Twelve modules. One platform.
Every capability you need to run a hybrid or decentralized trial — built natively on a single data model, secured by design, and configurable in hours.
Pick what you need. Use it together.
No-Code Study Builder
Configure protocols, visits, and forms without programming. Drag-and-drop with conditional logic and edit checks.
Schedule of Visits
Calendar-view schedule of assessments. Window math, dependencies, and amendments versioned automatically.
Visit Form Builder
30+ field types, validations, derivations, repeating sections, and library forms reusable across studies.
e-Consent
Multi-language electronic informed consent with comprehension checks and signed PDF audit trail.
e-Enrollment
Self-service enrollment with AI eligibility matching and investigator approval workflows.
Notifications & Alerts
Visit reminders, missed-visit escalations, AE/SAE alerts, and emergency broadcasts to roles or cohorts.
Web Call & Chat
Encrypted video and chat between subjects, investigators, and CRAs — fully audited.
Lab Visit Scheduler
Subjects choose at-home or on-site visits. Sites and labs receive readiness notifications.
IoT & Wearables
Connect smart watches and medical devices to push vitals into visit forms in real time.
Behavior Monitoring
ML signals on engagement, adherence, and risk of drop-off — actioned by site staff.
ProCoins Compensation
Milestone-based subject compensation that drives retention without manual reconciliation.
Blinded eCRF
Sponsors and CRAs see clean data with subject identity protected at the source.
Built for scale, speed, and audit.
ProCTTH is a single platform — not a stitched-together suite. That means one identity, one audit trail, one upgrade path.
Unified data model
Subjects, visits, forms, devices, and audit events live in one schema — no per-study silos.
Real-time pipeline
Stream-first ingestion. Data captured at the bedside is queryable in under a second.
Edge-first AI
Eligibility matching, anomaly detection, and form auto-generation run inside the platform.
Versioned everything
Protocol amendments, form revisions, edit checks, and consent versions are all branch-able.
Built on profiles, not silos.
ProCTTH organizes everything around users and their roles — granular, auditable, and aligned with how research teams actually work.
Machine learning that earns its place.
We use AI where it measurably reduces operational burden — never as marketing decoration.
- Protocol → form auto-generation with reviewer-in-the-loop
- Eligibility matching across subject profiles and EHR data
- Drop-off prediction from engagement signals
- Anomaly detection on captured vitals and lab values
- Auto-translation for multi-region studies
From bedside to database lock.
A single pipeline moves data from capture to analysis. No batch exports, no nightly ETL, no brittle integrations between vendors.
Capture
Site enters source data once. IoT devices push vitals. Subjects submit ePRO in-app.
Validate
Edit checks, range validations, and cross-form rules fire as data lands.
Monitor
CRAs review queries, flag deviations, and sign off remotely or on-site.
Lock & export
Database lock in days. CDISC-ready exports for SAS, BI, or downstream pipelines.
Plays well with your existing stack.
Open APIs, webhooks, and pre-built connectors keep ProCTTH in sync with your CTMS, EHR, labs, safety systems, and analytics.
CTMS connectors
Veeva, Medidata, and custom CTMS sync for sites and sponsors.
Central labs
HL7 and FHIR feeds from LabCorp, Quest, and regional labs.
Wearables & IoT
Apple HealthKit, Fitbit, Withings, and Bluetooth medical devices.
Safety systems
AE/SAE push to Argus, ArisGlobal, or a custom safety endpoint.
BI & analytics
CDISC SDTM exports, S3 sync, Snowflake, and BigQuery destinations.
SSO & identity
SAML 2.0, OIDC, Okta, Azure AD, and SCIM provisioning.
Audit-ready from day one.
- 21 CFR Part 11 — e-signatures & audit trail
- ICH GCP E6 (R2) aligned workflows
- HIPAA — BAA available on request
- GDPR + regional data residency controls
- SOC 2 Type II & ISO 27001 reports
- Validation pack: IQ / OQ / PQ on request
Global, regional, or single-tenant.
- Multi-regionPin studies to EU, US, India, Japan, or Canada.
- Single-tenant optionIsolated instance for enterprise sponsors.
- 99.95% uptime SLAActive-active infrastructure with automated failover.
- Encryption everywhereTLS 1.3 in transit, AES-256 at rest, field-level encryption for PII.
Common questions.
Most studies activate in 2–4 weeks, including protocol configuration, form library reuse, and site training.
Yes — we offer mid-study migration for EDC, eConsent, and ePRO replacements, including historic data import with audit trail preservation.
No. Identity lives at the site. Sponsors and CROs work with blinded subject IDs across all modules.
Yes — study designers can enable paper-to-source workflows for specific sites or regions when required by IRB/EC.
Absolutely. Import CDASH/CDISC-aligned forms or build from scratch with the no-code builder. Forms are reusable across studies.
Data is frozen, a CDISC SDTM export is generated, and the full audit trail is preserved for retention windows you configure.
A platform built for the next decade of trials.
Book a 30-minute walkthrough with our clinical operations team and see ProCTTH configured for your protocol.