Clinical and Scientific Research

Our clinical and scientific experience encompasses a broad range of technologies, therapies, medical fields, and indications. We’ve designed and conducted trials to address many varied client objectives- from early-feasibility, first-in-man through post-market phases; Whether the intent is to obtain market approval, improve reimbursement, or generate publications. We offer you knowledgeable support and product-specific expertise with the goal of designing tests and verify product performance according to its intended function and clinical environment.

Our services include (all according to FDA/ MDR or other):

• Developing clinical plan and study/investigation protocol

• Performance evaluation (including clinical usability)

• Writing clinical evaluations (CERs/ IVDR PERs).

• State of the Art - literature searches and bibliographies

• Writing all clinical reports (CSR, annual progress, manuscripts, safety and CAPA, technical papers)

• PMS & PMCF planning and support

• Perform due diligence assessments

• Labeling and advertising material review

• Writing and developing clinical SOPs (we also offer a package of all required SOPs)