Product Using Direct Data Entry Receives FDA Marketing Clearance

The FDA has cleared for marketing a medical cooling device from Lund, Sweden-based Dignitana. Digitana engaged Target Health as its CRO, using its web-based eSource-enable EDC system to collect direct data entry from patients. According to Target Health, this is the first product to be approved using in its pivotal trial, direct data entry of patient data at the time of the clinic visit into an EDC system, with no need for paper records.

Target Health and three major medical centers were inspected with no FDA findings related to Target Health’s approach to the paperless clinical trial. Digitana originally submitted for approval in March 2015.

Target Health is also reporting that an NDA with seven studies using the same paperless approach was submitted November 25 to the FDA, with other international submissions planned. Additionally, two pivotal trials in neurology are underway, as well as a study integrating EDC with the electronic medical record, which will begin in Q2 2016.