- Puławska 38, 05-500 Piaseczno
- +48 792 850 530
- contact@neo-vinci.com
The eTMF Document Management Module is a key tool that supports the organization, storage, and tracking of documents related to clinical trials. It enables digital archiving of files, version control, and access management, ensuring efficient and regulatory-compliant documentation handling. To streamline the flow of trial documentation, the system provides a dedicated module for document management. All files are categorized, and access to specific categories can be granted to designated users or research sites. Once uploaded, each file can be downloaded directly to a local computer.
NEO-CRF offers the capability to implement both eTMF and eISF for investigative sites. The document management module within the eCRF plays a crucial role in clinical trials by ensuring organization, regulatory compliance, and data security. Proper document organization is not only a convenience but also a regulatory requirement under guidelines such as GCP, FDA 21 CFR Part 11, and EMA.
Ensuring regulatory compliance – incomplete documentation may cause trial delays or even lead to its invalidation.
Minimizing risk of errors – automatic version control, auditing, and user permissions prevent accidental loss or modification of critical files.
Facilitating team collaboration – a centralized repository enables quick access to up-to-date documents for investigators, monitors, and sponsors.
Protection of sensitive data – advanced security measures and access controls ensure that confidential information remains secure.
● Simple status handling of submitted documents for administrative and site roles,
● Separation of the module into eTMF and eISF components,
● Support for any file format,
● Ability to assign document versions,
●Unlimited number of categories.
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