One Platform for Every Sponsor’s Account
Flex Databases gives sponsors a platform they own directly – with continuous oversight and a pipeline view across CROs, vendors and sites instead of relying only on periodic status decks.
4.2
modules per sponsor, avg.
100%
Client & regulatory audits supported
100+
audits passed
21 CFR Part 11
validated
Checking on a study's status
Waiting for the CRO's monthly status deckOpening a live pipeline dashboard
Losing history when a CRO relationship endsKeeping the study record on a sponsor-controlled instance
Reconciling audit trails across vendors before an inspectionConsistent audit history across work managed in the system
Designed to Support Regulated Sponsor Oversight
CROs working in the sponsor-controlled instance use the same configured controls, audit trail and access model across the system.
Electronic signatures, timestamped audit trails and role-based controls are included as standard for studies that require them.
Quality management and information security certification behind every module – the same high standard you already hold your CROs to.
Validation documentation, audit trails and system controls are available to support sponsor qualification, audits and inspection preparation.
You Control Who Sees What in Your Own Portfolio
The part that matters most for a sponsor running multiple CROs on one instance: you decide the access, not the vendor.
Hosting, your choice
Servers in the EU or US, or on your own ones if your data governance policy requires it.
You set each vendor access
Role-based permissions let you decide exactly what each CRO or vendor can see in your pipeline – nothing more.
Backups & continuity
Automatic daily backups and a documented recovery approach help protect study records and support business continuity.
Continuity across CRO changes
With a sponsor-controlled instance, study history remains directly accessible when CRO relationships change.
What makes oversight difficult when you don't run the trial yourself
With a sponsor-controlled instance, study history remains directly accessible when CRO relationships change.
Visibility depends on whoever built this month's report
Without direct access to the operational record, sponsors see a study through whatever slide the CRO chooses to build — not a live view they can interrogate themselves.
COST
Risk surfaces at the status call, not before it
Switching CROs can create a continuity gap
When operational systems are controlled by a CRO, changing vendors can require exports, handover work and reconciliation before the new team has a complete history.
COST
Institutional knowledge lost at every vendor transition
Portfolio-level reporting is a manual roll-up
Aggregating enrollment, site status and risk indicators across multiple CROs and studies usually means multiple exports, stitched together by hand before every board or governance review.
COST
A portfolio view that's outdated the moment it's built
Compliance evidence is distributed across vendor systems
When CROs use separate systems, audit history and supporting records may need to be reconciled across different formats before a sponsor can present a consistent program-level view.
COST
Audit findings that trace back to a vendor’s system, not yours
Managing more than one CRO right now?
We can show what portfolio-level visibility looks like with your actual program structure.
Oversight that belongs to you, not your vendor
The Problem
Visibility depends on the CRO's monthly report
What changes with Flex
Live dashboard the sponsor accesses directly, any time
The Problem
Switching CROs risks losing the record
What changes with Flex
Sponsor-owned instance — data stays regardless of who executes
The Problem
Portfolio reporting is a manual roll-up
What changes with Flex
Aggregated dashboards across every CRO, vendor and study
The Problem
Compliance risk spread across disconnected vendor systems
What changes with Flex
One continuous, timestamped audit trail across the whole program
| The Problem | What changes with Flex |
|---|---|
| Visibility depends on the CRO's monthly report | Live dashboard the sponsor accesses directly, any time |
| Switching CROs risks losing the record | Sponsor-owned instance — data stays regardless of who executes |
| Portfolio reporting is a manual roll-up | Aggregated dashboards across every CRO, vendor and study |
| Compliance risk spread across disconnected vendor systems | One continuous, timestamped audit trail across the whole program |
One Modular Clinical Trial Management Platform - Under Sponsor Control
Use a sponsor-controlled instance rather than depending on any single CRO’s system. Start with the modules your portfolio needs and expand as additional studies and vendors come onto the platform.
Why unified beats "CRO-owned"
One record, wherever the work happens
When any CRO in your program closes a visit or files a document, it becomes part of your own record — not something to request, export, or reconcile later.
CTMS
See site and visit status across every CRO running your studies — in one calendar.
eTMF
One inspection-ready master file, regardless of which CRO filed the documents.
EDC
Keep the data capture layer under sponsor control even when a CRO manages day-to-day site relationships.
Pharmacovigilance
Consolidate safety case handling across every program, under one account.
QMS
Track CAPAs and deviations across your whole portfolio, not just what one CRO reports up.
LMS
Verify training completion across every vendor and site touching your studies.
Project & Budget
See program spend and milestone activity across CROs managed in the platform.
Only need oversight of one thing today?
Start with eTMF or CTMS visibility across your CROs — every other module is already there when your portfolio needs it.
Talk to a specialist →Beyond our own modules
Connects to what your CROs already use
Not every CRO necessarily needs to replace its existing systems. Flex supports integration with common clinical and enterprise systems so relevant data can be exchanged where the external system and integration scope allow it.
What each module means for a sponsor specifically
The same eight modules, read through what actually changes for an organization overseeing multiple CROs.
For CROs working in or connected to the sponsor instance, site activation, visit completion and enrollment can be viewed in a consistent sponsor dashboard across the program.
- Portfolio-wide visit calendar across every CRO
- Site status visible directly, not reported up
- Consistent view even when CROs change mid-program
- Reduces dependence on monthly status decks for operational visibility
Documents filed by any CRO on the program land in the same TMF structure the sponsor owns – so an inspection-ready file doesn’t depend on one vendor’s filing habits.
- One TMF structure across every CRO on the program
- Sponsor retains direct access to the TMF when CRO relationships change
- Completeness visible at the portfolio level
- Reduces TMF handover and reconciliation work when a vendor changes
Case report forms and study data can remain on a sponsor-controlled instance while CROs manage daily site relationships, reducing CRO-driven data migration when vendors change.
- Sponsor-controlled data capture layer
- CROs work in it without owning it
- Consistent data structure across programs
- No re-platforming when a vendor changes
Safety case intake and signal detection sit on the sponsor’s own account, giving one consistent view across programs instead of a separate safety system per CRO or per study.
- Portfolio-wide safety case intake
- Signal detection reporting, aligned to global rules
- Consistent case record when CROs work in the same safety environment
- Shared audit trail with CTMS and eTMF
When quality workflows are managed in Flex, issues raised by CROs or sites can be visible directly to authorized sponsor users instead of relying only on periodic escalation reports.
- CAPAs and deviations visible across every CRO
- Consistent tracking regardless of vendor
- Same audit trail standard as trial data itself
- Supports the sponsor’s own quality audits
When quality workflows are managed in Flex, issues raised by CROs or sites can be visible directly to authorized sponsor users instead of relying only on periodic escalation reports.
- Training completion visible at the portfolio level
- Consistent certification tracking across CROs
- Assigned and monitored from the sponsor’s own account
- Reduces separate confirmation requests where training is managed in Flex
Budgets and invoicing across every CRO read from the same milestone data the sponsor already sees – so program spend is visible directly, not summarized after the fact.
- Portfolio-wide budget visibility
- Milestone-triggered billing, tied to real activity
- Consistent view across every CRO’s invoicing
- Reduces manual finance roll-up across participating studies and CROs
How Pricing Actually Works
Not a number – a logic. Exact figures depend on your portfolio and modules.
Core subscription based on users and modules
Start with eTMF oversight or another single module, then add users and modules as the portfolio scope grows.
One sponsor-controlled instance across programs
One instance covers every CRO and study in your portfolio — not a separate license per vendor.
No penalty for adding a new CRO
Bringing on another CRO does not require a separate Flex platform instance; additional users or modules may affect subscription scope.
Core subscription scope stays tied to the sponsor instance rather than to a specific CRO relationship.
Get exact numbers on a callTypical Sponsor Onboarding
Setting up your own instance — with your CROs working inside it — broken into what happens each stage.
1
Week 1
Kickoff & portfolio mapping
A named implementation lead maps your current programs, CROs and vendors into one instance.
2
Week 2-4
Configuration & CRO access
Access is configured per CRO and per study, so each vendor sees only what they need to.
3
Week 5-6
Training & first live program
Your team and your CROs' teams test real workflows on one active program before full rollout.
4
Go Live
Portfolio-wide visibility
Sponsor dashboards and oversight workflows go live for the agreed initial program scope.
Why Flex Databases, Specifically, for a Sponsor
Every eClinical vendor will hold your trial data. Here's what's different about owning your program on Flex — the module and platform advantages that keep oversight, continuity and the record in your hands. We've built clinical trial software, and only clinical trial software, since 2011, and 100+ organizations across 30+ countries run on it.
Oversight lives in each CRO's system, in each CRO's format, on each CRO's schedule
Your own instance, your record of truth
The sponsor owns the platform — not a seat on a CRO's license. Your studies, your configurations and your history stay with you no matter which CRO runs the work.
When a CRO relationship ends, visibility and audit history often end with it
Continuity across every CRO change
Change vendors without losing your record. Because the instance is yours, oversight and audit history carry across CRO transitions instead of disappearing with the contract.
Portfolio status depends on each CRO's reporting cadence and templates
Live portfolio visibility, day one
See enrollment, timelines, spend and risk across every study, country and CRO in one place — drill from portfolio to a single site, without waiting for anyone's status report.
Giving CROs access means exposing your whole instance or emailing exports
You control who sees what
Role-based permissions by project, country, site and vendor let each CRO see exactly what they should — nothing more — with data never mixing between the partners working your portfolio.
Each module is a separate vendor, contract and integration to govern
CTMS, eTMF, EDC, PV, QMS & PM on one data model
Run your whole program on one platform — an SAE in EDC reaches PV, a signed visit report becomes the eTMF record, safety and quality connect by default, with no integration projects to oversee.
Standing up oversight the enterprise way takes 12–18 months
Live in weeks, not fiscal years
A validated instance with a named implementation lead in 3–10 weeks — you start consolidating oversight this quarter, not after a multi-year enterprise rollout.
Multi-CRO programs make inspection prep a cross-vendor scramble
Validated and inspection-ready by design
Audit trails, e-signatures and a validation package come built in across every module — so an inspection starts from a system that's already ready, not a reconciliation exercise across your CROs.
Enterprise oversight comes with an enterprise price and a multi-year lock-in
Pay for users and modules, nothing else
Subscription is users × modules — projects and sites unlimited, 90-day minimum, sponsor-controlled. Enterprise-grade oversight without the enterprise contract.
With big vendors your requirements are one ticket among thousands
A partner your feedback moves
Client feature requests genuinely reach the roadmap — teams like ABX-CRO name it as a reason they stay. Productive in days, with customer care in touch throughout, not just at onboarding.
Who owns the record
CRO-owned systems
The CRO
Flex Databases
You do!
Legacy enterprise suite
You, eventually — after a long rollout
Continuity across CRO changes
CRO-owned systems
Frequently lost
Flex Databases
Fully retained
Legacy enterprise suite
Retained, at high switching cost
Time to full portfolio visibility
CRO-owned systems
Depends on each CRO's reporting
Flex Databases
Live from day one
Legacy enterprise suite
12–18 months
Full eClinical stack
CRO-owned systems
Varies by CRO
Flex Databases
CTMS, eTMF, EDC, PV, QMS, PM in one
Legacy enterprise suite
Broad, but slow and rigid
Access control across vendors
CRO-owned systems
All-or-nothing exports
Flex Databases
Role-based, per CRO, no data mixing
Legacy enterprise suite
Present, configuration-heavy
Contract flexibility
CRO-owned systems
Tied to CRO relationship
Flex Databases
Users × modules, 90-day minimum
Legacy enterprise suite
Multi-year
| CRO-owned systems | Flex Databases | Legacy enterprise suite | |
|---|---|---|---|
| Who owns the record | The CRO | You do! | You, eventually — after a long rollout |
| Continuity across CRO changes | Frequently lost | Fully retained | Retained, at high switching cost |
| Time to full portfolio visibility | Depends on each CRO's reporting | Live from day one | 12–18 months |
| Full eClinical stack | Varies by CRO | CTMS, eTMF, EDC, PV, QMS, PM in one | Broad, but slow and rigid |
| Access control across vendors | All-or-nothing exports | Role-based, per CRO, no data mixing | Present, configuration-heavy |
| Contract flexibility | Tied to CRO relationship | Users × modules, 90-day minimum | Multi-year |
Support for Sponsor Oversight
Not a ticket queue — the people who know your whole portfolio.
A named implementation lead
One person who understands your whole portfolio, not just a single study or CRO relationship.
Response times that matter for oversight
Clear response expectations for anything blocking portfolio-level reporting or a CRO handover.
Training for your team and your CROs
Both sides of the relationship get trained on the platform, not just your internal staff.
A say in what gets built next
Feature requests go to the product team and get reviewed — not filed away and forgotten.
The questions sponsors actually ask before switching
““Will our CRO actually adopt a system we choose, not them?””
CROs already run their own accounts on Flex
Because the platform is built for multi-account use, CROs typically onboard a sponsor-mandated instance the same way they would any client system — with implementation support included on both sides.
““Isn't a large, established enterprise vendor the safer choice for a sponsor our size?””
Safety comes from validation, not vendor size
21 CFR Part 11 validation, ISO 9001 and ISO 27001 certification, and 100+ successful audits are the same compliance bar large vendors are held to — without the multi-year rollout that often delays the program starting oversight in the first place.
““What's the risk in migrating data from our current legacy platform?””
Migration is scoped and supported, not assumed
Historical study data, documents and audit trail entries are migrated as a defined project with validation checkpoints, not a bulk export you're left to reconcile yourself.
““Is a smaller vendor a bigger business-continuity risk for us?””
Fifteen years and 100+ audits is the track record, not a promise
The company has been building validated eClinical systems for 15 years, currently supports over 20,000 daily users, and has passed 100+ regulatory and client audits — evidence, not reassurance.
Consolidating Oversight Onto Your Own Instance, Without Disrupting Live Programs
Most sponsors don't move every historical program at once — here's the usual path.
1
STEP 1
Start with your next program
Most sponsors begin by putting a new study or a new CRO relationship onto their own Flex instance, rather than migrating every program at once.
2
STEP 2
Existing CRO data comes over on your schedule
When you're ready to consolidate history from a CRO-owned system, it's migrated as a planned project with validation checkpoints.
3
STEP 3
Nothing joins your record unchecked
Migrated data is verified against the original records before it becomes part of your portfolio's record of truth.
Sponsors overseeing multi-CRO programs 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
30+
Countries
Implementation
Over 26 years at Agenus, this was the smoothest and fastest validated IT system implemented.
Craig Winter
CIO, Agenus Inc.
Safety oversight
Managing safety data across the program depends on technology — now handled in one place.
Head of Clinical Safety
CIO, Agenus Inc.
Reporting control
Building custom reports without a developer ticket is a major advantage for working with portfolio data.
Tameo Kobayashi
Chief Innovation Officer, CMIC Holdings
Recent partnership stories
A few of the organizations that recently chose Flex Databases, in their own words.
Frequently asked by sponsors
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.