Source Document Manager

Simplify the submission and management of source documents for clinical trials.

Bioclinica Source Document Manager (SDM) allows you to digitally transform how you manage and organize source documents for clinical trials. Our secure, web-based application can collect, de-identify, translate, and organize your source documents in a centralized location so you can access your documents anywhere in the world.

Benefits of Source Document Manager

Easy to Use
Rapidly submit data from anywhere with ease using our secure Global Cloud Network. Available in any language, the highly intuitive interface simplifies access and uploads for sites around the world.
Achieve 21 CFR Part 11 and EU GDPR Compliance
Our AI-based Protected Health Information (PHI) detector guides redaction to adhere to patient privacy regulations, and every page is reviewed by our redaction quality control (QC) team before the source document is made available.
Minimize Workload
Combine leading-edge software with redaction and translation services to minimize the workload for the research site and trial management team.
Save Time
Eliminate time spent navigating lengthy PDFs containing multiple source documents. SDM allows you to organize uploaded documents into separate folders to streamline processing and querying.

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Customer Support You Can Count On

Address questions quickly with access to live support 24/7/365 via chat, phone, or email within the platform. Our data QC technicians, data managers, and security teams are dedicated to making your Source Document Manager work for you.

Features and Functions

Bioclinica Source Document Manager is a comprehensive solution for collecting, processing, translating, and reviewing source documents. Our flexible, modular solution enables PDFs and other allowed file formats to be uploaded into a well-defined folder structure. The system also supports online PHI redaction at the site level, as well as language translation, redaction verification by a team of experts, and query management.

  • Structured and guided data collection: The flexible platform mirrors your specific source document (SD) folder structure. SDs can be required or optional depending on your needs. You can even incorporate guidance that helps users determine which SDs should be collected and whether they are required.
  • Multilingual platform: The entire interface can be translated into the local language and can support multiple languages across your trial.
  • Language translation: Transperfect translates source documents through direct integration to meet your desired turnaround time.
  • Complete audit trial: Unlike standard PDF redaction and offline review, SDM tracks every click so you have a complete audit trail of all changes made to the SD during processing.
  • User permissions: Is more than one user at the site submitting data? SDM can be configured to let multiple users submit SDs simultaneously or can tighten controls so certain users can only submit specific SDs.
  • Query management: If a low-quality source image is uploaded, our team queries the site and manages the reply for maximum efficiency.
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Simplify the Management of Source Documents for Your Clinical Trial

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Easily store and share 21 CFR Part 11 and GDPR compliant images anywhere in the world from any device for use in future clinical trial projects or audits for up to 25 years.