Overcoming Regional Challenges, to Deliver Clinical Supplies On Time
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 infrastructures. 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.