Health Level Seven (HL7), one of the world’s most prolific healthcare standards developers, recently joined the OASIS eTMF Standard Technical Committee, a growing group of BioPharma stakeholders working together in a collaborative effort to develop a standard for clinical trial electronic master file (eTMF) data exchange.
The new eTMF Standard, developed under the global standards information technology organization OASIS, will coordinate inputs from organizations such as CareLex, CDISC, and the DIA TMF Reference model community, software vendors and clinical research organizations. Widespread interoperability of clinical trial content will provide unprecedented levels of collaboration between clinical trial stakeholders resulting in expedited delivery of new drug therapies to patients worldwide. As a result of the standards-based framework for eTMF data exchange, sponsors, CRO’s, Investigators, research organizations and consultants will be able to share data securely through the cloud. Additionally, standards-based formats for clinical trial content exchange will enable automation of clinical trial processes that will save time and money for everyone involved. As a founding sponsor of the OASIS eTMF Standard, SureClinical welcomes HL7 to our initiative.
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