Flex Databases Application Release 10: What’s new

Oct 30, 2019

HR Database

  • Ability to set up external users access and hide/unhide whole modules for different classes of users.

Investigators and Sites Management System

  • Ability to use free text format in site number.

CRA Activity Management

  • Offline capability: user now can fill in questionnaire offline and then upload it into the System
  • Connection to the Trial Master File: the system automatically uploads documents (Confirmation Letter, Monitoring Report, Follow-up letter, Additional documents) with the correct naming right to the necessary folder in Trial Master File. The system will create a new folder for each visit automatically. Files will be already in Locked status in TMF, so there is no need to go through QC process for the documents twice.
  • Configurable fields and trackers: user can now create any new trackers and fields in the system and add them to the Monitoring Visit workflow step. It’s possible to create several versions of a tracker.
  • Configurable templates: user can now customize the layout of the system generated documents (Confirmation Letter, Monitoring Report, Follow-up letter), to add user-defined trackers, fields, tables and digital signature(s).

Subject Tracking and Invoicing

  • Additional payment rules for Site payments: Complex Subject rule for custom subject payment, Holdback for open query for payment deduction in case of too many open queries, extra payment limitation.
  • Multi-currency: different currencies for budgets and for invoices for different beneficiaries. Users may either use fixed or live updated currency rates.

Trial Master File

  • Configurable QC Workflow: administrators are now able to define new steps of the QC Workflow in addition to the standard set of steps (Review-Approve-Lock). For example, you may add extra approvers to your flow.
  • Automatic upload and filing of documents via e-mail: user may now send files directly to a specified folder in TMF via e-mail. Administrators may restrict only authorized users to use this option.
  • Electronic Signature: user can now use User name/Password combination to confirm his approval/review of the document during the QC process.
  • Archiving: administrator can create an archive of the project documentation or an archive of the selected folders including with Audit Trail and Index report.

Reporting Tool

  • Users can now create any report (pivot, grid), set up rights on position, project or site level, set up graphs and diagrams, create reports, using data across modules or projects.

More about our product

TMF Quality Review 2.0 

Periodic TMF reviews automatically documented. Quality and completeness under control!

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Archiving eTMF for 25 years? Secure, accessible, and compliant with Flex Databases 

Flex Databases offers a solution for all your archiving needs.

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Webinar recording: Digitalizing Quality Management System: How and Why? with Deloitte

Late November we’ve hosted a joint webinar with Deloitte on how you can and why you should consider digitalizing Quality Management System.

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KPI reports – get a complete overview of what’s essential at a glance

What’s usually been a whole collection of different graphs is now in one – and you can see when and if something goes wrong. 

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Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.