Electronic TRIAL MASTER FILETAILORED FOR YOU. MANAGE HIGH VOLUME OF DOCUMENTS Online file sharing & versioning Automatic capture of Metadata Quality Control. - презентация

1 electronic TRIAL MASTER FILETAILORED FOR YOU

2 MANAGE HIGH VOLUME OF DOCUMENTS Online file sharing & versioning Automatic capture of Metadata Quality Control using machine learning Publication to DIA Reference Model Cloud based platform and data storage

3 CREATE ONE STORAGE SOLUTION FOR ALL DOCUMENTS Easy collaboration on a single platform of all clinical trial team including PMs, CRAs and PIs accelerates the processes ClinDisc eTMF advanced access control allows you to create tailored workspaces for each team

4 USE ONE VALIDATED PLATFORM TO IMPROVE DATA SECURITY Clinical Trial documents should not be sent as attachments - is not secure and unreliable ClinDisc eTMF facilitates secure data exchange using end-trend data encryption and confirmation of delivery

5 LET THE SYSTEM HELP YOU TO IMPROVE INSPECTION READINESS Plan, implement and monitor execution on various stages of clinical trial by setting up missing documents alerts Dashboard with real-time metrics makes it easy to review the quality of the eTMF

6 Place your screenshot here INTUITIVE INTERFACE Our interface is built on the simple usability principles so minimum training required to start using the system

7 Place your screenshot here DOCUMENT TEMPLATES With ClinDisc eTMF it becomes really easy to create eDocuments and simply complete them online

8 Place your screenshot here DRAG & DROP MULTIPLE FILES ClinDisc eTMF allows you to upload multiple files and be sure that validation of each file is performed

9 Place your screenshot here PLAN AND CONTROL PUBLICATION OF FILES TO DIA RM eTMF completeness can be easily managed by scheduling of publication deadlines and automatic alerts will be sent to the responsible persons

10 Place your screenshot here MANAGE PERMISSIONS FOR FILES AND FOLDERS Files and folders inherit access rights from its parent folder which can be modified at any hierarchy level

11 Place your screenshot here DOCUMENT LEVELS Documents are assigned different levels and can be filtered based on the level to easily find the right documents

12 Place your screenshot here AUDIT TRAIL User independent audit trail captures all the details of user activity and is readily accessible through the interface for review at any moment

13 QUALITY CONTROL support for risk-based Quality Review of the documents e-signature of the reviewer is captured during the review process automatically generated audit logs and reports of the review process review completeness indication Using the ClinDisc eTMF you can control the Quality of the uploaded documents on multiple levels

14 ACCESS RIGHTS ClinDisc eTMF restricts user access rights in four ways: by study (controls access to the whole study) by organisation (controls access to the certain folder/file) by group (controls access to the certain action) by user type (controls access to the system views) Simple yet flexible access control rules make it easy to manage permissions and files visibility