AUGUST 2023LIFE SCIENCES REVIEW8IN MY OPINIONontract 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 CBy David Lew, Senior Director, Clinical Research, PharmaronCRO AND SPONSOR PARTNERSHIPS IN CLINICAL DEVELOPMENTthem, 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. David Lew
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