Live in 3 to 10 Weeks. Typically Around 5.

We provide a fully functional system tailored to the Client’s needs, with implementation timelines depending on the complexity of the project and the Client’s level of involvement. Full training and ongoing support are included.

3-10 wks

kickoff to production

~5 wks

typical timeline

Simple

a clear, defined path

1 team

named, yours throughout

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Fdagamp 5iso 9001ichiso 27001hiipa

A Simple, Predictable Path to Go-Live

No surprises, no black box. A short sequence of clear steps — each with one owner and a defined finish line — so you always know exactly where the project stands and what comes next.

1

Contract sign-off

Week 1

2

Kick-off

Week 2

3

Analysis

Weeks 3-4

4

QA environment

Weeks 5-6

5

Acceptance & UAT

Weeks 7-8

6

Training

Week 9

7

Production

Week 10

Validated & live

Go live

We do it

Together

Your team

1.

Flex Databases

Contract sign-off

We define the project scope, create the project plan, and assign your dedicated project team — so work starts against a plan, not a blank page.

2.

Flex & Client

Kick-off

A kick-off meeting to agree on the implementation plan together. You assign your subject-matter experts (SMEs) so the right people are involved from day one.

3.

Flex & Client

Analysis stage

Together we agree on system requirements and configuration — tailoring the platform to your SOPs, workflows and study types, not the other way around.

4.

Flex Databases

QA environment

We deliver a fully configured QA environment — your first hands-on look at the system built to your requirements, ready for acceptance.

5.

Client

System acceptance

You run UAT for the GxP modules and complete end-user validation, then confirm release of the production environment — your sign-off, your control.

6.

Flex & Client

Training

We conduct and complete training — face-to-face or online — so your team is productive from the moment the system goes live, not learning on the job.

7.

Flex Databases

Production environment

We deliver the production environment. The system is successfully implemented and validated — and your team gets to work.

Implemented & validated

A validated production system, a trained team, and a validation package on the shelf for your audits.

Who Does What?

Implementation is a partnership with clear lanes — here's how the work splits so nothing falls between the two sides.

What Flex Databases does

  • Defines project scope and builds the project plan
  • Assigns a named, dedicated project team
  • Configures the system to your agreed requirements
  • Delivers the QA environment for acceptance
  • Conducts training, face-to-face or online
  • Delivers the validated production environment
  • Hands over the validation documentation package

What we'll need from you

  • Assign subject-matter experts (SMEs) at kick-off
  • Agree on system requirements and configuration with us
  • Run UAT for the GxP modules
  • Complete end-user validation
  • Confirm release of the production environment
  • Take part in training sessions

Your level of involvement is the single biggest factor in how close to the 3-week end of the range you land.

You're Never Handed Off to a Ticket Queue

From the first kick-off call onward, you have a dedicated Customer Success Manager and a named project team — real people who know your configuration, your studies and your name. When onboarding ends, they don't disappear: the same team stays your point of contact for the life of the partnership.

It's the reason clients name support as a deciding factor again and again — fast, tailored and human, in the US, Europe and Asia.

See what clients say about our support

A dedicated CSM

One named person who owns your relationship, not a rotating inbox.

The same team, before and after go-live

The people who implemented your system stay your contacts.

Support across three regions

US, Europe and Asia — a phone call away in your time zone.

Your feedback reaches the roadmap

Feature requests are taken seriously and genuinely get built.

Why Weeks, Not Fiscal Years

Enterprise eClinical rollouts are measured in quarters. Here's why ours isn't.

Configured, not custom-coded

The platform is configured to your requirements by people who do this every week — there's no bespoke development project standing between sign-off and go-live.

One platform, one validation

Because the modules share one data model, you validate one system — not a stack of separately integrated tools each with its own rollout.

A named team, not a queue

You get a dedicated project team with a plan from day one, so progress depends on the plan and your involvement — not on a support backlog.

What Gets Implemented

Start with one module or the whole platform — the same disciplined process applies either way.

CTMS

CRA activities, patients' data, sites and invoicing in real time.

Learn more →

eTMF

Complete visibility into trial documentation, audit-ready by default.

Learn more →

EDC

Zero-code eCRFs with built-in RTSM, ePRO and RBM — live in under 3 weeks.

Learn more →

Pharmacovigilance

Case processing, E2B(R3) submissions and signal detection in one system.

Learn more →

LMS & QMS

SOPs, audits, CAPA and training in one closed quality loop.

Learn more →

PM & Budgeting

Budgets to plans to invoicing, with earned value and utilization.

Learn more →

AI in Clinical Trials

Validated AI for TMF filing, coding and signal detection — under human oversight.

Learn more →

Implementations, in Clients' Words

"I have been with Agenus for over 26 years. Over those 26 years, our Flex CTMS and TMF implementation is the smoothest and fastest implementation of a validated IT system we have done."

Craig Winter

CIO, Agenus Inc.

"We have been working with Flex Databases for our internal project management and budgeting and their eTMF solution also convinced us. The Flex Databases team was incredibly helpful with setting the system up in no time."

Cheryl Marron

Manager Clinical Operations, Calian

"The team at Flex Databases have made this process efficient and organized, jumping on additional meetings with our team to ensure that everything is understood throughout the set up and training process."

Joshua Baisley

VP, Clinical Design and Delivery, Nutrasource

Implementation: Frequently Asked Questions

Talk to us. See it yourself

Skip the generic demo. A specialist who works with this platform every day will walk you through it live, answer the hard questions directly, and show you exactly how it would run in your organization — not a script, not a slide deck.