Pharmaron

David Lew

Clinical Development Authority

Contract research organization (CRO) and Sponsor partnerships are essential in clinical development. Outsourcing clinical development to a contract research organization (CRO) can significantly accelerate the time it takes to bring a new therapeutic to market. A new therapeutic can be a drug, biologic, medical device, or some combination of them, which can also be referred to as an investigational product (IP). There are many benefits to accelerating IP development, but one of the most important is the benefit to patients and public health by enabling access to new treatments sooner.

Faster clinical development also gives the clinical trial sponsor companies more time on their patents’ exclusive rights to market their product to recoup research and development costs, and gain revenue to fund further clinical development (e.g., into other indications) and/or other products. That is assuming that regulatory approval is granted after safety and efficacy is proven in the clinical trials. But if the product is proven to not be safe and effective in those clinical trials, then the sponsor can find out and proceed accordingly sooner. For these reasons, over 70 percent of clinical trials are conducted by CROs. And CROs are even more frequently utilized for late phase (e.g., Phase 3) global clinical trials that involve many study sites to recruit and enroll hundreds or thousands of study subjects.

While sponsor and CRO partnerships are prevalent, the exact services a sponsor utilizes from a CRO can greatly vary. A sponsor may outsource anywhere from very limited to nearly all aspects of a clinical trial, with the latter involving a ‘full service’ CRO that may provide all services for the planning and execution of clinical trials, with the sponsor only providing oversight. Some examples of functional service areas that a CRO may provide include project management (which may consist of vendor management, trial master file (TMF) management), study start-up (which may include identifying, selecting, and initiating multiple sites across multiple regions of the world for a multicenter clinical trial), clinical operations (which may include site management, clinical monitoring and conducting other remote and/or on-site visits), regulatory affairs, medical writing (which may include clinical protocol development), medical affairs (which may include Medical Monitoring), pharmacovigilance (PV or safety), data management, biostatistics, and other aspects of clinical trial management.

"The general rule of thumb is to select a CRO that is proportionately sized to the size of the sponsor company"

The service needs between sponsors may significantly vary depending on many factors, but generally, there are some fundamental differences between emerging biotech versus large pharma companies. The smallest of emerging biotechs may have limited experience in clinical development, so a CRO can work extremely closely with them to provide consultations and guidance, in addition to providing the various specialists and experts needed for all aspects of clinical trial design and execution. A CRO can provide expanded capabilities to a small biotech, whereas a CRO can provide expanded capacities to a large pharma. A large pharma may already have experience and expertise in-house but is looking for experienced clinical research professionals to augment their own teams. Clinical trials often involve a very high number of team members, so CROs can offer scalability to Sponsors. The general rule of thumb is to select a CRO that is proportionately sized to the size of the sponsor company. That is, small companies work with small companies, and large with large. But that is not necessarily always true, as there are numerous factors for a Sponsor company to consider when selecting a CRO.

CROs greatly vary in many ways, including size (i.e., small, midsized, large), geographical reach (i.e., having experience with regulatory authorities across different countries, local staff, and resources), therapeutic area expertise/focus (i.e., there are CROs that specialize in only oncology clinical trials), and development phase focus (i.e., early phase versus late phase). There are some CROs that are more niche and focus on certain limited aspects, and there are also large CROs that have the expertise to do it all. That is just a limited sample, but there are numerous factors for a Sponsor to consider when selecting a CRO. Ultimately, service cost is often an important consideration. But relevant expertise and experience and anticipated timelines are important factors. One less often mentioned factor is the proposed team that a potential CRO offers to a Sponsor, which can significantly vary even within a CRO (i.e., in terms of experience, communication, and collaboration style).

Selecting a CRO is in some ways more like an art than a science for a sponsor, although when analyzed factor by factor, then weighing the importance of those factors, it often ultimately is clear which may appear to be the best CRO partner for a Sponsor at that time. The best way to arrive at that decision and conclusion is to have discussions and bids from multiple CROs, starting broadly and eventually narrowing down. CRO and sponsor partnerships are important in clinical development, and it is important for a sponsor to carefully select the best CRO for their exact needs.