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EF: What are the most important things I should know about CROs in South Africa?
NS: A CRO is truly the intermediary between drug development and registration. In the past pharma did most of that work themselves, but less so now. Pharma companies now generally outsource the testing of a compound, which is where CROs are instrumental and play a key role. In a country like ours, where pharma has a smaller concentration, it is more common for pharma to use CROs. This is probably because CROs in South Africa have more access to sites and site networks; they are also very familiar with the processes involving regulators, ethics committees and compliance.
EF: Given that the pharma presence is smaller compared to other countries, can you describe what kind of footprint research has in South Africa?
NS: We know there is a significant contribution, but it is very difficult to get data to prove it because it hasn’t been specifically measured. SACRA (South African Clinical Research Association) has decided this year to derive a way of generating the data required, and to use the metrics needed in order to show the footprint. In collaboration with the Department of Health and SAHPRA (South African Health Products Regulatory Authority), SACRA would like to launch a database to capture timelines and return on investment, etc. In addition, SACRA would like to work more closely with the regulators, pharma and CROs to determine how we can ensure South Africa is selected as the country of choice for their research. We need to become more competitive by collecting and using relevant data. Challenges with funding, submission timelines, export permits, implementation and adherence to new guidelines, sustainability and capacity building of investigators and sites and better collaboration with the regulators need to be addressed by the industry collectively, in collaboration with the regulators.
EF: There are challenges posed for the CRO space, but the CRO market globally is expected to grow, so how would you as a CRO representative in South Africa plan on seizing part of these opportunities?
NS: The patient population in South Africa is quite unique and beneficial to pharma as a significant proportion of the population is research naïve. On the whole, we have a very good regulatory infrastructure. The mix of a large patient population, great regulatory structures and experienced CROs makes South Africa ideally suited for expanding the clinical trial industry.
EF: How does the technology factor into your efforts to make better use of your resources?
NS: There are two very important aspects to using technology in research. The first is internet access, which is improving greatly in Africa. In the past, access to the internet has been a challenge. The other aspect is moving toward capturing our data electronically from the first point of entry, or data source. This would save a lot of time and reduce transcription errors. I think our main challenges in achieving this are upgrading to mobile devices such as tablets, while keeping the devices physically safe and the data on the devices live and secure. We are seeing an increase in the number of medical records produced, with sites having their own ways of managing the data and other logistics. But, with a live electronic system, the overall benefit is real-time access and real-time analysis of the data.
