FEBRUARY 2024LIFE SCIENCES REVIEW8IN MY OPINIONBy David Lew, Senior Director, Clinical Research, PharmaronCRO AND SPONSOR PARTNERSHIPS IN CLINICAL DEVELOPMENTontract 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. CDavid Lew
< Page 7 | Page 9 >