How to Ace Your SaaS-based EDC System Validation for Sponsors and CROs
Recorded September 28, 2016
Webinar On Demand
The mounting popularity of Software-as-a-Service (SaaS)-based eClinical technologies has shifted the paradigm of computer system validation in clinical trials. International regulatory authorities, including FDA, acknowledge the need to perform an intended use validation across various industry guidance documents. However, intended use validation is seldom implemented by CROs and Sponsors utilizing eClinical platforms in a SaaS model.
This webinar describes best practices for Sponsors and CROs validating SaaS-based EDC systems, highlighting the importance of intended use validation and a case study example of SDC’s validation of SaaS-based EDC system, iMedNet eClinical.
Watch this webinar to learn:
What auditors want to see in your EDC validation documentation
Understanding intended use validation requirements
Best practices for implementing EDC intended use validation
Key takeaways to ace your EDC validation audit
Quan Doan, Associate Director, EDC Solutions at SDC
SDC delivers top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. We are committed to providing experienced teams who will take ownership of your needs and are positively engaged in your projects. With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/IWRS) expertise at our core, our services are scalable via our diverse and complementary strategic partnerships to provide full service clinical trial solutions. Speak with us today to see why SDC is The Right Fit For You.
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