NEW YORK--(BUSINESS WIRE)--Target Health Inc., and LifeOnKey Inc., are pleased to announce the initiation of the first clinical trial that integrates the LifeOnKey electronic health record (EHR) and Personal Health Record (PHR), with Target e*CRF® electronic data capture (EDC) software. The clinical trial is an observational study in up to 400 subjects that are admitted to various ICU wards and comes on the heels of FDA’s draft guidance on “Electronic Source Documentation in Clinical Investigations,” and the European Medicines Agency (EMA) “Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials.”
