eTMF/eISF

As a part of full-service clinical trials support Smooth Drug Development provides comprehensive electronic Trial Master File (eTMF) and electronic Investigator's Site Files (eISF) services. We provide the capability for a complete remote approach to trial conduct, including document collection and management thank to its eTMF/eISF module.

Electronic ISF is integrated into electronic TMF. Thus, both general study documents as well as sites documents are stored electronically which helps to be inspection ready 24/7.

Smooth Drug Development can launch an eTMF and eISF using Smooth CTMS eTMF module and capture the full eTMF/eISF audit trail throughout the trial.

We provide the following services as a part of eTMF/eISF services:

• eTMF/eISF Plan and module training
• eTMF/eISF set up
• Index configuration and agreement with Sponsor
• Automatic naming of documents
• User management (sites, Sponsor, CRO)
• Documents upload and processing
• Paper documents processing and scanning
• Documents maintenance
• Quality control and oversight
• Completeness assessment
• Real time eTMF completeness status
• Inspection readiness provision
• Alerts about missing or expired documents
• Remote review of documents by CRAs/CTAs
• Final eTMF/eISF export for Sponsor and sites

Using Smooth Drug Development eTMF/eISF module provides a myriad of advantages for all parties.

Smooth Drug Development wins because we no longer need to set up and print millions of copies of documents for regulatory binders, so start up is faster and more efficient. We do not need to send our CRAs to clinical research sites to review clinical study documents. The ability to conduct remote site monitoring, recommended by the FDA and EMA, helps our clinical research associates work more efficiently. We can now identify missing documents more easily than by reviewing paper regulatory binders. Our Quality Management wins because we can conduct audits remotely in a fraction of the time without travel, from anywhere in the world.

Our Sponsors win because they have full visibility into eTMF and each site’s eISF documents-assuring they are always audit ready. Sponsors also win because the eTMF and eISF are completely aligned.

Sites win because they save hours of time (e.g., printing documents for PI signature, copying documents multiple times), space in their facility, and long-term storage costs of documents after the study.

Additional benefits include:

• All documents in one place, easy to access documents
• No paper regulatory binders
• Monitoring visits are easier
• Sites are more inspection ready

Smooth Drug Development eTMF/eISF module allows us to provide consistent quality, completeness, timeliness, and oversight necessary to achieve and maintain regulatory compliance.