Life Sciences

Can Clinical Trial Software Be Validated In The Cloud?

clinical-trial-software-validation-cloud

 

We recently discussed customizing and configuring clinical trial software that is hosted in the cloud. For the final post in our “cloud fact or fiction” blog series, we’ll discuss the hot topic of validation. 

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Claim #10: Hosted clinical and safety systems cannot be validated.

Fact or fiction? Fiction.

Hosting a clinical trial, data or safety system in a private cloud does not hinder the ability to validate or maintain a validated state.

However, there are some additional considerations for hosted systems and additional steps organizations should take to ensure the integrity, security, safety, accessibility, and compliance of hosted applications and data. For specific guidance on this topic, please contact us to discuss.

We hope you’ve enjoyed the 10 posts in this series about cloud hosting for clinical trial software, and have found them both fun and informative. If you have any questions about the content in these posts or about cloud hosting in general, we’d love to hear from you.

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Sally Miranker

As the Head of Validation in Perficient’s life sciences practice, Sally Miranker is responsible for overseeing the Computer System Validation (CSV) methodology, System Development Life Cycle (SDLC), and all project-related validation activities. She has over 20 years of experience in the industry with almost a decade focused on implementing computer systems within regulated environments. Her knowledge and experience contribute to her ability to ensure that Perficient’s internal and client systems are implemented effectively, in compliance with internal procedures and external regulations, and following best industry practices. Prior to joining the company in 2009 via the acquisition of BioPharm Systems, Sally held a Siebel Systems Analyst position at Amylin Pharmaceuticals.

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