For sponsors and CROs, at every trial phase
Run complex clinical trials from one executable protocol.
ProtoCore turns the protocol into study configuration, site and subject workflows, native data capture, treatment coordination, and current sponsor oversight, all within one governed operating environment, from tightly gated early studies to large multi-site and post-approval programs.
Protocol Execution Visibility
The trial execution problem
Complex protocols demand one operating system, not another tracker
From tightly gated early studies to large multi-site and post-approval programs, execution hinges on cohort and visit timing, safety gates, native capture, and treatment readiness. When those controls live outside an executable protocol, sponsors and CROs spend the study reconstructing status instead of running it.
Cohorts and gates live outside the protocol
Progression rules, observation windows, and cohort sequencing are tracked in spreadsheets and status calls instead of the executable model that defines them.
Sites and subjects progress in parallel silos
Visit readiness, treatment windows, capture, and subject status are reconciled by hand across disconnected tools and operational trackers.
Safety decisions lack a shared operating picture
Sponsors, medical monitors, and CROs assemble progression readiness from partial reports, often after the window to act has narrowed.
Execution is fragmented across point tools
Workflows, forms, treatment, inventory, and oversight are split across systems that never shared one protocol-native operating model.
Protocol-native operating system
Make the protocol the executable operating model
ProtoCore is a protocol-native clinical trial operating system for complex studies at any phase. It owns study configuration, workflows, native capture, treatment coordination, and sponsor oversight inside one governed environment.
Configure the protocol natively
Cohorts, visit schedules, eligibility, procedures, safety gates, and treatment readiness are configured once as the governed source of study design.
Compile into study, site, and subject workflows
ProtoCore turns that model into executable workflows, tasks, forms, dependencies, and progression rules tied to the protocol version in force.
Capture and coordinate inside one OS
Forms, ePRO/eCOA, eConsent, safety events, randomization, treatment, and inventory run as native capabilities, not as a patchwork of operational platforms.
Keep oversight connected to the protocol
Deviations, safety-review status, and progression decisions stay linked to the requirements that produced them, so visibility is an outcome of execution.
Run any phase from a shared operating picture
ProtoCore runs protocol requirements, native capture, treatment coordination, and sponsor visibility in one operating environment, so cohorts, safety gates, and site activity stay aligned across three sites or three hundred, without asking every stakeholder to maintain a private tracker.
Coordinate what the protocol requires
Cohort sequencing, observation windows, visit and treatment timing, and safety gates stay connected to the protocol model, so execution status is not reconstructed after the fact.
Give sponsors and CROs the same view
Site readiness, subject progression, deviations, and the next progression decision appear in one operating picture shared across accountable roles.
Surface exceptions while they still matter
Pharmacy holds, window misses, and pending safety review show up as operating signals, not buried in the next weekly status deck.
All Studies
ACME-1042 Multi-Site Study
ActiveACME-1042·Created Jan 12, 2026
ACME-1042 Multi-Site Study
ACME-1042ActiveRandomized, multi-site study. Cohort C3 in treatment; C4 gated on safety review and site readiness.
Protocol
ACME-1042 v2.1
KPI summary
Health 72 · WatchEnrollment progress
Enrollment trendcumulative · per week
The study in view
An operating picture built for execution reality
An illustrative multi-site study overview in the same layout sponsors and CROs use in ProtoCore: KPI summary, enrollment, sites, safety and operations backlog, needs-attention items, and the next cohort milestone.
All Studies
ACME-1042 Multi-Site Study
ActiveACME-1042·Created Jan 12, 2026
ACME-1042 Multi-Site Study
ACME-1042ActiveRandomized, multi-site study. Cohort C3 in treatment; C4 gated on safety review and site readiness.
Protocol
ACME-1042 v2.1
KPI summary
Health 72 · WatchEnrollment progress
Enrollment trendcumulative · per week
Site performance12/14 active
Safety & operations backlog
Safety
2
Patients on safety hold
2 pending review · committee open
Operations
9
Overdue tasks
Oldest 4d · 12 due soon
Needs attention
Safety review required before C4 opens
Progression gate · packet in review
Site 04 pharmacy hold blocking treatment
Accountability check outstanding
Visit window miss logged for SUBJ-1012
Major deviation · under review
Milestones
First subject enrolled
Achieved Apr 3
Open Cohort C4
Target Aug 8
C3 visit window close
At risk · 36h
Recent activity
Observation window closed for C3
1d ago · patient-engine · by a.kim@acme.test
Safety review packet published for committee
1d ago · study-engine · by m.rao@acme.test
Protocol deviation logged · visit window
6h ago · patient-engine · Site 04
One operating model
One operating model, even when specialized services remain external
ProtoCore natively manages protocol-driven execution and data capture. When a study requires central labs, imaging, devices, or logistics providers, their data enters the appropriate study context without fragmenting the core operating model.
Native in ProtoCore
- Protocol configuration
- Study, site, and subject workflows
- Forms and clinical data capture
- ePRO / eCOA and eConsent
- Safety and adverse-event capture
- Randomization and treatment management
- Inventory and accountability
- Operational oversight and audit history
Specialized services that may stay external
Inherently specialized providers, and necessary sponsor legacy feeds, integrate through governed connections. Their data lands in ProtoCore study context; the core operating model stays intact.
Sponsor & CRO outcomes
Built for the teams accountable for trial delivery
ProtoCore helps sponsors and CROs run complex protocols at any phase from one governed operating environment, reducing fragmentation between configuration, capture, treatment, and oversight.
Fewer handoffs around cohort decisions
Progression gates, cohort status, and treatment readiness stay in one executable model instead of scattered trackers and status calls.
Sponsor and CRO oversight from execution
Study, site, and subject status reflect native operating state, not a deck assembled after the fact.
Native capture, treatment, and inventory
Forms, ePRO/eCOA, eConsent, safety events, randomization, treatment, and accountability run inside ProtoCore, not across a patchwork of operational platforms.
Trace activity back to the protocol
Tasks, progression, and exceptions remain tied to the protocol version and requirements that produced them.
Controlled change with attributable history
Versioning, access control, and append-only audit records support inspections and reconstruction of what happened when.
Role-scoped work for the people running the trial
Investigators, coordinators, medical monitors, and operations teams see what their role permits, on the same study model.
Controlled operations & traceability
Controls that support accountable clinical operations
ProtoCore includes practical controls for access, versioning, and attributable history. Claims below reflect capabilities in the product, not certifications or guaranteed regulatory outcomes.
Role- and context-based access
Users are scoped to the studies, sites, and data their role permits, with access checks enforced on requests.
Attributable history
Actions can be recorded with actor, timestamp, and before/after state in append-only audit records for later reconstruction.
Versioned protocols and controlled publishing
Protocol versions are published under governance so execution can follow the version in force, with a history of what changed.
Enterprise sign-in controls
Supports enterprise identity patterns such as SSO-ready authentication, with session controls appropriate for clinical environments.
Encryption for sensitive data
Sensitive data is protected with encryption in transit and at rest, with minimization practices in logs and notifications.
ProtoCore Studio
Explore trial data when execution needs a workbench
Studio is secondary to the execution story. When teams need to inspect and work with connected trial data, ProtoCore Studio provides a governed catalog, read-only query, and versioned pipeline surface, kept in service of protocol-driven operations.
Dataset catalog
Discover study-scoped datasets available for governed exploration.
Read-only SQL workbench
Query approved schemas within a safety envelope: timeouts, SELECT-only access, and row limits.
Versioned pipelines & lineage
Define outcome-oriented pipelines, publish immutable versions, and inspect column-level lineage.
Structured outputs
Generate structured trial outputs such as SDTM- and ADaM-oriented datasets where configured, not a claim that every CDISC domain is covered out of the box.
Founding Partner evaluation
Evaluate ProtoCore on your protocol, then deploy on a bounded study
We selectively partner with sponsors and CROs to prove ProtoCore on real operating needs, whatever phase the program is in. Adoption risk is reduced through a controlled path, not by running permanently in parallel with an incumbent clinical platform.
Adoption path
- Completed-protocol evaluation
- Synthetic simulation
- Qualification and UAT
- Deployment on a new, bounded study
Completed or de-identified protocol
Work from a real completed or de-identified protocol so evaluation reflects operational complexity, not a toy demo.
Synthetic data and simulated execution
Exercise cohort progression, gates, capture, and site activity with synthetic data and simulated runs.
Protocol-to-workflow traceability
See how protocol requirements compile into workflows, tasks, and progression rules.
Configuration and manual-handoff measurement
Measure configuration effort and where manual handoffs remain, so the evaluation is grounded.
Cohort, site, and exception visibility
Review the shared operating picture for cohorts, site readiness, and exceptions.
Audit-history reconstruction
Walk attributable history to reconstruct what changed, when, and by whom.
Explicitly out of scope for evaluation
No active-study migration. No permanent parallel operation with an incumbent EDC. Evaluation uses completed or de-identified protocols, synthetic data, and simulated execution ahead of deployment on a new, bounded study.
See ProtoCore run a complex protocol
Walk through protocol configuration, native capture, cohort and safety-gate execution, treatment coordination, and sponsor oversight inside one governed operating environment, at whatever phase your study is in.