The FDA has cleared for marketing a medical cooling device from Lund, Swedenbased 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.
The Society for Clinical Research Sites (SCRS), the trade organization representing over 2,600 global clinical research sites in 42 countries, announces today the finalists for the 2015 SCRS Eagle Award.
Dr. Jules Mitchel shares what it's like being an inspiration to the industry, how he inspires his team and peers, who has inspired him, and the innovations he is seeing in the industry.
PharmaVOICE interview with Dr. Jules Mitchel, the Commander in Chief of Target Health, Inc.
Dignitana AB announced that the company has submitted for review an application to the US Food and Drug Administration (FDA) Center for Devices and Radiologic Health for approval of the DigniCap™ System. Dignitana engaged the Clinical Research Organization (CRO) Target Health Inc., with offices in New York, in 2011, and Dignitana has been working in close collaboration with Target Health to interact with FDA, conduct the pivotal clinical trial and prepare the FDA application.
When original data are captured through validated electronic systems, there is no need to perform source document verification (SDV)> The key to regulatory compliance becomes the availability of validated, independent, contemporaneous copies of source records.