from a retail pharmacy, where expiration date management is already systemised. No upfront investment was needed, and there was zero waste.
RxSolutions provide free consultation and analysis for anyone who thinks that the RxStudy Card may be the answer for their next clinical trial. With case studies and data to back up its claims, it's easy to see why the RxStudy Card is a true game-changer in the world of clinical trial supply logistics and management.
