Services for Project Sponsors: Outcomes/Observational Studies

Medical Device Company Collects Outcomes Data via Leading Health System

Customer

Medical Device Company

Project Objective

The sponsor lacked clinical evidence to justify the use of its device in light of its competition. Altura was asked to implement an actual use outcomes study with the intent of generating data and producing results that could be analyzed and shared with health systems.

Altura’s Solution

Altura reviewed & assessed the project as designed by the customer and successfully suggested and implemented logistical/operational changes necessary for the conduct of the study in a large integrated health system. Altura managed and supported the health system’s staff to a successful conclusion of the study and collected and compiled data for customer analysis.

Since this need was identified post-approval, this client’s research, marketing and regulatory teams needed the necessary support to drive the project and maintain internal and external compliance. Altura ensured the successful completion of the study.