First clinical trial that integrates LifeOnKey EHR, PHR with Target eCRF EDC software

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 eCRF^® 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is an observational study in up to 400 subjects that are admitted to various ICU wards and comes on the heels of FDA's draft guidance on "Electronic Source Documentation in Clinical Investigations," and the European Medicines Agency (EMA) "Reflection Paper on Expectations for Electronic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."

The integration of the LifeOnKey EHR with Target eCRF, assures that 1) the clinical research investigator maintains the original source document or a certified copy (Requirement 5, ICH GCP 2.11, 5.15.1); 2) source data can only be modified with the knowledge or approval of the clinical research investigator (Requirement 6, ICH GCP 4.9.3, 4.9.4 and chapter 8), and 3) the pharmaceutical company sponsoring a clinical trial will not have exclusive control of a source document (Requirement 10, ICH GCP 8.3.13).

The LifeOnKey Target Health partnership takes advantage of the extensive expertise in the development of innovative information systems residing in both companies, as well the regulatory affairs and clinical research expertise residing at Target Health. As a result, products can now be moved more rapidly and efficiently to the market.

"We are very confident that our comprehensive solution for the integration of clinical trial software and EHRs for the pharmaceutical industry will be a paradigm shift for the clinical trial space," comments Target Health Inc. President Dr. Jules Mitchel. "With over 18 years of clinical trial and clinical trial information systems developed and implemented at Target Health, coupled with the state-of-the-art Health Management Platform offered by LifeOnKey, this partnership is the first of its kind in the field of Clinical Trials."

"LifeOnKey is joining forces with Target Health to bring to the market the first integrated system to enable clinical research to be part of the revolution in health information systems" explains Dr. Linda Harnevo, CEO of LifeOnKey. "LifeOnKey's vast experience and know-how in health information systems compliments the outstanding expertise of Target Health, providing clients with unique access to "meaningful use" implementation.