Clinical Research Organization Services
SpineMark continues to build its network of Spine Research Organizations (SROs) across multiple facilities and SpineMark Centers of Excellence. SpineMark offers unique and complete regulatory, preclinical, clinical, and reimbursement services for spine- and pain-focused clients. A SpineMark SRO provides clinical trial expertise and management for conducting complex studies. In addition, these specialized SROs streamline patient enrollment, centralize data collection, and facilitate positive outcomes for clinical studies.
Since 2006, SpineMark has lead or been actively involved in more than 50 spine research studies with more than 20 medical device and pharmaceutical manufacturers specializing in spine. SpineMark provides strategic advantages, which include:
- One company providing all clinical services
- Access to SpineMark sites to maximize enrollment
- Cost savings through project efficiencies
- Rapid patient enrollment
- Spinal research expertise
- Extensive investigator database
SpineMark is comprised of a specialized team of experts, all of whom have proven track records for successful spine trials across multiple investigative sites. SpineMark is the only company providing ready-to-go, fully functional investigational sites for spinal clinical trials in the U.S. and abroad. These sites are available for immediate enrollment to SpineMark client companies for new trials or ongoing trials needing additional sites.
Benefits to Device Manufacturers
For the device manufacturer, the SpineMark SRO, offers access to surgical specialists, interventional pain specialists and conservative care physicians and provides a seamless, integrated path of care for patients needing spine treatment.
Benefits to Physicians
For the physician, SpineMark’s specialized SRO allows smaller practices to participate in clinical research that was at one time only available to large institutions.
Reaching FDA Approval
SpineMark works with medical companies recruiting for FDA trials, coordinating with the SRO and providing quality assurance. We also implement the appropriate infrastructure to carry out trial protocols, policies and procedures. We provide quality assurance, staffing, tracking and training. We offer an in-office clinical research coordinator to manage the trial and a full-service marketing team, well versed in the IRB approval process, for patient recruitment.