To 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.

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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 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 look at business perspectives with earlier development products that are in Phase II trials instead of relying on late-stage assets, which before ‘de-risked’ the company’s investments. After years of such a business model, Recordati became lean within the clinical development group and needed to define where the company’s time was most valuable to the trial outcome without having too many internal resources.

As such, Recordati chose certain Veeva Systems’ solutions such as the clinical trial management system (CTMS) and clinical data management system (CDMS). This hybrid model allowed the company to monitor clinical trial activity without relying on a CRO. “This allows us to hire smaller and more dedicated CROs, create that relationship and see them as an extension of yourself,” Forrest adds.

Additionally, the new EU Clinical Trials Regulation (EU CTR) triggered Recordati to rethink its risk analysis. With EU CTR, all of the clinical data needs to be made public on Clinical Trials Information System (CTIS), including the protocol, investigator brochure, and every interaction and question with authorities. “If you don’t have full control over that, that’s a huge risk,” Forrest says.

Value in outsourcing

While outsourcing has its cons, there is still value in hiring external vendors to help with the trial. Forrest explains that if a sponsor is conducting large trials in many countries with hundreds of patients, the sheer mountain of operational work that needs to be completed in each country is probably not feasible for most companies. “It makes sense to have the expertise in all those countries, which the CRO does offer,” she adds.

Indeed, relying on local service providers can also help companies bring their products to the countries of interest, says Reed. He explains that in South American or Asian countries, producing the drug locally can cut costs and have greater acceptance through their internal regulatory agencies.

Lammers says that a small company is capable of running a clinical trial alone only if it hires all the people that are required to take care of multiple layers of study conduct. This involves developing a clinical protocol, which is a complex and time-consuming exercise, and working with trial sites, that sometimes tend to over-promise and under-deliver. He explains that CROs have processes and standard operating procedures (SOPs) and know how to get it done.

Finding the right partner

To find the right outsourced partner, sponsors need to do their homework beforehand, Lammer says. “It is easy to say that you will hire a big CRO, which is also beneficial in front of potential investors. But the question is, do you really need a big CRO?” he notes.

Companies should also think about their future. Reed says that sponsors should evaluate their needs based on clinical trial plans over the next months or years. If a company is planning to conduct one trial, then a small team can oversee it easily. But if a sponsor has a pipeline and wants to conduct several trials in parallel, they might need to build internal teams and empower them to work with CROs.

Forrest advises considering where personal interventions bring the most value and benefit the trial outcome. For Recordati, it was the cleanliness of data and the ability to review it. “A lot of trials fail because the data is not clean enough, so it is absolutely critical,” she explains.

With its pros and cons, outsourcing certain parts of the company, whether it is clinical trials or manufacturing, is simply part of the business. “You need to use it, but use it effectively,” Lammers adds.