SAFE-CRIX Partnership to Enable Fully Electronic Life-Science Transactions

By Daniel R. Matlis

This week, SAFE-BioPharma Association and CRIX International announced a formal collaboration aimed at architecting the CRIX e-platform. The e-platform would handle the exchange of clinical research data (i.e., the data normally collected during the course of a clinical trial), as well as the submission, receipt, and management of regulatory product information. Both SAFE-BioPharma Association and CRIX International are not-for-profits funded by Life-Science companies. 

CRIX International is dedicated to leveraging technology to accelerate and streamline the interaction between sponsors of new drug products, their business partners, research institutions, academia, and health authorities involved in bringing new therapies to patients throughout the world.

CRIX’s North American Advisory Council includes members representing standard organizations including:

  • Clinical Data Interchange Standards Consortium (CDISC), a non-profit organization with a mission to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.
  • Health Level 7(HL7), an international community of healthcare subject matter experts and information scientists collaborating to create standards for the exchange, management and integration of electronic healthcare information. HL7 promotes the use of such standards within and among healthcare organizations to increase the effectiveness and efficiency of healthcare delivery for the benefit of all.

SAFE-BioPharma Association manages the SAFE™ standard, which provides a secure and regulatory compliant way to verify the identities of parties involved in business-to-business and business-to-regulator electronic transactions. The standard also facilitates fully electronic processes by creating a system of trusted identities and legally enforceable digital signatures.

SAFE-BioPharma Association’s members include Amgen, AstraZeneca, Bristol-Myers Squibb, Genzyme, GlaxoSmithKline, Johnson & Johnson, Merck, Organon, Pfizer, Procter & Gamble, Roche and Sanofi-Aventis.

I’m encouraged to see industry organizations, like CRIX, SAFE, CDISC and HL7, coalescing to develop open yet structured approaches to advance the use of information technology in Life-Sciences. These industry standards will yield more efficient processes for the development of healthcare therapies.

I would much rather see our industry developing and implementing consistent standards than government agencies imposing regulatory requirements on Information Technology.

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