FT. LEE, N.J. & AUSTIN, Texas - (Business Wire) SAFE-BioPharma Association and the Clinical Data Interchange Standards Consortium (CDISC) have announced they will collaborate to advance the electronic exchange of information across the global biopharmaceutical and healthcare communities. SAFE-BioPharma created and manages the SAFE-BioPharma
™ digital identity and signature standard for the biopharmaceutical and healthcare communities. CDISC has established standards to support the acquisition, exchange, submission and archive of electronic medical research data and metadata. And, specifically related to interoperability between research and healthcare, CDISC has worked with IHE (Integrating the Healthcare Enterprise) to establish the RFD (Retrieve Form for Data Capture) protocol which enables the electronic capture of data required for the clinical trial protocol directly from the patient
’s electronic health record. Both CDISC and SAFE-BioPharma are non-profit organizations.
CDISC and SAFE-BioPharma share the goal of improving healthcare by advancing information system interoperability. CDISC’s mission is to develop and support global, platform-independent data standards that enable interoperability to improve medical research and related areas of healthcare. SAFE-BioPharma’s mission is to be a catalyst in transforming the biopharmaceutical and healthcare communities to a fully electronic business environment by 2012. The research physicians who participate in clinical studies, like all of us, have to fill out forms. And, like all of us, they find filling out forms to be a chore. But new technical advances have helped to streamline the form completion process, and among these advances is the new collaborative work by SAFE and CDISC which allows the physician to electronically sign a form without ever having to ‘put pen to paper.’ The secure and convenient technology will make it easier for physicians and others to complete drug safety and clinical research forms, and will encourage physicians to participate in further studies.
Working with Microsoft, Gemini Security, e-HealthSign, and Integrating the Healthcare Enterprise (IHE), the two organizations are developing a specification to enable the CDISC Operational Data Model (ODM) to accept SAFE-BioPharma digital signatures using the XML Advanced Electronic Signatures (XAdES) standard. The joint team will present this specification to the IHE for review and release to vendors supporting applications using the ODM, including the IHE integration profile Retrieve Form for Data Capture (RFD) SAFE-BioPharma and CDISC also foresee expanding this capability to support multiple HL7 message formats, which encompass a variety of healthcare-related documents, forms, and records.
About SAFE-BioPharma Association
SAFE-BioPharma Association is the non-profit association that created and manages the SAFE-BioPharma™ digital identity and signature standard for the pharmaceutical and healthcare industries. The SAFE-BioPharma industry standard is used to mitigate legal, regulatory and other business risk associated with business-to-business and business-to-regulator electronic transactions. It facilitates interoperability by providing a secure, enforceable, and regulatory-compliant way to verify identities of parties involved in electronic transactions. The Association’s members include Amgen, AstraZeneca, Bristol-Myers Squibb, Genzyme, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Procter & Gamble, Roche and Sanofi-Aventis. In addition to CDISC, SAFE-BioPharma has collaborative agreements with CRIX, HL7, and the eHealth Initiative. For more information, visit www.safe-biopharma.org.
About CDISC
CDISC is a global, open, multidisciplinary, non-profit organization. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website. CDISC has a Charter Agreement with HL7 since 2002 with a commitment to harmonize clinical research and healthcare are standards. CDISC has Liaison A status with ISO TC 215 for Healthcare Standards and is a member of the Joint Initiative Council (HL7, ISO, CEN). Additional information on CDISC can be found on the CDISC website at www.cdisc.org.
SAFE-BioPharma™ is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association.
For SAFE-BioPharma
Jon Weisberg, 801-359-9977
Jon.weisberg@safe-biopharma.org
or
For CDISC
Tanyss Mason, 919-419-7100
tmason@cdisc.org
