Bioclinica unveils new solution for clinical trial management – Clinical Trials Arena

Bioclinica has unveiled the new Source Document Manager solution that combines advanced software with redaction and translation services to offer support to global research site and trial management teams.

Using the new solution, clinical trial sponsors and contract research organisations will be able to collect, de-identify, translate, organise, and manage source documents with the help of a secure, Cloud-based application.

Generating notable efficiencies at research sites, Source Document Manager eases trial management across the globe in patient eligibility, routine electronic data capture, clinical adjudication, and source document verification areas.

Bioclinica chief innovation officer Dan Gebow said: “The Covid-19 pandemic pushed the industry into decentralised trials and remote trial monitoring, exacerbating challenges with legacy technology and increasing the risk of noncompliance with regulatory requirements.

“Our solution was designed specifically to simplify the entire process of managing source documents in this environment using a single, centralised location.”

The company’s latest solution supports online protected health information redaction at the site level, with verification by quality control experts’ team.

It can also translate source documents by integrating with an online translation service directly.

Bioclinica Source Document Manager is capable of designating source documents as required or optional for clear guidance and can translate the entire interface into the local language and support multiple languages across a trial.

Furthermore, by de-identifying source documents prior to upload, it ensures every document is both AI-inspected and visually reviewed to ensure completeness.

The solution also has advanced search capabilities and can track every click for a complete audit trail of complete changes made to source documents at the time of processing.

For the collection and review of source documents online, it can be used as a standalone data collection and storage module.

Additionally, the Source Document Manager can be integrated with an existing EDC system or other data tracking system to transfer redacted and quality-controlled source documents to their destination.