The operating system
for clinical trials
One AI-powered platform for every role in your trial — from site selection to regulatory submission. Built for GxP-regulated environments, compliant by design.
From first protocol to final submission.
ClinicalOS covers every phase of your trial lifecycle — no gaps, no handoff friction, one audit trail.
Prepare
Protocol design, site selection, investigator scoring, feasibility, regulatory submissions
Conduct
Patient recruitment, eConsent, EDC, monitoring visits, drug supply, lab kits
Oversee
Safety surveillance, DSMB, SUSAR reporting, risk-based monitoring, quality signals
Manage
Budgets, contracts, vendors, compensation, timelines, resource allocation
Closeout
CSR authoring, database lock, TMF archival, regulatory submissions, CTD publishing
Admin
User management, audit trail, compliance dashboards, SOPs, training records
16 roles, 6 domains.
Each role gets purpose-built tools for every trial phase — from study start-up to regulatory submission. All connected by shared data and AI.
Clinical Operations
Clinical Ops Director, Study Start-up, Portfolio Manager
Site selection, investigator scoring, enrollment tracking, study monitoring, budgets, and vendor management.
Regulatory & Quality
Regulatory Affairs, Quality Manager
eCTD submissions, regulatory watch, FDA 483 responses, inspection readiness, audit trail, and TMF management.
Safety & Pharmacovigilance
PV Officer, Medical Monitor
ICSR processing, SUSAR tracking, DSMB portal with data firewall, E2B(R3) export, and signal detection.
Data Management
Data Manager, SAS/R Programmer
Visual CRF designer, SDTM/ADaM mapping, edit checks, medical coding, and data quality dashboards.
Medical Writing & Biostats
Medical Writer, Biostatistician, Clinical Pharmacologist
CSR authoring (ICH E3), protocol design, consistency checks, statistical analyses, PK/PD modeling, and TLF generation.
Site & Field Operations
CRA/Monitor, PI/Investigator, CRC, Supply Chain Manager
Monitoring visits, delegation logs, eSource, SDV, drug accountability, cold chain tracking, and patient management.
ClinicalOS for your role
Select your role and discover how ClinicalOS transforms your daily work.
Connected to the data that matters.
Live integrations with global registries, literature databases, EDC systems, and our own AI engine.
Ready to run your trials differently?
See how ClinicalOS connects every role in your trial — from site selection to submission.