Medical device and IVD companies managing clinical projects need to meet pre-specified project objectives and milestones, which may be challenging.
For example, there may be difficulties in identifying study sites that can guarantee patient enrolment within the desired timeframe. There may be delays with competent authority or ethics committee submission acceptance, or unexpectedly low enrolment in ongoing studies, requiring prompt action to avoid study failure. Perhaps controlling study costs is proving difficult. Even after a study has been concluded, some companies have had their regulatory submissions rejected because of issues with the clinical data.
During an in-company (on-site) clinical gap analysis, our senior clinical experts will meet with your team, analyze the current problems, and propose solutions, using your company’s resources and customized to your company’s needs.
Please contact us for further information or assistance.