Clinical Trial Document Management
- Audit ready
- Powerful search engine
- Fit for global usage
- Full EDMS integrated
Ennov’s Intuitive eTMF
Clinical Trials are the most expensive, strategically important and critical step in the pharmaceutical product life cycle.
Clinical operations face big challenges, including lack of uniformity due to multiple documents contributors, as well as the need to track and control data to ensure compliance with regulatory standards.
With the Ennov eTMF manage your eTMF and visually follow up studies and documents for audits and submissions.
Benefits of eTMF
- Real-time overview of clinical study progress
- Efficiency: distant 24×7 access to documents
- Pre-configured with data standards based on the DIA eTMF reference model
- Compliant with FDA recommendations for trial audits
Clinical Study Content Management
Ennov has developed the most intuitive and mobile electronic Trial Master File solution for Life Science companies.
Streamline the whole document life cycle of your clinical documentation by centralizing your data, and fostering collaborative work to help create, co-author, proofread, sign, distribute and archive all versions of your documents.
Build, share and store your Trial Master File in a unique and robust platform with Ennov Electronic Trial Master File (eTMF) to ensure companies can deploy complete regulatory content management systems without requiring extensive IT resources.
Have Control of Your Progress
Essential documents are critical for audits. Follow up with your eTMF by making sure you have all the necessary documents you need. Define checklists of expected documents and their deadlines.
Using Ennov eTMF progress report, check which documents you have, which you need to create, or what you need to continue working on with your collaborators before your eTMF is complete. Sponsors and investigators can also use this to maintain record of document locations.
Evaluate both the conduct of a clinical trial and the quality of the data produced. Streamline your clinical documentation and be audit-ready.
Sponsors, CROs and investigators can easily monitor all their clinical document processes in compliance with the regulatory agencies requirements.
Following the DIA TMF Reference Model, Ennov eTMF embeds a unique document repository using data standard to conform and better organize your document lifecycle.
- Full web access perfect for remote auditing
- Powerful web-based electronic trial master file software
- Fast access to documents with powerful search engine
- Comprehensive overview of the clinical study progress in real time
- High Security: access rights and confidentiality levels
- Easy sort with configurable views, queries, statistics
- Conforms documents (through template/file type management)
- Lifecycle management: status of documents
- Scanner Connector
- eTMF document alerts
- Metadata and full text search
- Lists of documents required
- Fully-integrated with our EDMS and Ennov platform
- Available from any platform (i.e. computer and mobile device)
- 21 CFR part 11 compliant
Cloud-based or On Site
eTMF – one of our Clinical Solutions
Why Choose Ennov ?
Hundreds of corporate customers trust Ennov
- 15 Years of experience in Clinical
- 150+ life science customers, many more in other industries
- Modern architecture and interface
- Application server for scalability
- You matter to us
- 98.5% of projects delivered on time and within budgets
- High and improving customer satisfaction
- Use of human resources: time spent on various steps
- Compare activities over similar products / period of time
We respect your freedom of choice
- Available as cloud or on premise.
- You can switch between options at any time.
- We make you autonomous
- Configuration requires no IT skills
- Improved security and optimized performance.
- Data is hosted locally for total flexibility
- Full range of pre-integrated clinical study tools.
- Based on our high end EDMS/BPMS platform.
To book a demo, the best way is to fill the following form. You will be contacted very quickly by our team.
Send us a mail at: email@example.com.
Contact our European office.
San Jose, USA
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San Jose, CA 95113
+1 (833) 366-6887
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251 rue du Faubourg Saint Martin
75010 Paris – France
+33 (0) 220.127.116.11.38
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+1 (919) 924 5004
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Chuo-ku, Tokyo 104-0045, Japon