Flex Databases compliance checklist for EMA Guideline on computerised systems and electronic data in clinical trials
Manage all your clinical trial processes in real time with a single platform
Manage all your CRA activities, patients’ data, sites, and invoicing in real time
- Schedule monitor visits, assess CRA performance, and generate any type of visit reports.
- Set up online invoicing, payment rules, and different site budgets.
- Organize all the information on investigators, sites, vendors, therapeutic areas in one place.
Gain complete visibility into all of your trial documentation
- Get instant safe access to your trial documentation from any place in the world.
- Ensure constant audit readiness of your TMF.
- Upload documents in seconds, see missing files, review, and correct everything in real time.
Make the complex financial part of your project easy
- Plan and allocate resources and workload for an unlimited number of projects.
- Track and analyze project performance with automated reporting.
- Manage all project-related expenses in one place.
Ensure robust and compliant pharmacovigilance activities throughout all the trial stages
- Manage all PV processes within one system.
- Communicate with partners and regulatory authorities directly via EDI gateways.
- Make reports in any format, required by regulatory authorities.
Manage all quality-related activities and personnel qualification level
- Manage SOPs, audits, incidents, CAPA, and all the quality-related activities.
- Organize easy onboarding of new employees with automatically assigned training.
- Get a complete view of your employees’ knowledge level with advanced reporting.
Ensure fast capturing and reviewing data of your clinical studies in a user-friendly interface
- Have a complete track of your study in one system
- Arrange fast and easy completion and check of your eCRFs
- Save money with complimentary IWRS and 4 randomization types in accordance with your study design
What they say about us
John Douglas Snowden
Senior Vice President of Technology Innovation at NCGS, Inc.
NCGS has partnered with Flex to utilize nearly the entire suite of cloud-based modules Flex has to offer for the industry. NCGS believes in Flex’s vision for their platform as it so closely ties to our own ideals of uniformity and simplicity in operations and the delivery of true quality.
Chief Innovation Officer, Director, Business Innovation Dept., CMIC HOLDINGS Co., Ltd.
Flex Databases system is very flexible and user friendly. In addition, most importantly the team have much much flexible ways of thinking! I am very proud that we did choose Flex Databases as our platform in CMIC APAC offices.
Joshua Baisley, H.B.Sc.
VP, Clinical Design and Delivery
As we have begun the installation process for Flex Databases system for use with the Clinical Trial Management group, the team at Flex Databases have made this process efficient and organized along with answering any questions that come up internally and jumping on additional meetings with our team to ensure that everything is understood throughout the set up and training process.
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.
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.