Pharma Cyber-Karma

What Every CRO Should Know When Becoming Fully Electronic

Mollie Shields-Uehling
Posted: 11/29/2011

As the global CRO community studies how to most efficiently move to fully electronic business processes, there are numerous issues that must be addressed to assure secure global collaboration. These include identity trust, data integrity, regulatory compliance, and time and cost savings.

Those looking into the options are finding several existing “solutions” as a way for CROs to cover some of the issues. Given the significance of the decision, CRO executives and managers should understand the importance of selecting solutions that are compliant with the global SAFE-BioPharma digital identity and signature standard.


The standard was developed by the major global study-sponsors as a way to meet security and confidentiality needs specific to the life sciences. The US Food and Drug Administration and the European Medicines Agency participated in the process.

Here’s what every CRO needs to know about solutions that are compliant with the SAFE-BioPharma standard:

1. They replace all other forms of electronic identity. One identity is issued to study participants. That identity – tightly linked to the user’s proven identity, as required by the standard -- can be used with sponsors for all studies. This eliminates multiple identities and multiple user name/password combinations. Each participant with a digital identity compliant with the standard agrees to comply with a set of legally-enforceable rules.

2.
They assure the data integrity of any electronic documents, including contracts. This occurs because the user’s identity is linked to the signed document and because integrity of each signed document is cryptographically guaranteed for the life of the document. If the document is altered, it will display an invalidated digital signature. Additionally, it automatically creates a permanent record of the date and time the signature was applied.

3. Secure global collaboration is assured by protecting against unauthorized access or use on either side of the firewall. This feature also protects against hacking and data loss and supports strong evidence in regulatory audits.

4. Solutions compliant with the SAFE-BioPharma standard save time and money by simplifying identity management. They eliminate the redundant costs associated with creating, issuing, and managing new identities for each new sponsor and for each new trial.

5. These solutions also are trusted by US federal agencies and are interoperable with the identity credentials used within those agencies. By way of illustration, both federal and SAFE-BioPharma identity credentials are being used by National Cancer Institute and SAFE-BioPharma member company scientists in cloud-centered research collaborations.

6. SAFE-BioPharma compliant solutions also comply with US and EU regulations. They facilitate 21CFR11 compliance and are preferred for clinical study reports submitted to the US government. They meet EMA digital signature requirements and soon will be required by EMA. Importantly, digital signatures based on the SAFE-BioPharma standard are accepted by the US Drug Enforcement Agency to sign electronic prescriptions for controlled substances.

For CRO decision-makers exploring the best and most efficient way to become fully electronic in their clinical trials, the Verizon announcement gives them 2.3 million reasons to choose a solution compliant with the SAFE-BioPharma standard.

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Mollie Shields-Uehling
Posted: 11/29/2011

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