OUTSOURCING SUPPLY OPERATIONS T


o outsource or not to outsource? That is the question that every pharma and biotech company asks itself when drawing out the blueprint for its clinical trial


operations. Choosing the right external vendor, whether it is a contract research organisation (CRO), a contract manufacturing organisation (CMO), or any other service provider is like choosing the right business partner. Once, it was popular to outsource all


operations to external vendors, and many companies have reduced the majority of internal capabilities to the bare minimum, says Emma Forrest, head of clinical operations and project management at Recordati. However, there has been a shift in the


industry to gain back control. Some companies invest and build internal teams, while others outsource only certain parts of their operations, creating a feeling of control. The Covid-19 pandemic has also changed the CRO and sponsor dynamic, as previously reported by Clinical Trials Arena. Clinical Trials Arena spoke with small- and


mid-sized companies about their experience with external vendors, and how to choose the right path at the tipping point of outsourcing.


Full outsourcing model is out of fashion One of the reasons many companies have changed their mindset about the full- outsourcing model is CROs losing their vision about why they are in the business in the first place, says Forrest. “They have become much more money-focused and more about ‘who is responsible or accountable for what’, instead of the objective to get medicine to patients as quickly as possible,” she adds. Indeed, CROs might see a clinical trial as another task that needs to be ticked off. CEO Steve Reed says that HDT Bio tries not to completely depend on CROs because for them, it might just be another project. “For us, it is our passion, and nobody will take it as seriously or have as much interest as you do,” he adds. As such, the change in focus is one of the reasons the quality of work from CROs has greatly reduced, Forrest notes. Additionally, there has been a high turnover in CROs, resulting in less stability in the


14 | Clinical Trial Supply Handbook


organisation, which also affects the quality of work. Dr Paul Lammers, CEO at Triumvira Immunologics, says nothing is more frustrating, especially for a small biotech, than dealing with personnel turnover while depending on the external organisation to deliver the project. Because new people need to be trained and


brought up to speed, this can cause delays in the clinical trial. “It’s always frustrating depending on other people, whether it is outsourcing the clinical trial, testing or manufacturing,” Lammers says. As the full-outsourcing model is already very


expensive, continuous delays also mean additional lost revenue, Forrest says. She adds that CROs have created highly locked-in systems, which are made up of tools and people that are virtually impenetrable. “They give hundreds of reasons for delays, and you feel like your hands are tied,” she adds.


Smaller vendors and hybrid model As full-service CROs are going out of fashion, companies are turning towards hybrid outsourcing approaches by choosing smaller or boutique CROs to take care of certain parts of the trial while building internal capabilities. Lammers says that Triumvira has pulled back


some of the company’s sourcing to big CROs and instead started using smaller service providers for some parts of clinical trials such as data management or safety reporting. “It is more convenient, and we have a feeling that we have more control,” he explains. Recordati desired to have more control over its clinical trials after the company decided to


“It’s always frustrating depending on other people, whether it is outsourcing the clinical trial, testing or manufacturing”


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