Medical Device Sponsor Receives FDA Approval Using Target Health's Services

Lund, Sweden-based Dignitana, a manufacturer of medical cooling devices, engaged CRO Target Health in 2011 toward its approval of DigniCap® System, its product to protect cells and hair for patients in chemotherapy treatment. 

Dignitana engaged Target Health to interact with the FDA, prepare and submit the Investigational Device Exemption (IDE) and FDA application, as well as manage the clinical trial, performing data management, running the statistical analyses and writing the study report. Target Health used eSource technology to support the marketing request. The pivotal clinical study was conducted at five clinical sites; University of California San Francisco, Wake Forest Baptist Medical Center, Weill Cornell Medical College, Beth Israel Medical Center, and UCLA Hematology Oncology Santa Monica. The first patient was enrolled in August 2013 and the last patient was enrolled in October 2014. A total of 101 evaluable patients were included in the treatment group and 16 patients were enrolled in the control group.

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