OUTSOURCING SUPPLY OPERATIONS


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


With its pros and cons, outsourcing certain parts of the company, whether it is clinical trials or manufacturing, is simply part of the business


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.


Clinical Trial Supply Handbook | 15


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