SAFE-Biopharma Changes Fees to Help Clinical Investigators, CROs, Others


Ft. Lee, NJ (June 22, 2009)--SAFE-BioPharma Association ( has changed its membership fees to give clinical investigators, CROs and other smaller biopharmaceutical and healthcare entities the ability to affordably sign electronic forms, contracts and other documents digitally. The group made the announcement to coincide with the opening of the annual meeting of the Drug Information Association.

As members of SAFE-BioPharma, investigators, CROs and other small and medium sized entities will benefit from the SAFE-BioPharma standard, including use of SAFE-BioPharma digital certificates to apply signatures digitally to electronic documents. Digital signing -- used for secure paperless transactions -- eliminates the time and hidden costs associated with printing, handling and storing paper documents.

“We changed our membership fees to help the thousands of investigators and others wean themselves from the costs and complications of relying on wet signatures and paper documents,” said Mollie Shields-Uehling, President and CEO, SAFE-BioPharma Association.

SAFE-BioPharma Association is the non-profit industry collaborative that developed and manages the SAFE-BioPharma™ digital identity and signature standard, used by virtually every big biopharmaceutical company for identity management and for digital signing.

SAFE-BioPharma digital certificates are available in a variety of forms, including SAFE-BioPharma’s unique roaming digital ID, which allows documents to be signed with complete security anywhere there is Internet access.

The new fees make a three year SAFE-BioPharma membership available for $50 per year per user with a $250 minimum fee. Obtaining certificates takes as little as a few minutes. Prior to the change, membership fees were oriented to larger organizations.

Among the features of SAFE-BioPharma digital signatures:
…uniquely link the user’s identity to the document being signed
…valid for life of the document; any change to document invalidates signature
…create a permanent record of the date and time the signature was applied
…legally enforceable, non-repudiable, and instantly auditable
…recognized by FDA and EMEA.
…21 CFR Part 11 compliant


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. Because the standard is linked to the Federal Bridge PKI Architecture through the 4BF (www.the, a SAFE-BioPharma digital identity can be trusted by any Federal agency. SAFE-BioPharma’s vision is to be a catalyst in transforming the biopharmaceutical and healthcare communities to a fully electronic business environment by 2012.

The Association’s members include:

* Abbott (NYSE: ABT)
* Amgen (NASDAQ: AMGN)
* AstraZeneca (NYSE: AZN)
* Bristol-Myers Squibb (NYSE:BMY)
* GlaxoSmithKline (NYSE: GSK)
* Johnson & Johnson (NYSE: JNJ)
* Eli Lilly (NYSE: LLY)
* Merck (NYSE:MRK)
* National Notary Association
* Novartis
* Pfizer (NYSE: PFE)
* Premier Inc.
* Procter & Gamble (NYSE: PG)
* Roche
* Sanofi-Aventis (NYSE:SNY).
* ScheringPlough-Organon (NYSE: SGP)

SAFE-BioPharma™ is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from
SAFE-BioPharma Association.

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