Medical device manufacturers know that regulatory approval can be meaningless without clinical evidence to back their product claims and reimbursement. We offer a broad array of support levels to help companies justify, bolster, and differentiate product claims to clinicians, patients, and payers.
Clinical evidence options are available to manufacturers on a cost continuum. We offer custom support depending on your needs, urgency, and budget. Here are just three options:
- Literature-based meta analysis
- Post-market patient registry study
- Randomized-controlled, multi-center clinical trial
We also provide cost-effective support for FDA condition-of-approval post-market studies. For most companies, it makes little sense to divert internal staff and resources for projects unrelated to future approvals. We can absorb this obligation so your staff can focus on important pre-approval efforts.