Clinical Research: Outsourcing in the Pharmaceutical Industry

Since the start of the 2000s, the whole industry has changed the way clinical research operations are done. In the beginning, the practice was to have a fixed and vertical reporting model, which included a lot of in-house experts who were working on clinical studies. But new trends have emerged.

After that, the industry switched to a combined matrix model that involved both internal and external resources. Finally, the practice which is popular today is to move the whole work in bulk to an adequate CRO (Contract Research Organization).

The main focus of this post will be on showing how it came to this and how these new practices are put into action. We will look at these business processes from the perspective of CROs and how they make arrangements with big pharmaceutical companies.

Way these partnerships work

The relationship between CROs and pharmaceutical companies that outsource their services has become much more important. Consequently, relationship management between the two sides is now a priority, and because of this, there is a greater level of integration between companies that offer clinical trial services and pharmaceutical companies.

CROs are no longer simply service providers; theyare now perceived as a vital part of the whole process of drug development. This makes a huge difference. CRO leaders are now constantly engaged by their partners, and they are involved in making vital decisions that lead to making high-quality products.

As long as the outsourcing partnership is ongoing, CRO and pharmaceutical companies work together on accomplishing the deliverables which were agreed upon and bring the new drugs into the market as quickly as possible.

Phase II has taken the throne from the preclinical phase

To be able to meet their development and research needs, at the moment 75 % of pharmaceutical companies outsource to CROs solely, or to CROs, CMOs and CDMOs combined. Mid-sized and big pharmaceutical companies like to outsource services from combined providers including CROs, CMOs, and CDMOs.

The small and starting pharmaceutical organizations like to outsource their processes solely to CROs. The fact that CROs can deliver successful development and innovation is the reason why Phase II is now the most popular outsourcing process.

Which pharmaceutical companies are suitable partners

There is more and more opportunity to get outsourced by a pharmaceutical company as a CRO, CMO or CDMO. However, it’s essential to find a worthwhile partner and choose a good deal. Given the fact that both sides are now basically equal, it’s important to identify a good pharmaceutical company.

The first important thing when choosing a partner is to see whether or not they are serious about making a long-term strategic partnership. This means that they have aconstant demand for new products and a lot of work to be outsourced. No CMO, CRO or CDMO can afford to look for new partners constantly, without being able to work to their fullest potential.

As a CRO, you also need to ask your potential partner for detailed requirements. The partner needs to have good communication with you and provide you with clear demands. If the communication is not on a high level and they have little knowledge of the clinical trial, your partnership won’t work well.

 

Contract service providers are expanding their business steadily. However, to get better deals and remain competitive, you have to keep improving the quality of your work. Quality is still one of the most important factors for making these strategic partnerships.