Bioclinica Adds eTMF Functionality to CTMS

PRINCETON, N.J., Jan. 27, 2021 /PRNewswire/ -- Bioclinica, an integrated solutions provider of clinical life science and technology expertise, today announced the addition of eTMF as part of its CTMS offering. The new module leverages the already linked SharePoint environment to provide a safe, secure storage location for document files related to clinical trials being tracked within Bioclinica CTMS.

“We are thrilled to make this functionality available as part of our CTMS solution,” said Jeremiah Rehm, Senior Product Manager at Bioclinica. “Organizations now have the choice to purchase a single solution or leverage our existing capabilities to integrate with other systems or data sources.”

With this latest addition, users will have direct control over all Bioclinica CTMS, eTMF, and Site Monitoring/Payment functionality. Additional benefits included with the eTMF module:

• Utilizes existing functionality already available within the linked SharePoint document libraries such as version history, workflow logic, alert emails, notifications, and task assignments.
• Supports the DIA reference model.
• Allows uploading and linking of document files to pre-existing document placeholders, which can then be routed through an approval process (if needed) and electronically signed with a 21 CFR Part 11-compliant signature that stamps a physical manifestation of the signature(s) into the documents themselves.
• Ensures regulatory compliance by offering a full audit trail, version history, and activity log for each tracked document file.
• Supports a role-based permission model.

“The addition of eTMF to our CTMS solution is a transformational change for the industry,” said Guy Crossley, President of Bioclinica Software Solutions. “Companies of all sizes are now able to take advantage of an integrated solution that eliminates redundancies, improves workflows, enhances transparency, and enables greater study control. And the system can be fully operational within only a few weeks, which is critical for any successful CTMS implementation.”

About Bioclinica
Bioclinica, an integrated clinical life science solutions provider, leverages knowledge and insight to minimize risk and accelerate development in clinical trials. Through deep medical, scientific, and technology expertise, the company provides medical imaging and cardiac safety services, clinical endpoint adjudication, clinical trial software, and drug safety solutions. Bioclinica’s global team of life science experts serves more than 500 pharmaceutical, biotechnology, and medical device organizations – including top 20 biopharmaceutical companies and leading CROs. For more information, visit www.bioclinica.com.

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SOURCE Bioclinica