Run clinical trials from the protocol outward.
ProtoCore transforms the study protocol into a living operational system that drives execution, data collection, and trial visibility from start to finish.
The problem
Trials run on a protocol. Trial systems don't.
Once a study starts, the protocol and its execution drift apart. Capture is split across vendors and point systems, oversight is assembled after the fact, and the data the trial exists to produce is the last thing to become available.
The protocol gets disconnected
The protocol is approved, then re-implemented by hand across EDC builds, site instructions, and trackers, drifting from the document that defines the study.
Data lives everywhere
EDCs, central labs, imaging vendors, logistics systems, site files, and spreadsheets each hold a slice of the trial, and rarely agree at the row level.
No unified visibility
Sponsors and CROs assemble study status from periodic reports and vendor portals instead of one connected view of execution.
Data availability lags
Analysis-ready data arrives only after reconciliation cycles, so teams operate reactively, and database lock becomes a fire drill.
The platform concept
The protocol is the operating layer
ProtoCore is not another portal layered on top of the trial. It is the system the trial runs on, where the protocol drives workflow, capture, visibility, and downstream data availability.
The protocol defines the study
Endpoints, eligibility, visit schedule, and procedures are configured once as the governed source of the study design.
The platform turns it into workflows
ProtoCore compiles the protocol into executable workflows, with no parallel re-implementation in disconnected systems.
Workflows drive execution
Visits, tasks, forms, rules, and capture run from the protocol model, for every site and every patient.
Data becomes available
Everything captured flows into operational views, audit trails, and downstream datasets, connected back to the protocol that produced it.
Data capture modes
Unify Trial Data Without Replacing Every Vendor
Most studies rely on a mix of EDCs, central labs, imaging providers, ePRO platforms, and operational systems. ProtoCore gives sponsors a single protocol-driven study model while allowing each data source to remain where it makes the most sense.
Native Capture
Collect data directly in ProtoCore through built-in forms, patient workflows, and site operations.
- eCRFs and study forms
- Patient diaries and tasks
- Site workflows and execution
Captured in ProtoCore
External Capture
Bring structured data from existing clinical systems into the same study model.
- Vendor-provided datasets
- Laboratory results
- Imaging and operational data
Received into the trial model
Hybrid Capture
Use ProtoCore where it adds value and external systems where they remain necessary.
- Per-domain capture strategy
- Unified study visibility
- One protocol model across all data
Right source, per domain
Sponsors see one study. Not a collection of disconnected systems. ProtoCore keeps protocol execution, operational workflows, and study data aligned regardless of where information originates.
Trial visibility, created by connected execution
ProtoCore is not a dashboard bolted onto your systems. Because the protocol, workflows, and capture run in one place, the state of the trial is always current and always inspectable, across operations and data alike.
Visibility from execution, not extracts
Because workflows and capture run on the protocol model, study status is a property of the system, not a report someone assembles afterwards.
Signals while they're actionable
Enrollment pace, overdue tasks, capture gaps, and safety items surface as risk signals while there is still time to intervene.
Routed to the accountable role
Material events, such as a serious adverse event or a slipping milestone, escalate to the roles responsible for them, with the audit trail to match.
← All Studies
PRC-204 · Created Jan 2026
KPI summary
Health 78 · WatchEnrollment progress
Enrollment trendcumulative · per week
Data available on demand, not after reconciliation
The trial exists to produce credible, traceable evidence. Whether a data point was captured natively or received from a vendor, ProtoCore keeps it clean, conformant, and continuously available, so interim analyses, DSMB reviews, and database lock are a controlled step, not an end-of-study project.
A single source of truth
Visits, source data, lab and imaging results, deviations, and documents resolve to one connected record per subject, not reconciled across disconnected systems.
An attributable audit trail
Every create, update, and status change is captured with actor, timestamp, and before/after state: the contemporaneous record 21 CFR Part 11 expects.
CDISC-conformant datasets
Generate SDTM, CDASH, ADaM, and raw extracts on demand, with conformance checks run before hand-off to biostatistics or the agency.
Export on your schedule
Pull analysis- and submission-ready extracts for DSMB reviews, interim analyses, or transfer to a sponsor or CRO, without a database-lock fire drill.
Encrypted in transit and at rest, scoped by least-privilege access, and fully audited at every step.
Product pillars
One Protocol. One Platform. Complete Trial Execution.
Everything ProtoCore does serves the same model: the protocol drives execution, and execution produces available, traceable data.
Protocol-Centered Study Design
Configure endpoints, eligibility, visit schedules, and procedures once, versioned and published as the governed source of the study.
Site & Patient Workflow Execution
Visits, tasks, eligibility, and safety workflows run directly from the protocol, for every site and every patient.
On-Demand Trial Visibility
Study, site, patient, and data status are always current, created by connected execution, not periodic reporting.
Flexible Data Capture
Capture data on built-in forms, receive structured vendor feeds, or combine both per domain on one trial model.
Audit-Ready Traceability
Every change carries actor, timestamp, and before/after state in a contemporaneous, tamper-evident trail.
Standards-Based Data Engine
Generate CDISC SDTM, CDASH, ADaM, and raw extracts with conformance checks, ready for downstream teams.
How it works
From protocol to data, in four steps
Define the protocol
Endpoints, eligibility, visit schedule, and procedures, configured and version-controlled in ProtoCore.
Configure study workflows
The platform compiles the protocol into site, patient, and data workflows: visits, tasks, forms, and rules.
Capture data: natively, externally, or both
Built-in forms and task execution where ProtoCore owns capture; structured vendor feeds where it doesn't.
Monitor and access data on demand
Execution status, audit trails, and standardized datasets are continuously available, with no waiting on reporting cycles.
For sponsors & CROs
Built for the teams accountable for the trial
ProtoCore is infrastructure for clinical operations, designed for the organizations that own study delivery, vendor strategy, and data quality.
Reduce operational fragmentation
Replace the patchwork of trackers, portals, and manual handoffs with one connected trial model.
Improve study visibility
Portfolio, study, site, and patient status from connected execution, not assembled status decks.
Support flexible vendor strategies
Bring capture in-house where it makes sense, keep vendors where they're necessary, per study, per domain.
Connect capture to protocol execution
Every data point ties back to the visit, task, and protocol version that produced it.
Be ready for audit and downstream work
Attributable trails and standardized outputs mean inspections and analyses start from order, not archaeology.
Move faster without losing control
Controlled workflows and versioned protocols let teams accelerate setup and execution inside guardrails.
Investigators, coordinators, and data managers work in the same system, each scoped to exactly what their role permits.
Trust & enterprise readiness
Built for controlled clinical operations
Clinical data carries some of the strictest regulatory and privacy obligations there are. ProtoCore is engineered for traceability, access control, and data integrity from the ground up.
Role- and context-based access
Every user is scoped to the precise studies, sites, and data their role permits: least-privilege, enforced on every request.
Attributable audit trail
Every action is recorded with actor, timestamp, and before/after state in a tamper-evident, contemporaneous trail aligned to ALCOA+ principles.
Controlled workflows & records
Versioned protocols, governed publishing, and regulated retention. Records are archived, never silently deleted.
Enterprise sign-in, SSO-ready
Single sign-on via enterprise identity providers, with MFA, session controls, and idle timeout for clinical environments.
Protected by design
ePHI is encrypted in transit and at rest, minimized in logs and notifications, and supported by HIPAA-conscious technical safeguards.
Part 11-aligned by design
Controlled records, attributable changes, and signature-ready workflows support 21 CFR Part 11 and Annex 11 expectations.
Bring protocol, workflow, and trial data into one operating layer
See how ProtoCore runs a study from the protocol outward, with native, external, and hybrid capture, and data available on demand.