Clinical operations, configured with control

Operational control across the complete CRO-to-Site study lifecycle.

Design the operational study, simulate intended Site roles, deploy the approved model, and maintain traceable oversight across execution, issues, and multicenter progress.

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Synthetic Fonte Clínica Protocol Builder and Runtime Simulation workspace

Clinical studies become difficult when design and execution drift apart.

01

One study. Too many interpretations.
Protocols, responsibilities, forms, and operational rules often become fragmented across documents and systems. Fonte Clínica brings them together in one structured study model.

02

Problems discovered too late.
Access conflicts, unclear responsibilities, and missing workflow steps often appear only after implementation begins. Fonte Clínica makes them visible before deployment.

03

Deployment should not end CRO control.
Once a study reaches the Sites, progress, issues, documents, and decisions can become difficult to follow. Fonte Clínica keeps Site execution connected to continuous CRO oversight.

Why Fonte Clínica

From fragmented handoffs to one continuous clinical operating model.

Clinical operations often span separate documents, systems, messages, and manual handoffs. Fonte Clínica keeps the approved operational model connected from study design through Site execution and CRO oversight.

Fragmented handoffs

Rules and responsibilities remain distributed across documents and systems.

Operational conflicts emerge during implementation.

Site activity returns through disconnected channels and manual interpretation.

Fonte Clínica

One continuous operating model

Protocol intent and role outcomes can be inspected before deployment.

Approved operational logic carries forward into Site execution.

Issues, actions, and Site progress return as traceable CRO oversight.

Abstract controlled clinical operating model pathway

Platform

From protocol intent to operational continuity.

Design, simulate, deploy, execute, resolve, audit, and improve inside one connected operating model.

Coming soon

Protocol Builder

In CRO Pro, structure protocol requirements, roles, responsibilities, visits, forms, documents, and review metadata in one controlled study configuration.

Request a demo

Request a demo

Coming soon

Protocol Builder

In CRO Pro, structure protocol requirements, roles, responsibilities, visits, forms, documents, and review metadata in one controlled study configuration.

Request a demo

Request a demo

Coming soon

Protocol Builder

In CRO Pro, structure protocol requirements, roles, responsibilities, visits, forms, documents, and review metadata in one controlled study configuration.

Request a demo

Request a demo

Coming soon

Runtime Simulation

In CRO Pro, simulate intended Coordinator, PI, CRA, Doctor, and Nurse views to inspect permissions, responsibilities, requirements, and warnings before deployment.

See the platform

See the platform

Coming soon

Runtime Simulation

In CRO Pro, simulate intended Coordinator, PI, CRA, Doctor, and Nurse views to inspect permissions, responsibilities, requirements, and warnings before deployment.

See the platform

See the platform

Coming soon

Traceable Site execution

Deploy the approved study configuration to the Site environment for role-based execution, with visits, documents, issues, and operational status returning to CRO oversight.

Discuss your workflow

Discuss your workflow

Coming soon

Traceable Site execution

Deploy the approved study configuration to the Site environment for role-based execution, with visits, documents, issues, and operational status returning to CRO oversight.

Discuss your workflow

Discuss your workflow

Coming soon

Traceable Site execution

Deploy the approved study configuration to the Site environment for role-based execution, with visits, documents, issues, and operational status returning to CRO oversight.

Discuss your workflow

Discuss your workflow

Platform

One platform across the operational study lifecycle.

Configure, validate, deploy, execute, resolve, and oversee through one connected operating model.

Request a demo

Request a demo

Request a demo

Request a demo

Synthetic clinical study role and responsibility matrix

Study configuration

Define the study structure, requirements, roles, responsibilities, visits, forms, and documents before deployment.

Role-based simulation

Review intended role visibility, permissions, required steps, and responsibility boundaries before the study is deployed.

Controlled deployment

Deploy the approved study configuration from CRO Pro to authorized Site teams without rebuilding roles, requirements, or study context.

Role-based Site execution

Enable authorized Site teams to complete startup tasks, visits, documents, and assigned responsibilities within the deployed study configuration.

Linked issues and responses

Link post-deployment issues, queries, operational flags, CRA findings, authorized Site responses, and resolutions to the relevant Study, Site, visit, form, document, or startup requirement.

CRO operational visibility

Give CRO teams visibility into study and center readiness, deployment state, operational status, and unresolved findings or queries, with authorized actions retained in audit history.

CRO Pro & Site

One operating model. Two connected environments.

CRO ENVIRONMENT

CRO Pro

The CRO command environment where teams configure the Clinical Study Protocol, validate role expectations, prepare controlled deployment, and oversee multicenter execution across participating Sites.

SITE ENVIRONMENT

Site

The Site execution environment where authorized teams complete startup tasks, visits, documents, protocol responsibilities, issues, reviews, and traceable study actions.

Configure and validate the operational study model in CRO Pro. Execute protocol-defined workflows through authorized Site teams. Keep readiness status, CRA review findings, queries, Site Coordinator responses, documents, and operational evidence connected to the relevant study context and CRO oversight.

Discuss your operating model

Discuss your operating model

Discuss your operating model

Discuss your operating model

Security & Trust

Trust begins with clear boundaries and controlled responsibility.

How does Fonte Clínica control user access?

Fonte Clínica uses authenticated user accounts and evaluates access through CRO membership, Site role, Study assignment, center context, and deployment state. Database policies and controlled backend functions restrict access to records and operations in inspected workflows: CRO roles manage configured study lifecycles, while authorized Site roles operate within eligible Study and Site contexts. Issue, document, audit, and aggregate activity views apply contextual checks, and selected workflows record the acting user. These controls support separation between CRO Pro oversight and Site execution. Customer identity governance, role assignment, access review, offboarding, and SOPs remain customer responsibilities.

How does Fonte Clínica protect patient confidentiality?

Fonte Clínica is designed around data minimization, pseudonymized patient identifiers, and controlled Study and Site access. Patient-level information remains limited to authorized operational contexts according to role responsibilities.

What is Runtime Simulation?

Runtime Simulation is a temporary pre-deployment inspection environment where CRO teams can evaluate intended roles, visibility, permissions, requirements, warnings, and workflow behaviour before deployment. It does not create live Site records, patient data, or operational changes and is not formal computerized-system validation.

Which actions are traceable?

Authorized operational actions can remain attributable in audit history to the responsible user, timestamp, Study or Site context, and affected record, including related issues, queries, findings, responses, reviews, approvals, and workflow events.

How does Fonte Clínica approach Part 11 and validation?

Fonte Clínica is designed with implemented control foundations addressing applicable FDA 21 CFR Part 11 domains and Good Clinical Practice expectations for trustworthy clinical-trial records. These foundations include authenticated and attributable users, scoped authorization, controlled workflow transitions, timestamped audit and activity history, versioned and locked protocol records, contextual issue, query, review, approval, and deployment history, and a scoped backend foundation for electronic approvals and signatures. They support controlled collection and review of operational study data, traceability, scoped record protection and retrieval, and patient-data minimization in aggregate views across CRO Pro and role-based Site execution. These capabilities do not by themselves establish Part 11 compliance or a validated system. Validation must be risk-based and specific to intended use. Retention, archival, backup and recovery, SOPs, training, infrastructure controls, certified copies, and inspection procedures must be defined, tested, documented, and maintained for each deployment.

How do CRO Pro and Site relate?

CRO Pro structures, simulates, deploys, and oversees the operational study model. Site provides the role-specific execution environment for protocol-defined activities. Progress, issues, documents, queries, and operational evidence return to CRO oversight through the connected platform.

How does Fonte Clínica control user access?

Fonte Clínica uses authenticated user accounts and evaluates access through CRO membership, Site role, Study assignment, center context, and deployment state. Database policies and controlled backend functions restrict access to records and operations in inspected workflows: CRO roles manage configured study lifecycles, while authorized Site roles operate within eligible Study and Site contexts. Issue, document, audit, and aggregate activity views apply contextual checks, and selected workflows record the acting user. These controls support separation between CRO Pro oversight and Site execution. Customer identity governance, role assignment, access review, offboarding, and SOPs remain customer responsibilities.

How does Fonte Clínica protect patient confidentiality?

Fonte Clínica is designed around data minimization, pseudonymized patient identifiers, and controlled Study and Site access. Patient-level information remains limited to authorized operational contexts according to role responsibilities.

What is Runtime Simulation?

Runtime Simulation is a temporary pre-deployment inspection environment where CRO teams can evaluate intended roles, visibility, permissions, requirements, warnings, and workflow behaviour before deployment. It does not create live Site records, patient data, or operational changes and is not formal computerized-system validation.

Which actions are traceable?

Authorized operational actions can remain attributable in audit history to the responsible user, timestamp, Study or Site context, and affected record, including related issues, queries, findings, responses, reviews, approvals, and workflow events.

How does Fonte Clínica approach Part 11 and validation?

Fonte Clínica is designed with implemented control foundations addressing applicable FDA 21 CFR Part 11 domains and Good Clinical Practice expectations for trustworthy clinical-trial records. These foundations include authenticated and attributable users, scoped authorization, controlled workflow transitions, timestamped audit and activity history, versioned and locked protocol records, contextual issue, query, review, approval, and deployment history, and a scoped backend foundation for electronic approvals and signatures. They support controlled collection and review of operational study data, traceability, scoped record protection and retrieval, and patient-data minimization in aggregate views across CRO Pro and role-based Site execution. These capabilities do not by themselves establish Part 11 compliance or a validated system. Validation must be risk-based and specific to intended use. Retention, archival, backup and recovery, SOPs, training, infrastructure controls, certified copies, and inspection procedures must be defined, tested, documented, and maintained for each deployment.

How do CRO Pro and Site relate?

CRO Pro structures, simulates, deploys, and oversees the operational study model. Site provides the role-specific execution environment for protocol-defined activities. Progress, issues, documents, queries, and operational evidence return to CRO oversight through the connected platform.

See how Fonte Clínica connects protocol planning, Site execution, and CRO oversight through one operational platform.

Explore Protocol Builder, Runtime Simulation, controlled deployment, and traceable clinical trial workflows.

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Synthetic protocol configuration to future Site workflow