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Verified Clinical Trials (VCT) Will Co-Present With SAFE-BioPharma At Bio-IT World April 10th In Boston, MA Exploring Identity Management In eClinical Trials
Date:4/10/2013

ssion will feature several proof of concepts including the use of tablets to collect patient data in hospital blackout zones, digitally signing ePrescriptions, and managing access to clinical portals. The POCs are designed to decrease study start up time, reduce cost to start up and operation of trial, ensure the security and privacy of subject information and improve safety and data quality.

VCT will issue digital identities based on the SAFE-BioPharma standard for all clinical research site personnel. These personnel may use their SAFE credentials for authentication and signing of documents including signing of 1572, budgets, contract, delegation logs, e-consents, amendments, study protocol signature pages, training modules, and other study related documents. This will result in reduced paperwork, decreased study start up times, decreased cost and assurance of a verified identity.

Clinical trial volunteers will also be verified and obtain SAFE-BioPharma digital identities to ensure true identity. Research subject participants across all studies will be able to issued by a VCT a proxy de-identified digital identity to sign e-consents, e-diaries, and study related information. The research subject participants will be verified to prevent attempted dual enrollment in clinical trials to ensure better quality research subjects enter the trials.

The technologies will also be used to create a map of disease entities by geography and create a research subject self-managed ‘opt-in’ method for pharmaceutical companies to anonymously reach out to subjects directly for study safety updates and for recruitment purposes. In an effort to improve safety, pharmaceutical companies will have the ability to directly reach out to the consenting research subjects that will remain de-identified and anonymous. In this manner, important information regarding the study compound
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