First Patient In Dates Met When Sponsor Moves All Trials to Fisher Clinical Services, South Africa
All professionals in our industry know the importance of First Patient In (FPI) dates. To achieve FPI the clinical materials must be provided On-Time, In-Full and fit for use.
In this case study a multinational pharmaceutical company with scheduled FPI dates and with over 20 clinical trials in South Africa realized that their trials were at risk of being compromised. The Sponsor needed to find an alternative provider that could deliver the clinical materials, complete transfer, store and distribute clinical trial materials for all of the Sponsor’s trials in a very short timeframe.
Relocation Planning Process The Fisher Clinical Services team was instrumental in defining a relocation plan to transfer all Investigational Medicinal Products (IMPs) from the existing provider to the Fisher Clinical Services facility. This plan involved the setting up of all components and studies on the Fisher Clinical Services system prior to the re-location of IMPs. This was a comprehensive plan to ensure clinical trial supplies would reach patients On-Time and In-Full, as per the original trial schedules.
Test runs The Fisher Clinical Services South Africa team advised that it would be pertinent to do a number of “test runs” from the existing provider to the Fisher Clinical Services facility. This would ensure that all possible eventaulities were taken into account and would give all concerned parties reassurance that the relocation plan had been thoroughly tested in advance.
Transportation would be conducted in four 8-ton closed vehicles, with all vehicles certified and calibrated for temperature controlled IMPs, as per client product specifications and stability data.
Security All parties worked together to define acceptable security measurements, mitigating risk across the supply chain during this complex transfer of high risk clinical supplies. All clinical materials were collected at a set time from the existing provider and then transferred immediately into solid sided vehicles. These vehicles were locked with high security locking devices before transit. In addition, only authorized staff were permitted to travel in the vehicles; the vehicles were not to deviate from agreed routes; and all drivers had mobile communication for emergency situations.
Quality Assurance During the receipting process, a member of the Quality team at Fisher Clinical Services was on hand to oversee the process. Documentation including Proof of Receipt Letters and Release and Receipt Forms were added to each product log shipped. The Fisher Clinical Services team registered all deliveries on its system and downloaded all temperature data for submission to the client for approval.
Transfer The decision was made to relocate all supplies over the weekend so as to prevent disruption in service to those patients already participating in trials. A pre-defined transfer process was followed. IMPs were loaded and checked against a packing list. To ensure temperature sensitivities were adhered to, all cold chain materials were loaded and checked inside the vehicle. Temp-Tales were placed in the front, middle and rear of the vehicle. The vehicle was secured with a security seal and escorted to the Fisher Clinical Services facility where a team of Fisher Clinical Services staff were waiting to unload the IMPs, to download the temperature readings and to check all IMPs against the packing list before capturing this onto the Fisher Clinical Services system. All cold chain products were offloaded directly into a cold room at the Fisher Clinical Services South Africa facility, and immediately transferred to pre-allocated storage locations without delay.
A patient is waiting All patients participating in this Sponsor’s clinical trials were oblivious to the Sponsor’s switch of service provider. Those with trials in progress received their medication, as expected. Other patients starting new trials received their FPI medication on the Monday after the move. Fisher Clinical Services will continue to services this Sponsor for new studies in the future.