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Clinical Trial Management System

CRA Activity Management. Subject Tracking & Invoicing. Investigators & Sites Management.

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Automate your routine CRA tasks with

CRA Activity Management

Create confirmation and follow-up letters in one click with all flexible smart trackers added automatically.

Configure Site Visit Report workflow with electronic signatures to replicate your exact processes.

Poor internet connection at site? Use offline reporting capabilities of the system.

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Track what is going on at sites with

Subject Tracking & Invoicing

Have all the information you need in one place: enrollment, inclusion curve, in and out of time window visits, screen failures and so much more.

Use flexible and exportable widgets, reports, and graphs.

Set, measure, organize, and track site payments.

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Organize all information on investigators and sites with

Investigators & Sites Management

Have sites statuses, documents, contracts, qualification, vendors, timelines and so much more at hand.

Keep all your Medical Institutions and Sites information in a clear organized manner with just a few clicks.

Manage submission packages across countries, studies, and sites in a unified interface.

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What sets Flex Databases apart

Easy implementation

We can deliver a fully functional system in the timeframe from 3 to 10 weeks, depending on the client involvement and requirements

Complete data safety

We have a robust backup & disaster recovery and customer data protection strategy, including distributed data storages around the world

Full compliance

Flex Databases is compliant with all major international and local regulations such as ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.

Flexible solution

Easily configure every part of our proprietary platform. The system is fully managed by end-users. No installation required

Features

CRA Activity Management

Site visit planning and scheduling: Pre-Study, Site Initiation, Interim Monitoring, Monitoring Visits, Close-Out, and any other type

Centralized calendar and personalized calendars of planned visits

Study role-based permissions

Electronic signature

Automated notifications and alerts based on various parameters

Monitoring Visits reports, confirmation & follow-up letters generated automatically on customers templates

Assessment metrics creation and CRA performance assessment

All trackers are completely flexible and configurable – action items, issues, deviations, subjects enrollment and any
her logs

Business Intellig ence reporting – ANY report is possible

Templates designer for all documents – full flexibility with confirmation letters, follow-up letters, site visits reports
d questionnaires

Customizable fields & trackers – all fields in monitoring section can be changed by user at no extra fee

Site visits workflows are flexible and can be configured to reflect customer’s exact process

Offline Site Visit Reports – you no longer depend on internet connection at sites

API for integrations – full integration with TMF, EDC systems

Ad-hoc reporting tool for cross-project and cross-module reporting – graphs, widgets, pies, grids – all exportable

Sponsor step: enable optional sponsor step in the workflow to allow sponsor review and sign reports

Subject Tracking
& Invoicing

Create study and multi-currency site budgets

Invoice based on various triggers: visit, procedures, milestones, etc.

Set up any payment rules with overhead percentage, cost and extra cost reductions

Keep different site budget versions and invoice according to specific version

Copy budget template to speed up trial set-up

Export and report any data on invoicing into sites

Track non-visit related activities (PTC management)

Track unscheduled visits and procedures

Manage open queries resolution

Plan enrollment and compare with the real picture

Plan and schedule patients visits

Track all patient related data

Import data from your EDC system or add subjects manually

Get overall reports on ready to be invoiced, approved and paid activities

Generate invoices & beneficiaries on configurable client-specific or ready- to-use templates

Track invoices status

Void or approve invoices online

Investigators
& Sites Management

Feasibility process

Site team assignment

Site performance

Capturing and tracking of all site communication

Centralized IRB/LEC submissions and approval tracking

Documents tracking (contracts, site regulatory documents, licenses and certificates)

Investigators, sites, hospitals and out-patient clinics, vendor and regulatory authorities information

Reports

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