Product Overview
Gain Control of Your Clinical Documentation with Ennov eTMF. The eTMF is an electronic trial master file solution to collect and manage essential trial documents in a centralized repository and makes them available to clinical teams, via the internet, from any location at any time. The benefits of using Ennov eTMF include streamlined processes, increased transparency, simplified tracking and enhanced security.
Our eTMF leverages the power of our comprehensive Enterprise Document Management software and Business Process Management software, as they serve as the foundation of the solution. The robust metadata driven document model, highly configurable workflows, powerful searching and flexible views combined with our engaging and intuitive user interface provide all the functionality required to effectively and efficiently manage your clinical trial documentation. Ennov eTMF’s scalability and security enables you to safely manage large volumes of documents – making it the perfect solution for global deployments. Ennov TMF dashboards help organizations to decrease risk, increase efficiency, and improve quality.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
The Trial Master File Challenge
Management of essential trial documentation is, indisputably, one of the most time consuming and costly activities associated with conducting a clinical trial. ICH E6 guidance on Good Clinical Practice (GCP) specifies an inventory of over 200 discrete documents that must be managed before, during and after the trial.
Any or all of these documents must be available for audit by the sponsor and for inspection by the regulatory authorities, and considering the massive volumes of documentation involved in the process, the effective management and exchange of study documentation can have a significant impact on the cost and time to complete a clinical trial.
Yet despite the costs in time, effort and money, the trial master file (TMF) is often still managed through a combination of paper and simple shared folders, scattered across many locations in various countries.
Standards-based but Highly Flexible eTMF Software
The eTMF is a comprehensive solution for managing clinical trial documentation. The document inventory is pre-configured in alignment with the DIA TMF Reference Model and includes all required zones, sections and artifacts.
Ennov eTMF’s metadata-based document model provides the flexibility to adapt this model to your company’s organizational needs. Our intuitive suite of design utilities allow administrators to configure and manage the system without needing IT skills.
Ennov eTMF’s scalability and security enables you to safely manage large volumes of documents – making it the perfect solution for global deployments.
About the company
Headquartered in Paris, with offices in the US, UK, and Asia, Ennov provides the most original, comprehensive and cost-effective suite of software solutions for the Life Sciences industry. From leading pharmaceutical companies to emerging biotechs, we proudly serve over 250 companies and 250,000 users around the world.
For more than 20 years, we have been developing innovative, powerful and easy-to-use software for regulated content, data and process management. Our solutions are designed and built to support the entire Life Sciences R&D continuum including Clinical, Regulatory, Quality, Pharmacovigilance and Commercial. Ennov is ISO9001:2015 certified for all software products and processes and we boast a 100% success rate in customer audits.
Our solutions enjoy extremely high user adoption rates, thanks to our intuitive user interfaces and commitment to building solutions that work the way our users work. We also have very high customer satisfaction ratings with an on-time project delivery rate of 98.5% and an annual maintenance renewal rate of 96%.