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Bioclinica Transforms Source Document Management in Clinical Trials

New Solution Combines Advanced Software With Redaction and Translation Services to Support Research Site and Trial Management Teams Around the World

Bioclinica, an integrated solutions provider of clinical life science and technology expertise, launched Source Document Manager. This comprehensive solution enables clinical trial sponsors and contract research organizations (CROs) to collect, de-identify, translate, organize, and manage source documents seamlessly using a secure, cloud-based application. The new product generates notable efficiencies at research sites and eases global trial management in the areas of patient eligibility, routine electronic data capture (EDC), clinical adjudication, and source document verification.

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“The COVID-19 pandemic pushed the industry into decentralized trials and remote trial monitoring, exacerbating challenges with legacy technology and increasing the risk of noncompliance with regulatory requirements,” said Dan Gebow, PhD, Chief Innovation Officer at Bioclinica. “Our solution was designed specifically to simplify the entire process of managing source documents in this environment using a single, centralized location.”

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Bioclinica Source Document Manager supports online protected health information redaction at the site level with verification by a team of quality control experts and boasts direct integration with a premier online translation service to translate source documents. Additional features include:

  • Structured and guided data collection: Mirror specific source document folder structure and designate source documents as required or optional for clear guidance.
  • Multilingual platform: Translate the entire interface into the local language and support multiple languages across a trial.
  • AI-aided redaction: De-identify source documents before upload and ensure every document is both AI-inspected and visually reviewed to ensure completeness.
  • Query management: Get ahead of the delays associated with rectifying low-quality source documents using Bioclinica’s team to query the site for a higher-quality source image and manage the reply for maximum efficiency.
  • Advanced search capabilities: Index, categorize, and tag every item loaded into the solution to allow searches by keywords, phrases, document types, and more.
  • Complete audit trail: Track every click for a complete audit trail of all changes made to source documents during processing.

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Bioclinica Source Document Manager can be used as a standalone data collection and storage module to collect and review source documents online, or it can be integrated with an existing EDC system or other data tracking system to send redacted and quality-controlled source documents to their destination.

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