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is an observational study in up to 400 subjects that are admitted to various ICU wards and comes on the heels of FDA's draft guidance on "Electronic Source Documentation in Clinical Investigations," and the European Medicines Agency (EMA) "Reflection Paper on Expectations for Electronic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."
"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"
The integration of the LifeOnKey EHR with Target e*CRF, 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.
About Target Health, Inc.
Target Health, (www.targethealth.com) established in 1993, is a full service eCRO with full-time staff dedicated to all aspects of drug and device development. Areas of expertise include Regulatory Affairs, strategic planning, IND, IDE, eCTD NDA, PMA and 510(k) submissions, Clinical Trial Monitoring and Project Management, Biostatistics, Data Management, EDC utilizing Target e*CRF® and Medical Writing. Target Health has also developed a full suite of eClinical Trial software including Target e*CRF® (EDC plus randomization and batch edit checks); Target e*CTMSTM; Target Document®; (paperless TMF and beyond); Target Encoder® (for MedDRA and WHO Drug); and Target Newsletter®.
About LifeOnKey, Inc.
LifeOnKey (www.lifeonkey.com) is an innovative provider of a health platform and solutions for connected healthcare. It develops and markets the eHealthStudioTM a proven syndication platform for patient-centric business processes and health applications. These medico-business processes and Apps perform independently, or can be integrated into legacy systems to generate innovative applications across the health landscape and leverage its information assets, driving improvements in the quality, and efficiency of patient care. Among other properties, the Studio facilitates the aggregation, dissemination and sharing of medical data between physicians, consumers, patients, hospitals, labs, pharmacies, payers, Pharma companies, marketers, and researchers - data to be used within each of the Apps. Applications meet the meaningful use standards. LOK currently has contracts worldwide as well as more than 1.7 million registered members in its network.
LifeOnKey's headquarters are located in New York, USA, and its R&D in Herzlya, Israel.