When a pharmaceutical sponsor adds a new study to its pipeline, there are many things to consider. However, study architects must ask—and get solid answers to—two very important questions in particular:
1) What is the projected total study cost?
2) Do we have enough people to support it?
Clinical trials carry significant financial risks for pharmaceutical sponsors and study managers. Assumed inventory, carrying costs, overages, drug expiry management, temperature excursions, drug recalls, and losses due to damages put enormous pressure on the budget and the study team. When a study is halted before completion due to regulatory or non-performance factors, entire inventories of comparator and support medications and supplies often cannot be returned. These items must be destroyed, leading to unexpected waste of money and resources.
The human resource element is also important to consider. More specifically, what is the headcount required to support the study, in what capacity, and for how long? Will resources need to be pulled from other studies or programs? If positions and responsibilities are not properly allocated, staff can become overworked and frustrated. Adding new employees comes with additional challenges. The processes of screening, interviewing, and hiring candidates requires current key team members to put aside their normal duties to help Human Resources. After new employees are hired, the team must spend a significant amount of time training and onboarding them. These tasks most likely occur near the start of the study, placing additional stress on team members at a critical time. As a result, sponsors may be torn between staffing an undermanned team or saddling that team with hiring and training additional employees and delaying important duties related to the study.
A third study consideration—drug and supply management—impacts both the budget and Human Resources. Study sponsors typically employ an entire supply chain team that is devoted to sourcing and managing study drugs and other supplies needed to meet regulatory requirements. In general, these are commercially available medications that are unblinded to study participants: over-the-counter drugs, comparators, standard-of-care, rescue medications, and ancillary supplies.
Sourcing these medications can be costly. First, the supply chain manager must find everything needed per study protocol, which can push costs up when multiple channels are required to meet demand. Each channel sources from a wholesaler and then marks up its supply cost. Supplies can often come from a wholesaler, who sourced them from another wholesaler, who purchased them directly from the manufacturer. Each link in the chain can increase the overall cost of the products. If a study requires an expensive Limited Distribution Drug (LDD), which may have only three or four nationwide suppliers, the costs can really soar.
The supply chain team is also usually responsible for packaging, labeling, storing, managing inventory and expiry dates, and shipping the drugs to clinical sites. In addition, team members must train site administrators on the receipt, storage, administration, inventory management, and return of unused medications that are sent to the site.
Now that we’ve identified all the challenges facing clinical studies and their managers, let’s discuss the alternative solution.
TrialCard offers a solution that saves study budgets and frees up valuable time for supply chain and study management employees. The RxStudy Card™ is a virtual clinical trial inventory solution that reduces the overall costs of commercially available drugs and supplies, while allowing for the reallocation of resources to other critical projects. The RxStudy Card is used to acquire commercially available medications and supplies directly from retail and specialty pharmacies at better than wholesale pricing. By eliminating the need to source, pack, label, review batch records, ship, and handle the other 20+ steps that go into supply chain management, the RxStudy Card saves clinical supply managers up to 3 ½ weeks of employee time over the course of a trial. For every hour that TrialCard manages the clinical supply process, the clinical supply team can invest one additional hour into another study.
The past two FDA commissioners have challenged study sponsors and CROs to modernize and innovate for greater efficiencies in drug development to help mitigate escalating drug costs. Study sponsors must consider disruptive solutions with the potential for saving on drug development. The RxStudy Card, proven in over 200 clinical trials to date, is the first proven solution to utilize a technology-enabled virtual inventory. The use of a virtual inventory has revolutionized supply chain management for pharmaceutical and biotech companies large and small. When freed from reliance on CMOs and sourcing organizations, supply teams can save themselves time and money by allowing pharmacies to assume the responsibilities, risks, and costs of drug management. In the end, the cost savings that come from dispensing products at better than wholesale prices can’t be ignored.
To learn how the RxStudy Card by TrialCard can improve your supply chain process, please contact us at firstname.lastname@example.org.