Built by researchers, for researchers
One eClinical platform with everything a CRO needs — CTMS, eTMF, EDC, safety, quality and training tools, all in one place. Built by people who used to run trials on spreadsheets themselves. Turn on the modules a study needs today. If a client already uses another system, we connect to it easily — no extra work for your team.
2–6 wks
to onboard a new sponsor
90 days
minimum contract
100+
CROs, sponsors & biotechs
21 CFR 11
validated
Onboarding a new sponsor
Scoping a dedicated platform build for the new accountConfiguring a new study on existing infrastructure
Training staff on yet another sponsor-owned systemSame interface, new study parameters
Waiting months before the account bills revenueLive and billable within weeks
Validated the way your sponsors already expect
Every account you onboard inherits the same compliance foundation — you're not re-proving it client by client.
Electronic signatures and timestamped audit trails built into the base system, not a paid add-on for the sponsors who require it.
Quality management and information security certification behind every module — the same bar sponsors hold their own vendors to.
A track record across client and regulatory audits, so "who validated this?" has an answer before a sponsor asks it.
Security and Data Isolation, in Plain Terms
The part that matters most for a CRO: multiple sponsors' data lives on the same platform without ever mixing.
Hosting, where you need it
Cloud hosting in the EU or US, or run it on your own servers if a client's policy requires it.
Data protection
Information is protected both while it's stored and while it moves between your team and ours.
Backups & continuity
Automatic daily backups and a recovery plan, so a technical failure never means a lost study record.
Separation between sponsors
Each sponsor's studies are kept fully separate from every other, even on shared infrastructure — one account can never see another's data.
What actually slows a CRO down isn't the science — it's the stack
None of this shows up in the pitch deck. It shows up three weeks into delivery, when a fifth system needs a login, and nobody remembers why the last one was chosen.
Every sponsor insists on their own process — and you rebuild it from zero
One sponsor wants a five-step monitoring sign-off, another wants two. Without a shared, configurable core, "onboarding a new client" quietly becomes "standing up a new platform" — and that cost comes straight out of the margin the contract was supposed to protect.
COST
Weeks of unbillable setup before a study can start
Your best CRAs relearn a new system every time they switch accounts
When each sponsor licenses its own CTMS, your monitors carry three or four logins in their head at once — and the skill they've built on one platform is worthless the moment they open the next one.
COST
Onboarding time repeated for every hire, on every client
You lose bids to CROs who can just show the system, live
RFPs now routinely ask what CTMS and eTMF capability you bring to the table. Answering "we'll license something once we win" reads very differently from opening a validated, working platform on the call.
COST
Bids lost to competitors who could demonstrate, not describe
Bidding on an account that needs this next quarter?
We can usually scope what a new sponsor's study needs before the contract is even signed.
Configurable per study, standardized underneath
The Problem
Every sponsor needs a different workflow
What changes with Flex
Per-study configuration, no custom development required
The Problem
Staff relearn a new system per client
What changes with Flex
One interface across every account, new study parameters only
The Problem
Reports rebuilt per sponsor's format
What changes with Flex
Self-service report builder, exportable to any format sponsors need
The Problem
Proving capability before the contract is signed
What changes with Flex
A live, validated demo scoped to the prospect's protocol in days
| The Problem | What changes with Flex |
|---|---|
| Every sponsor needs a different workflow | Per-study configuration, no custom development required |
| Staff relearn a new system per client | One interface across every account, new study parameters only |
| Reports rebuilt per sponsor's format | Self-service report builder, exportable to any format sponsors need |
| Proving capability before the contract is signed | A live, validated demo scoped to the prospect's protocol in days |
One Modular Clinical Trial Management Platform — Add Tools as You Need Them
This is what actually helps a CRO grow: not seven separate tools stuck together, and not one rigid system that forces every client to work the same way. It's one flexible clinical trial management platform. Turn on only the tools a study needs. Add more the moment a new client needs them.
Why unified beats "integrated"
One shared record, not a copy
When a visit is closed in CTMS, the signed report becomes the eTMF record automatically — not a copy of it. Nothing to export by hand. Nothing to double-check before an audit.
CTMS
Site visits, payments and milestones — the same calendar across every client account.
eTMF
A fully exportable, inspection-ready master file per sponsor, filed automatically as work happens.
EDC
Build case report forms per protocol without waiting on a developer sprint.
Pharmacovigilance
Add safety case handling for any client that needs it, without a separate vendor contract.
QMS
CAPAs and deviations tracked with the same audit trail as the trial data itself.
LMS
Assign and certify site and CRA training per study, inside the same login.
Project & Budget
Tie study budgets to tasks and milestones, with CRO and sponsor invoicing views.
DMS
Store and manage corporate and study documents outside the TMF, with the same access controls and audit trail.
Only need one module today?
Start with CTMS or eTMF alone — every other module is already there when a client needs it.
Talk to a specialist →Beyond our own modules
Connects to what your client already uses
Not every sponsor needs to move everything onto Flex — and they don't have to. Our platform connects easily to other systems your client already has, like their finance or data systems, so information flows between them without anyone re-typing it by hand.
What each module means for a CRO specifically
The same seven modules, read through what actually changes for an organization running multiple sponsor accounts.
CRAs covering multiple sponsors work from one visit calendar and one report template engine, with each study's sign-off steps configured independently. Workload and performance metrics roll up across accounts, so resourcing decisions aren't guesswork.
- One CRA login across every sponsor account
- Per-study visit workflow, no shared bottleneck
- Cross-account CRA workload and performance view
- Offline visit reporting for low-connectivity sites
CROs can reuse a TMF Reference Model-aligned structure and configure it for each study, with filing supported by connected CTMS activity. At handover, the sponsor can receive an exportable TMF with its associated metadata and history.
- Auto-filing from completed CTMS activity
- TMF Reference Model-aligned structure by default
- Exportable handover at contract end
- Completeness and quality checks available throughout the study
Case report forms and ePRO instruments can be configured per protocol without development, allowing prospective sponsors to review a working study setup during evaluation.
- Protocol-specific CRFs without custom development
- Working demo environment for RFP evaluations
- Consistent site training across studies
- Connected to CTMS visit and subject records
When a sponsor’s scope includes safety reporting, the PV module can be enabled within the same platform, with case workflows connected to relevant study data where configured.
- Single case intake across every account
- Signal detection reporting, aligned to global rules
- Shared audit trail with CTMS and eTMF
When CAPAs and deviations are managed differently for each client, CRO-wide quality oversight becomes harder. A shared QMS provides consistent, timestamped records across internal and sponsor-facing processes.
- Consistent CAPA and deviation tracking, account to account
- Reusable SOP library across the organization
- Same audit trail standard as client-facing modules
- Supports CRO quality audits as well as sponsor oversight
Platform training happens once, at hire. Protocol-specific certification is then assigned per study inside the same login, so ramping a CRA onto a new account is a training assignment, not a new-system onboarding project.
- One platform onboarding for every new hire
- Per-study, per-protocol certification tracking
- Site training assigned and tracked centrally
- Reduced repeated system training across sponsor accounts
Budget templates from a previous account shorten the next proposal, and once a study is live, both the CRO’s internal invoicing view and the sponsor-facing view read from the same milestone data — no separate finance spreadsheet to keep in sync.
- Reusable budget templates across new proposals
- Separate CRO and sponsor invoicing views
- Milestone-triggered billing, tied to real activity
- Faster time from signed contract to first invoice
How Pricing Actually Works
Not a number — a logic. Exact figures depend on your modules and account structure.
Priced by module, not by promise
Pay only for the modules turned on for a given account — CTMS alone, or the full stack, priced accordingly.
Licensed per study or per account
Pick whichever fits the engagement, so a small pilot project isn't priced like an enterprise-wide rollout.
No penalty for growing your team
Adding more CRAs or site staff to a live study doesn't trigger a surprise new pricing tier.
Costs can be passed through to the sponsor, absorbed into overhead, or split — whatever the account's commercial structure requires.
Get exact numbers on a callWhat Onboarding Actually Looks Like
The 2–6 week window we quote elsewhere, broken into what actually happens each stage.
1
Week 1
Kickoff & mapping
A named implementation lead maps your sites, contacts and study structure into the platform.
2
Week 2-4
Configuration
Visit workflows, report templates and approval steps are set up to match the sponsor's protocol.
3
Week 5-6
Training & testing
Your team tries real workflows before go-live, with training scoped to each role.
4
Go Live
Live and billable
The account goes live, ready for its first monitoring visit — on schedule, not "eventually."
Why Flex Databases, Specifically, for a CRO
Every eClinical vendor will run your trials. Here's what's different about running your whole business on Flex — the module and platform advantages that actually change a CRO's economics. We've built clinical trial software, and only clinical trial software, since 2011, and 100+ organizations across 30+ countries run on it.
Every new sponsor means re-platforming, re-validating, re-training from scratch
One platform, configured per client
Every sponsor account runs on the same validated instance, configured per study instead of rebuilt per client — so a new account is a 2–6 week configuration, not a months-long implementation project each time.
Each module is a separate vendor, contract and integration to manage
CTMS, eTMF, EDC, PV, QMS & PM on one data model
Offer sponsors a full eClinical stack from a single platform — a visit closed in CTMS becomes the eTMF record, an SAE in EDC reaches PV, with no integration projects and no second vendor to manage or mark up.
Reporting across sponsors means manually reconciling exports from every tool
Cross-account oversight, per client
See status, timelines and KPIs across every sponsor and study in one place — and give each client their own walled view, with data never mixing between accounts.
The sponsor owns the license, so you lose access when the relationship ends
You own the platform relationship
It's the CRO's own instance, not a seat on a sponsor's license — your processes, your configurations and your history stay with you across every client change.
Adding a module or a sponsor triggers a new enterprise negotiation
Pay for users and modules, nothing else
Subscription is users × modules — projects and sites are unlimited, so onboarding a new sponsor or spinning up more studies never inflates the bill. 90-day minimum, not a multi-year lock-in.
Configuration changes wait in a vendor's development queue
Configured by your team, not coded by us
Workflows, reports, budget templates and views are under your team's control — you tailor the system to each sponsor's SOPs without raising a change request or paying professional services.
Multi-sponsor validation and inspection prep eats your quality team alive
Validated and inspection-ready by design
Audit trails, e-signatures and a validation package come built in — so every sponsor's audit and every regulatory inspection starts from a system that's already ready, not a scramble.
Margins leak into re-keyed data, manual invoicing and untracked utilization
The business side is built in too
PM & Budgeting turns proposals into plans and invoices without re-entry, tracks earned value and FTE utilization, and shows profitability per client and per project — so growth stays profitable, not just busy.
With big vendors you're one account among thousands, and your requests vanish
A partner your feedback moves
Client feature requests genuinely reach the roadmap — CROs like ABX-CRO name it as a reason they stay. Productive in days with customer care in touch throughout, not just at onboarding.
New account onboarding
Patchwork of point tools
Weeks per tool, per account
Flex Databases
2–6 weeks, one platform
Enterprise suite, sponsor-mandated
Locked to what the sponsor licenses
Full eClinical stack
Patchwork of point tools
Multiple vendors to assemble
Flex Databases
CTMS, eTMF, EDC, PV, QMS, PM in one
Enterprise suite, sponsor-mandated
Broad, but rigid and sponsor-scoped
Cross-account reporting
Patchwork of point tools
Manually reconciled
Flex Databases
Native, exportable per client
Enterprise suite, sponsor-mandated
Usually not available to the CRO
Configuration control
Patchwork of point tools
Varies per vendor
Flex Databases
Your team, no code, no PS fees
Enterprise suite, sponsor-mandated
Change request to the vendor
Contract flexibility
Patchwork of point tools
Varies per vendor
Flex Databases
Users × modules, 90-day minimum
Enterprise suite, sponsor-mandated
Multi-year, sponsor-controlled
Own the platform relationship
Patchwork of point tools
Fragmented across vendors
Flex Databases
Yes — CRO's own instance
Enterprise suite, sponsor-mandated
No — sponsor owns the license
| Patchwork of point tools | Flex Databases | Enterprise suite, sponsor-mandated | |
|---|---|---|---|
| New account onboarding | Weeks per tool, per account | 2–6 weeks, one platform | Locked to what the sponsor licenses |
| Full eClinical stack | Multiple vendors to assemble | CTMS, eTMF, EDC, PV, QMS, PM in one | Broad, but rigid and sponsor-scoped |
| Cross-account reporting | Manually reconciled | Native, exportable per client | Usually not available to the CRO |
| Configuration control | Varies per vendor | Your team, no code, no PS fees | Change request to the vendor |
| Contract flexibility | Varies per vendor | Users × modules, 90-day minimum | Multi-year, sponsor-controlled |
| Own the platform relationship | Fragmented across vendors | Yes — CRO's own instance | No — sponsor owns the license |
What Support Actually Includes
Not a ticket queue — the people who know your account.
A named implementation lead
One person who knows your account and its history, not a rotating queue of unfamiliar reps.
Response times that matter mid-trial
Clear response expectations for anything blocking a monitoring visit or a payment — not "we'll get to it."
Training included
New hires and new roles get trained as part of the relationship, not billed as a separate line item.
A say in what gets built next
Feature requests go to the product team and get reviewed — not filed away and forgotten.
The questions CROs actually ask before switching
““We already have a CTMS from another vendor — switching feels expensive””
Migration is scoped, not assumed
Most engagements start with one new account rather than a full cutover, so existing contracts run their course while new business goes live on Flex. Data migration support is included when a full switch does make sense.
““Will a large sponsor trust a platform they didn't choose themselves?””
Validation status speaks before the sales conversation does
Every module is validated to 21 CFR Part 11 with ISO 9001 and ISO 27001 certification behind it, and 100+ audits passed — the same compliance bar sponsors already require from any vendor.
““Can we bill this differently across clients with different contract structures?””
Licensing is modular by design
Modules and users are licensed at the study or account level, so costs can be passed through to the sponsor, absorbed into overhead, or split — whatever the account's commercial structure requires.
““What happens to our data if a sponsor's account ends?””
Data segregation is structural, not procedural
Role-based access and data partitioning isolate each sponsor's studies even on shared infrastructure, so closing one account never exposes or entangles another's data.
Switching From Another System, Without Disrupting a Live Study
Most CROs don't do a single big-bang cutover — here's the usual path.
1
STEP 1
New business goes first
Most CROs start by running new sponsor accounts on Flex, while existing contracts finish out on their current system — no forced cutover.
2
STEP 2
Historical data moves on your schedule
When a full switch makes sense, study data and documents are migrated as a planned project, not a bulk export you're left to sort out.
3
STEP 3
Nothing goes live unchecked
Migrated data is verified against the original records before an account fully cuts over.
CROs running multiple sponsor accounts on Flex
15+
Years of operations
500+
Companies using Flex Databases
45,000+
Users across the globe
100+
Clients
20,000+
Daily active users
10m+
Documents
2,000+
Clinical trials
40+
Countries
Clear structure
FGK Clinical Research chose Flex CTMS for its clear structure, easy-to-use interface, and offline access for CRAs working in the field.
Martin Krauss
Managing Director, FGK Clinical Research
Grows with you
As a boutique CRO, Sourcia values being able to add modules step by step, without losing the simplicity of one system.
Claudia Gruber
Director Clinical Operations, Sourcia
Fair, transparent pricing
WSG points to the option to add modules like budgeting, combined with clear and fair pricing, as what made the difference.
Michael Städele
Director, Business Development & Operations, WSG
Recent partnership stories
A few of the organizations that recently chose Flex Databases, in their own words.
Frequently asked by CROs
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.