ClinDisc eTMF is more than just an electronic storage of documents associated with a clinical trial – it facilitates group work of geographically dispersed teams, making it possible for clinical study team members to organise collaborative work on documents in an easy and efficient way, much like simple online file sharing. But it is not where it ends – ClinDisc eTMF comes with predefined standard DIA TMF Reference Model and allows documents to be quickly organized in a manner suitable for evaluation by inspectors and make them available for inspection online. Also the system features automatic & manual Quality Control of documents, version control and really flexible system of access control with allows its use by sponsors & CROs simultaneously.
ClinDisc eTMF system is designed to simplify storage and sharing of documents & artifacts associated with a clinical study and allows you to:
- Easily share study documents with clinical study team members both internally and externally.
- Prepare study documents for inspection within one system without copying or duplicating data.
- Perform automated and manual Quality Control of the documents.
- Publish documents into DIA TMF Reference Model structure with just a click on a button.
- Advanced support for cloud storage of documents to ensure durability, availability and high performance on large volumes of data without compromising security.
- Pluggable authentication modules allows seamless integration with existing corporate systems.
- Support for DIA TMF RM extensions, study milestones & standard metadata import/export.