Fri, 27/10/2017 - 06:10
Current Issue 59
Clinical Research Innovators
Fisher Clinical Services South Africa is the innovative industry leader in clinical trial research and serves as the gateway to sub-Saharan Africa for global pharmaceutical and biotech companies
Writer: Phoebe Calver
Project Manager: Callam Waller
The globally renowned Fisher Clinical Services’ South African facility is going from strength to strength in the pursuit of clinical trial excellence, working with regulatory authorities to ensure compliance in all aspects of its processes.
In August this year the Company became the first clinical trial supply chain and logistics provider in the area to receive a licence to perform secondary packaging and labelling for clinical trials, cementing it as the provider of choice in South Africa for a broad range of clinical trial services.
South Africa is increasingly becoming a target for multinational pharmaceutical and biotech companies and with thanks to Fisher Clinical Services’ well established reputation with the Medicines Control Council (MCC), it has played an instrumental role in the development of clinical trials in the region.
Fisher Clinical Services cGMP (current Good Manufacturing Practices) Distribution facility was set up in 2009, operating for the first three years to establish itself in the local market before taking its successes with the first of several expansions in the latter part of 2012 and into early 2013.
“We set up the Company in one of four business units that could be used as independent offices and temperature controlled warehousing space,” begins Dennis Bode, General Manager of Fisher Clinical Services South Africa. “When we launched our expansion in 2012 into cold and ambient storage, we required more space and took on the second unit in the business park.”
During this time, the Company was one of the main drivers behind the sponsored growth of clinical trials in South Africa and with that mutually beneficial relationship Fisher Clinical secured the third business unit.
“In 2015 fit out of our cGMP secondary packaging and labeling facility commenced,” adds Bode. “There was further expansion into Unit 4 in 2016 to accommodate cold chain and ambient storage and distribution requirements and office expansion.”
Supporting clinical trial growth in Africa
“It is important to understand what is driving clinical studies both at home and around the world; that way we are able to deliver a service that our clients will gain maximum benefit from,” continues Bode. “We look outside of the normal ideas for storage distribution, instead focusing on what might attract sponsors into South Africa and Africa.”
Secondary packaging and labeling has been one of the main areas of the Company’s improvement strategy, looking at the needs in sub-Saharan Africa to facilitate distribution into Africa and ultimately the needs of pharmaceutical companies looking to grow their clinical studies in South Africa and Africa.
Throughout our expansions and time in the local market, we have seen local growth when it comes to clinical trials and ultimately the work we carry out with both local and international pharmaceutical and biotech clients,” explains Bode. “We found that studying the global markets had a direct correlation to the local market and inspired us to provide an even more efficient service.”
In the present day, the vast majority of the Company’s work involves time and temperature sensitive materials, and subsequently Fisher Clinical Services has ensured that its work across the supply chain is carried out at global, recognised clinical cold chain standards ensuring critical patient treatments are maintained within prescribed temperature ranges.
Ensuring patient safety
Quality products are the cornerstone of the Company, driving every aspect of the business and have led to Fisher Clinical Services having an unmatched quality system in the local market.
All of the processes within the Company’s remit have been carefully adapted over time to achieve the highest possible quality, control and compliance standards to ensure patient safety. These processes have been extended to key partners to ensure 100 percent compliance across the entire supply chain, end-to-end.
Bode adds: “In order to achieve this ongoing growth, we have always had a continuous improvement mentality within the Company where employees follow our Product Process Improvement (PPI) process. That way we can rest assured that they will make recommendations if they feel something could be done in a better manner.
“We have been involved in global and international studies to help improve all aspects of quality within our services and through that have created an environment whereby we focus on achieving low cost with unmatched quality systems in a high performing clinical cold supply chain.”
Ever-increasingly one of the most important aspects of the business is the people within it; everything at Fisher Clinical Services is people driven and it is therefore vital to have the right people at the helm.
“From a recruitment point of view, our main focus is on looking at the character and finding a person that has passion for the subject,” affirms Bode. “Each of these people has a drive instilled within them naturally; that we know we can work with and develop. Our mantra is ‘We Supply Hope’, one that is embraced by all employees.” The Company carries out an extensive amount of training with its people and monitors their performance consistently to ensure they receive the required support they need to effectively carry out their jobs.
The Company runs an induction programme with regular training and assessments to guide each new employee. Alongside that its learning laboratories provide them with hands-on experience of what it will be like in a real cGMP environment. Although they technically work for Fisher Clinical Services, there is a definite feeling within the Company that Management work for them. Ensuring that they always have the knowledge, skills and training to carry out their work in a zero failure environment.
“Finding the right people can take us a lengthy amount of time,” continues Bode. “We expect each employee to deliver 100 percent daily, there is a very special type of person that is able to perform at these high standards within the job; they are the people that we want to work with us.
“With the right team and the years of innovation to support us, we believe that the Company has everything in place to encourage sponsors to come to South Africa and work with our team,” concludes Bode. “I have no doubt that moving forward there will be an expansion in South Africa as more and more pharmaceutical and biotech companies choose this region to conduct their clinical trials, and I hope that it will spread further afield across the continent.”