Efficient Implementation

We can deliver a fully functional system in the timeframe from 3 to 10 (typically around 5) weeks, depending on the Client’s involvement and the complexity of the Client’s requirements.

Contract sign-off

Flex DBS: Define project scope Create project plan Assign project team

Kick-off

Flex DBS & Client:
Kick-off meeting – agree on implementation plan.
Client: Assign SMEs

Analysis stage

Flex DBS & Client: Agree on system requirements & configuration.

System acceptance

Client: Go through UAT for GxP modules and complete end-user validation, confirm release of product environment.

Training

Flex DBS & Client: Conduct and complete face-to-face or online training

QA environment

Flex DBS: Deliver QA environment

Product environment

Flex DBS: Deliver product environment

System successfully
implemented and
validated

Icon

Estimated timeline for implementation is from 3 to 10 weeks, depending on the complexity of client’s requirements and client’s involvement.

Our Products

CTMS

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.
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eTMF

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.
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PM & Budgeting

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.
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Pharmacovigilance

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.
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LMS & QMS

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.
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Discover more about

our clients

October 16, 2024
Why Agenus Chose Flex Databases: A Client’s Perspective

October, 2024 – Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a strong pipeline of immune modulating antibodies, together with Flex Databases announce the successful implementation of Flex Databases’ Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) solutions, including a new AI-driven feature for automated document filing and metadata assignment. This partnership […]

October 3, 2024
Client Spotlight: FGK Clinical Research GmbH CRO’s Experience with Flex Database

We had the pleasure of sitting down with Martin Krauss, Co-Founder and Managing Director of FGK CRO, to discuss how Flex Databases has supported their clinical research operations over the past 3.5 years.In this interview, Martin shares: • Why FGK CRO initially chose to partner with Flex Databases.• How our CTMS, TMF, and LMS solutions have transformed […]

August 12, 2024
Metronomia Partners with Flex Databases for TMF Module to Support Biotech Client

Metronomia, a leading Data Management and Biostatistics CRO in EU, has selected Flex Databases’ eTMF module to support one of its biotech clients. Simon Rückinger, Managing Director at Metronomia Clinical Research GmbH, explained their decision and what they expect from the partnership. “We needed a flexible and simple eTMF solution that could meet the specific […]

February 22, 2024
How we implemented eTMF & developed SOPs in 3 weeks for iRenix

Last year, right around this time, we implemented an eTMF for a California-based Medical Device company, iRenix. Our target? A swift 3-week completion, so everything was up and running before their FPI. Now, this is quite the sprint compared to the usual 5-6 weeks! And here’s the twist – while iRenix was laser-focused on their […]

Contact us

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! 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.