CTMS eTMF Blogs
eSign in eTMF provides 80% time savings in document signing Signing documents in clinical research is unnecessarily time-consuming. Printing, signing, scanning and forwarding the documents to the next person is…
Reading time:5
Posted:26 June 2025
Signing documents in clinical research is unnecessarily time-consuming. Printing, signing, scanning and forwarding the documents to the next person is a tedious chore. This process takes at least 5 minutes (if not more) per person who needs to sign.
For an average study with 40 documents and eight signers, this means 320 signature actions. At five minutes per signature, that takes 26 hours of administration time per study. Organizations performing 25 studies per year then spend 667 hours just signing documents. This can also be 80% less if you use the eSign module in our eTMF.
Many eTMF systems offer electronic approval, where users approve documents and the system records this with a time stamp. This functionality meets 21 CFR Part 11 requirements, but this is insufficient when archiving a study.
Clinical trial documents must be kept for 10 years or longer, depending on local laws and regulations. When approval information is only in the system with a time stamp, and not in the document itself, this information is lost when the system is no longer accessible. Therefore, regulatory agencies still want a wet or qualified electronic signature in documents. This creates an inefficient situation where teams still have to download documents from the eTMF system, manually sign them and upload them again.
ResearchManager solved this challenge by integrating validated eSign functionality into the eTMF system. The solution combines the existing digital workflow with the compliance requirements of putting a qualified electronic signature in study documents.
Users can sign documents directly in the eTMF without having to download and print them. Signed documents are automatically uploaded with a certificate confirming validity. When a study is archived, all signatures are visible in the PDF file.
A clinical trial manager selects the documents to be signed and chooses which officers to sign it and in what order. For example, first the principal investigator, then the data manager, then legal and last the sponsor.
With one click, the eTMF system sends emails to all involved according to the set order. Each recipient receives a link directly to the document and the ability to add a digital signature in the system itself.
Does it escape the attention of some signatories? Then the eTMF automatically sends reminders to people who have not yet signed. After all officials sign, the final document is automatically archived with all signatures visible in the PDF file.
The time savings of validated eSign are significant. Take an organization that conducts 50 studies per year. Each study requires an average of 40 documents to be signed by 8 different officials.
Traditional print-draw-scan method:
With eSign functionality:
Time savings exceed 1,000 hours per year.
For an average teaching hospital or (large) CRO, this means a cost savings of tens of thousands of euros per year in staff hours alone.
The eSign functionality requires a one-time integration plus annual licensing fees. For organizations with many studies and large research teams, the return on investment is quick. For smaller organizations with only a few studies a year and small teams, the traditional method can be even more cost-effective. The break-even point is around 10 studies per year with an average of 20 documents and 5 signers per document.
Our validated eSign functionality complies with all relevant clinical research laws and regulations. Key features include:
ResearchManager deliberately chose to partner with ValidSign to implement eSign functionality in the eTMF. ValidSign is a specialized provider of digital signature technology that meets all international compliance standards.
For our customers, this has significant benefits. They gain access to enterprise-grade signature technology without having to purchase ValidSign licenses themselves. ResearchManager manages the licenses centrally, keeping costs lower than if organizations purchased ValidSign individually.
Moreover, this integration into the eTMF system means that users continue to work within one familiar environment. You have no external systems, no separate logins, no manual uploading and downloading of documents between different platforms. It’s built into the workflow in the eTMF.
With eSign in the eTMF, ResearchManager eliminates the time-consuming process of printing, manually signing and scanning research documents. The validated eSign functionality allows clinical trial managers to start a workflow with one click where documents are digitally signed according to preset order. This results in 80% time savings per signature: you go from (at least) 5 minutes to 1 minute.
For organizations with 10+ studies per year, this provides thousands of dollars in cost savings, while maintaining full compliance. Unlike standalone tools such as DocuSign, eSign is fully integrated into the eTMF system, keeping users working within one familiar environment.
Want to learn more about using eSign in our eTMF? Our consultants are happy to think through the possibilities with you.
