Jim Sergi, President CSSi LifeSciences, told us the launch of CSSi LifeSciences Medical Device CRO is a “logical extension” of the company’s life sciences business coupled with CSSi, which provides patient recruitment and site management services, and Nexus, which provides software technology that integrates patient support and access programs on a centralized platform.
“Unlike traditional CROs, we are able to service small to large companies by avoid cost-prohibitive large CRO cost structures, by offering efficient, fully-integrated expertise and services from a design prototype to commercialization,” said Sergi.
According to Sergi, “traditional ‘big-box’ CROs” aren’t able to provide the same services as a smaller organization.
“Often early phase companies struggle with the pathways for a medical device from design to commercialization because of the ambiguity and complexity of the process,” he explained.
Additionally, Sergi explained this process is becoming more complex as the FDA and the EMA have recently introduced new guidance and regulations for medical devices and medical device/drug combinations.
“The preclinical or non-clinical testing requirements for a medical device are becoming aligned with those of drugs,” he added.
Moving forward, the company plans to grow its medical device CRO “in a controlled manner,” Sergi said, as well as look for new opportunities to expand its service offerings.
“More importantly, we are providing new opportunities for our staff to grow and to expand their skills,” he added.