South Africa has been a target country for many multinational pharmaceutical and biotech companies in recent years. Its well established clinical research industry with a Medical Control Council that operates to FDA and ICH standards, as well as its high patient population and low cost trials, has led to an increase in clinical trials in the region. Serving as a gateway to Sub Saharan Africa, this large patient population is ideal for clinical trials studying bacterial and fungal diseases, cancers, immune system and respiratory tract diseases.
Established in 2009, Fisher Clinical Services South Africa has recently expanded to accommodate the needs of our clients, serving the large clinical trial patient population of South Africa and Sub Saharan Africa. We invite you to find out more about our facility.
Dennis Bode, General Manager, Fisher Clinical Services, South Africa
Fast Facts on the Region:
Presence on the African continent and hub for Southern Africa
Pretoria Fast Facts:
Location: Northeast South Africa
Population: 2.3 million
Nearest Airport: OR Tambo International
Distance from Airport(s) to Facility: 45km
Fun Fact: Kruger National Park in South Africa supports the greatest variety of wildlife species on the African continent.
Key Benefits for Sponsors:
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 exisiting 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.
South Africa has been a target country for many multinational, pharmaceutical and biotech companies in recent years. Its patient population for diseases prevalent to the region such as bacterial and fungal diseases, respiratory tract diseases including tuberculosis, malaria and HIV/AIDS and to other diseases such as cancer, hypertension and diabetes attracts Sponsors to this region. Its mature investigator site staff and the high awareness of clinical trials serves to present a patient pool that is relatively easy to recruit. In addition, South Africa can serve as a gateway to sub-Saharan Africa extending that patient pool even further.
South Africa presents many regional challenges for Sponsors running clinical trials as the patient pool extends out to less well developed areas of the country, and indeed sub-Saharan Africa. The importance of a secure supply chain cannot be underestimated.
Cold Chain Complexity Product safety is of paramount importance when transporting clinical trial materials from point of dispatch to the investigator sites. The increase in cold cain clinical supplies presents additional challenges particularly when transporting supplies throughout South Africa and sub-Saharan Africa where the climate is tropical, often reaching high temperatures. To meet expected cold chain conditions across the supply chain a provider needs to create a network of refrigerators, cold stores, freezers and cold boxes so that the clinical supplies are maintained at the right temperature during transportation, storage and distribution up until the point of use at the investigator site.
Regulatory Procedures Many emerging markets, faced with a sudden influx of clinical trials, are addressing the need to establish or evolve regulatory infastructures. Africa is further complicated in that there are many regulatory bodies involved in importation and exportation of clinical trial materials. It is important for companies to keep up-to-date on the latest regulatory requirements and documentation expectations so that shipments are not compromised during transit to the investigator site. Incorrectly prepared documentation can cause significant delays along the supply chain, putting the clinical trial in danger.
Delivering to timelines Our client, a multinational pharmaceutical company, had many countries included in its clinical trial, one of which was Tanzania. A number of critical ambient shipments were scheduled for delivery to Mbeya in Tanzania with an expected delivery time of 2-3 days.
Customs clearance Custom port authorities in Tanzania are entitled to stop 10% of all shipments entering Tanzania. This particular shipment was stopped for documentation and physical inspection.
Due to the sensitivity of the medication and the potential to compromise the contents if the shipment was opened or handled incorrectly, it was important that the clearing agent was present with customs officials for the physical inspection of the goods. The Fisher Clinical Services South Africa team with their selected freight service provider communicated directly with the clearing agent and the customs officials to ensure that defined client procedures were followed correctly.
Delays In this instance by the time customs officials had cleared the shipment all scheduled flights to Mbeya had departed. To ensure patient visits were not compromised the Fisher Clinical Services team took the decision to arrange alternative overnight transport via road to ensure delivery of shipments the following day. The investigator site was advised of the change in transportation method, and the new, revised delivery schedule was communicated to the investigator site.
Meeting investigator site expectations The investigator site confirmed that all medication had been received On-Time, In-Full and fit for purpose. The trial continued, as scheduled. All patients received their medication on time.
Access to patient pool Fisher Clinical Services South Africa continues to update its database of regulatory requirements for all countries, facilitating access to that important pool of patients in South Africa and sub-Saharan Africa.