A Must In Clinical Development Collaborations: Identity Trust

A Must In Clinical Development Collaborations: Identity Trust

Globalism is forcing the bio-pharmaceutical industry to find new ways to work across vast enterprise and geographical boundaries. Companies develop products in cooperation and form coalitions to improve Research & Development. Clinical trials are outsourced to Clinical Research Organizations, often working with researchers and sites across the globe. The computer software products that coordinate and integrate all the activities involved in the management of a health-care facility by the Clinic Management Systems.

With advancement of technologies, cloud computing made it all possible by allowing applications and their frequent updates to be accessed centrally, at a fraction of the expenditure and time required in the past.

But everything has it pros and cons; relying on the cloud exposes organizations to data theft, significant challenges to business security, and regulatory compliance.

So the fact is that identity trust is foundational to clinical development platforms such as TransCelerate's Shared Investigator Platform (SIP) and Merck's EngageZone. It allows all of their participants to collaborate efficiently and securely by convincing that the identity accessing a portal and the valuable information it contains does not belong to someone else. And identity trust soothes the burden on clinical investigators by allowing use of a single identity that can be recognized across business, government and academic attributes.

EngageZone ,SIP and other platforms support collaboration by allowing clinicians, researchers, patient groups, executives, and others participants in drug development to access data and sign and exchange documents. With the potential of thousands of participants from across the globe, identity trust is a must.

The SIP became operational earlier this year, and EngageZone has 60,000+ participants. Each needs those accessing the platforms to use identity credentials that are complaint with the global SAFE-BioPharma.

SAFE-BioPharma is invisible and operates in the background; not unlike lubricant that keep cars performing their best.

Pharma IT executives created SAFE-BioPharma as a way to assure identity trust across the Internet. They chose an approach requiring identity credentials to be issued following a process that proves an individual's legal identity through presentation and review of documentation and/or biometric evidence. The process is connected with national and international laws, regulations and standards. Because of this alliance, identity credentials compliant with the SAFE-BioPharma standard can be trusted by other entities, including pharmaceutical and health-care companies, US Government agencies and companies in other industries.

So this is one credential for many trials. The SAFE-BioPharma identity credential can be used for most other trials from the same and other sponsors. There would be no multiple user names and passwords. SAFE-BioPharma compliant credential will be a single identity. Take it as a personal passport to the Internet; one trusted credential identifying you for all trials.

Individuals with a specific type of SAFE-BioPharma identity credential are able to apply digital signatures to electronic documents. To mention its the single strongest form of electronic signature in existence.

Being based on Cryptography, the signatures are legal binding and can't be defied by the signatory. They provide the strongest proof of the person who gave the signature, and they safeguard the document by unveiling when a change to the signed document is made.

When clinicians, researchers and others participating in collaborative clinical development platforms learn that the identity credentials they've taken are SAFE-BioPharma compliant they'll be able to operate without the hassle of managing too many cyber identities. It would make the entire development process more efficient. And it's all based on identity trust.

The President and CEO of SAFE-BioPharma Association is Mollie Shields-Uehling.

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