SpineMark CRO Management, a wholly-owned subsidiary of San Diego-based SpineMark, has signed an agreement with England-based manufacturer of spinal medical devices Ranier Technology to provide contract research support services for the CAdisc-L clinical trial, a 3rd generation lumbar total disc replacement device for treatment of degenerative disc disease in the lumbar spine.
The CAdisc-L design, materials and biomechanics represent a clinical advance in the treatment of degenerative disc disease in the lumbar spine. SpineMark CRO Management provides site recruitment including utilisation of principal investigators from its network of sites, reimbursement strategy development, payor education, trial management and site training.
It also includes patient recruitment, data management, monitoring, regulatory advice and general oversight to allow Ranier to effectively complete their FDA requirements for approval of new spinal devices.
Marcy Rogers, president and CEO of SpineMark, said: “The SpineMark CRO model provides intermediary third party oversight to ensure that the highest quality of monitoring, management and resources can be brought to bear for Ranier, as well as the patients and physicians participating in this trial.”
Geoffrey Andrews, CEO of Ranier Technology, said: “I am delighted to be working with SpineMark. Their specialized dedication to clinical research in spine, their relationships, and their ability to manage various aspects of the US clinical trial process makes them a perfect fit for our study.”
SpineMark offers an international medical advisory board and access to SpineMark’s network of physicians and surgeons across the country. The corporation is an expert in FDA regulations and protocol, offering site operations support and training, contract negotiation and financial management, regulatory and compliance oversight and marketing and media relations.