Database Development

Sierra | CRO

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Sierra Clinical Services, LLC is a dependable, affordable and dedicated contract research organization (CRO).

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Database Development

Sierra CRO

We build EDC databases that provide data in real time. Our EDC system is a favorite among study sites and includes tools for efficient study management, custom reporting and interactive study dashboards.

At Sierra, our team of experts build EDC databases for any size study from Phase I to Phase IV and everything in between. We utilize efficient and intuitive, Part 11 compliant, validated systems. Custom real-time reporting allows sponsors to access data on-demand via browser or phone. Advanced interactive study management dashboards provide a bird’s-eye view for oversight of study status, site management, safety management and compliance with the ability to quickly drill down to the details.

We generate database design specifications (DDS) based on the study protocol and case report forms or source documents. This serves as the roadmap to the eCRF design and EDC configuration. We partner with you to discuss the details and ensure everything is reviewed and approved prior to database build.

Within the DDS specifications, our experts include detailed electronic data checks that conform to the requirements of the protocol and include checks for eligibility, expected legal ranges, completeness of eCRFs and logical consistency. Prior to programming, the client will review and approve proposed data checks.

Upon completion of the EDC build, user acceptance testing (UAT) will be performed by our experts via a series of test scenarios ensuring the database fully conforms with the DDS specifications. A final UAT report and annotated CRF document are included with the deliverables for every EDC project.

The user training module is customized for each study to include on-demand videos for users to complete prior to obtaining system access.

Our Database Development services include:

  • Database Design Specifications (DDS)
  • Build EDC systems including eCRF design and customized data checks
  • Perform UAT (user acceptance testing)
  • Generate Database Documentation: Go-Live Approval, UAT Report, Annotated CRFs
  • Create eCRF Guidelines
  • User training: On-demand videos and Zoom sessions
  • User support
  • Database modifications as needed

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Whether you have a question about our services, pricing, need a demo, or anything else, our team is ready to answer all your questions.

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