Our BD&Marketing Director Evgenia Michalčuk-Vráblík has recently set down with LifeScience Review reporter to talk about the No-Code approach that Flex Databases is leading in CTMS world and how it benefits our client’s business operations.
Speed up your clinical trials, increase the quality of the operations, and meet all the regulatory requirements. By leveraging Flex Databases, you can optimize your clinical operations, enhance data management, streamline processes, ensure compliance, and improve collaboration among study stakeholders.
From setup to seamless management
- Centralized Management of Clinical Data: having a centralized platform for collecting, storing, and retrieving data. This eliminates the need for multiple systems and manual data entry, ensuring data integrity throughout the trial lifecycle.
- Streamlined Study Setup: simplifying study setup with customizable templates and workflows. Users can easily configure study structure, data entry forms, and visit schedules, saving time and facilitating faster study start-up.
- Efficient Monitoring and Site Management: getting tools for real-time tracking of site activities, including subject enrollment, visit completion, and adverse events. It supports remote monitoring and enhances communication and collaboration between sponsors, CROs, and sites.
Reporting & Compliance
- Reporting and Analytics: generating automated reports such as site visit reports, subject status reports, and safety reports. Real-time data visualization and analysis tools enable stakeholders to gain valuable insights and make data-driven decisions.
- Regulatory Compliance: following regulatory compliance following industry-standard guidelines and Good Clinical Practice (GCP) regulations. It includes features like audit trails, electronic signatures, and data validation checks.
- Collaboration and Communication: providing a secure platform for document sharing, messaging, and task management, improving collaboration between study stakeholders. Real-time communication accelerates study timelines.
- Multi level- and role-based access permissions setup
- Automated notifications and alerts based on various parameters
- Business Intelligence reporting – ANY report is possible
- Customizable fields & trackers
- All trackers are completely flexible and configurable – action items, issues, deviations, subjects enrollment and any other logs
- Template designer for all documents – full flexibility with confirmation letters, follow-up letters, site visits reports and questionnaires
- Single sign-on functionality is available using LDAP and SAML protocols
- API is available for use in bidirectional integrations
- Online & offline access to monitoring reports to keep data completeness at 100%
- API for integrations – full integration with TMF, EDC systems
- Sponsor step: enable optional sponsor step in the workflow to allow sponsor review and sign reports
- Multi-currency study & site budgets
- Various triggers for invoicing: visit, procedures, milestones, etc.
- Site Feasibility process
- Centralized IRB/LEC submissions and approval tracking
- Documents tracking (contracts, site regulatory documents, licenses and certificates)
- Any payment rules are available: with overhead percentage, cost and extra cost reductions
- Enrolment planning & reporting
eTMF & DMS essentials
- Automated filing of documents from CTMS
- Email upload – send email with attachment directly to eTMF & DMS
- TMF & DMS are connected as an external drive through WebDAV protocol
- My Views section – user-defined lists of documents based on metadata groups
- QC Workflow for all file types, folders and placeholders
- Real-time statistics on folders completeness
- Powerful search engine by various parameters in name and file content
- Custom metadata setup and management
- Metadata-based actions (e.g. notification on expiry date of the document)
What sets Flex Databases apart
We can deliver a fully functional system in the timeframe from 3 to 10 weeks, depending on the сlient 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.
Flex Databases is compliant with all major international and local regulations such as: ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.
Easily configure every part of our proprietary platform. The system is fully managed by end users. No installation required.
What they say about us
Our expertise areas
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.