Outcomes monitoring for your device.
A key factor in outcomes success is the implant or hardware itself, and a well-executed, quality-controlled clinical patient registry can provide valuable insights on the performance of your device on a representative population.
As part of the outcomes monitoring process, we store information on every implant and associated hardware our clinical partners use. While most organisations only record company and device name, we rely on reference numbers so that each piece of hardware can be traced to its manufacturer. This proofs our process from design changes and version updates, and guarantees traceability at all times.
Whether it's a local, national or international body, we can audit an existing database, gather the key information required, and provide a report that meets the key regulatory requirements, These reports are critical for benchmarking performance and striving towards an improved quality of care for patients.
From observational studies to Phase I-IV clinical trials and post-market surveillance, we can assist with all aspects of the planning and setup, governance and management, registration and approvals, as well as the analysis and and reporting. Our multidisciplinary team bring an expansive set of skills that ensure your investigations are well-designed and seamlessly executed.