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

Larning 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!