A&R Consultants offer the following support services for your Data Development needs
Analytical Validation
Is your technology and/or laboratory methods both reproducible and reliable?
Clinical Validation
An independent assessment of your technology to confirm the ability to predict a clinical outcome for a specific patient population (Intended Use). Are the test’s results clinically relevant and help solve an unmet need in healthcare?
Clinical Utility
An assessment of your product’s ability to impact patient and physician decision making and does that impact on decision making improve net health outcomes for the patient?
Health Economics
What is the “value” add and how does that impact healthcare spend? It is critical to provide data that your test is cost effective and supports the case for value-based pricing.
Publications
Peer-reviewed publications in respected journals are critical to positive coverage policies and national guidelines.
National Guideline Committees
Publications are not only vital to a reimbursement strategy but also to a guideline strategy. Committees will want these works published in order to consider recommendations for your product. Remember, guideline acceptance will also accelerate your payor coverage.