What’s new: Flex Databases Release 12

May 27, 2021

We constantly update and develop our system to meet clients’ expectations and provide the most advanced and user-friendly system for their needs.  Here’s what’s new in Flex Databases Application Release 12.

Common functionality

  • Mass assignment for Project catalogue: Assigning process becomes faster – just select employees and add them to projects and sites in bulk, no need to do it one by one
  • LDAP-based Single Sign-On: authentication process to access Flex Databases platform using a username and a password provided by their corporate LDAP directory service, no extra passwords for Flex Databases. Available for customers with an on-premises setup
  • SAML-based Single Sign-On for Cloud Customers coming soon

Project Catalogue 

  • Grant access and/or manage permissions for any project role for Clinical Projects
  • Configure module sections: include sections to the menu, configure sections tabs and fields. End-user can configure their own Project Catalogue based on their needs

Learning Management System

  • SCORM: Interactive training and QMS documents can be created using the SCORM format

Pharmacovigilance

  • New workflow: user-friendly, fast, and straightforward, with updated user roles permissions
  • Case import: manually upload XML batches in E2B R3 format to create cases or automatically upload via the gateway
  • Country submissions report: track cases submissions across multiple countries and agencies
  • New report constructor: create line listing easily
  • Tabulations for DSUR and PBRER reports

eTMF

  • TMF Manager: split view for quick document sorting and Just drag and drop files and folders from one panel to another
  • TMF Chat: discuss documents and folders with your teammates
  • Emailing out-of-the System: Share documents with sites and colleagues
  • Export feature: export the documents in the separate module sections, such as:

– My Favorites

– TMF Activities

– TMF Master Copies

– My Views

  • A space to record Reason for items deletion
  • Direct work with MS Word and Excel documents: just double-click the document to open it in MS Word or Excel and seamlessly save it back to eTMF
  • DIA 3.2 Reference Model Support
  • Auto clone placeholder on drag and drop upload: upload batch of placeholders in one click
  • Cross-Projects Dashboards
  • New reports: Processing Time Report and Missing Documents report

Project Management & Budgeting 

  • Cross-project dashboard and reports: quickly analyze any project data you want
  • New processes for change orders/amendments: make any changes to the actual budget with the updated rules and monitor Final project budget
  • Task Card: all task information in one place
  • Advanced connection between PM & Budgeting and Time Sheets:

– Check the hours budgeted for the task during the Time Sheets completion process

– Time Sheet Approver: delegate Time Sheets approval to any user in the system by assigning the additional role in one click

– Review, approve/decline entries, and complete units directly from PM & Budgeting module, no need to go to another module anymore

– Ability to switch off unit name entering within the TS submitting process

  • Updated and upgraded project performance reports
  • Custom invoice template
  • Budget import from MS Excel file
  • Earned Value report new user interface

API

  • Extract any data point from CTMS/PhV and transfer it to any other system
  • Load subjects visit data into Subject Tracking & Invoicing module programmatically

CRA Activity Management

  • Optional Sponsor Approval step for Site Visit Activities – switch on/off sponsor review step in site visit report workflow
  • Global CRA Activity Management Administrator
  • Online editor and ability to add an electronic signature for Confirmation and Follow-up Letters
  • Data filters for trackers: configure filters for data in trackers grids (for all levels of tracker location) and tracker data displayed in printed documents
  • ICF improvements: level-based system for ICF versions creation, from project to site-specific

Subject Tracking & Invoicing 

  • Subject Statuses – more flexible status triggering: now a subject status can be assigned to a subject upon completing a corresponding visit
  • Import Tool: CSV format is available for uploading subjects visits data
  • Import Tool: possibility to upload repeatable or unscheduled subject visits

Sounds like something you’d like to try? Request a demo via the button on top of the page or send us an e-mail to bd@flexdatabases.com to learn more!

More about our product

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.

Learn more
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. 

Learn more
Anything you can do, with DMS would be better – manager & user perspective

Flex Databases DMS is done exactly right – and here’s a quick overview of manager & user processes, that get simply better with its implementation.

Learn more
WSG selected Flex Databases eTMF & CTMS to centralize and optimize study management

WSG selected Flex Databases eTMF & CTMS to centralize and optimize study management.

Learn more

Have we picked your interest?

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.