A&R Consultants offer the following support services for your Data Development needs
An important step to validate analytical methods. Is your technology and/or laboratory methods both reproducible and reliable?
An independent assessment of your technology/product to confirm the hypothesis generated from product development. Clinical validation can be performed both prospectively and retrospectively. Clinical validation should not be obtained from developmental training sets or cohorts.
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?
What is the “value” add noted from your clinical utility work 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.
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.