Patient Reported Outcomes & Registries

Patient reported outcomes (PROs) is a method for measuring aspects of a patient’s health status related to diagnosis or treatment that comes directly from the patient, without the interpretation by a physician (or other allied healthcare provider).

PROs measure aspects of a patient’s health status related to diagnosis or treatment that comes directly from the patient, without the interpretation by a physician (or other allied healthcare provider).

• The FDA is encouraging the use PROs in clinical trials to help tell whether a new drug or medical device is working and how well it is working.
• PBR collects and analyzes PROs for drug and device clients to support product claims and associated NDAs and PMAs.
• PRO instruments offer a structured interview technique that minimizes measurement error and ensures consistency, providing more reliable measurements compared to informal interviews.

Through our technology partnerships we are pleased to offer state-of-art technology platform solutions for conducting ePROs.

Registry Services
Patient registries and other post-marketing studies are often critical to a product’s success. They deal with issues relating to long-term clinical effectiveness, safety, cost-effectiveness, reimbursement strategy, or adoption on the part of HMOs or physicians in the community. PharmaTrak specializes in developing and managing registries sponsored by pharmaceutical, biotechnology, and medical device companies to support REMS and post-market requirements.