OKILYS suite · Clinical trial management
OKILYS CTMS, the modular CTMS that brings all your study management together
A CTMS designed to be practical: the core of a classic CTMS, plus all the follow-ups that usually live on the side — Excel trackers, call tables, training records, team management and allocation, a register of the system accesses each study requires. Everything is interconnected: information entered once shows up everywhere. Less paperwork, more time for the project, the patients, safety.
A 30-minute demonstration on your own use cases · Client access: ctms.okilys.com ↗
What OKILYS CTMS has that others don't
Everything in one place
The classic CTMS plus all the side follow-ups — CRA trackers, call tables, training, team allocation, system accesses, documents. One login, one source of truth.
Interconnected end to end
A date entered once feeds the site record, the follow-ups, the checklists and the dashboards. Nothing left to update in several places.
Easy to pick up
Clear navigation, built-in user guide per profile, Excel exports in the format your teams already know. English interface, usable on mobile. No heavy roll-out, no three-day training.
Less mental load
The traceability clinical research requires — audit trail, versions, signatures — happens in the background. Your attention stays on the study, its patients and safety.
Truly modular
A core, modules, tools
You only switch on what your study needs — and everything is interconnected.
The core, always included
Personal workspace, study overview, site records, predefined dashboards and exports, team, study profile. Ready to use from day one.
The modules, at your study's pace
From feasibility to close-out: site selection, visits with electronically signed reports, follow-up actions, submissions, contract & budget, documents & training. On top of these, thematic modules follow the study over its whole duration, such as sponsor oversight under ICH E6(R3): signed oversight plan, critical-to-quality factors and risks, KRI / QTL indicators computed live, co-monitoring visits, findings and CAPA, oversight reports. Each module adds its pages and registers, all connected to each other.
The tools, on demand
Greenlight, automated report check, Q&A log, fully customisable dashboards and extracts, planning & resources, call follow-ups, system access register. Usable on their own, even more useful plugged into the modules.
A core ready on day one, modules added as the study progresses — no migration, no double entry. Let's talk about your study →
Overview
The study at a glance, for the project manager and the CRA alike
The Overview page compares the study objectives (sites to activate, patients to screen and enrol, FSA / FPI / LPI / LPO / DBL milestones) with the actuals: start-up funnel, recruitment actual vs target and vs plan, visits of the next 30 days and pending reports, open actions by level, team and training, current documents, study news. Every tile opens the detail.
- Objectives and milestones set in the study profile
- Cumulative recruitment, actual vs plan
- Alerts: late visits, reports to review, overdue actions
- News published automatically (amendment, new version)
Workspace
Your tasks for the day, across all your studies
The home page is your workspace: for every study you work on, it gathers the pending tasks and reminders that concern you, according to your role (visits, reports, actions, requests awaiting your validation). A summary per study first, then the task cards, and a button to pick up where you left off.
- Tasks and reminders grouped by study, filtered by your role
- Notification counter for what is waiting for your validation
- One click back into the last study you opened
- Study search by code, name or client
Roles and permissions
One global model, customisable study by study
Admin, project manager (CTM / CPL), report reviewer, CRA, viewer: each profile sees and edits what concerns it, the CRA only their countries. The global permission model is adjusted by a study administrator to fit each type of study. Access periods per account and per study, cascading revocation.
- The same person can be CTM on one study and CRA on another
- Access for CRAs as well as for the sponsor's CPLs
Security and compliance, by design
Access
Named accounts, mandatory two-factor authentication, lock-out after failed attempts, limited sessions, immediate revocation.
Electronic signatures
Reports and greenlights finalised by traced, tamper-evident electronic signature: re-authentication, content fingerprint, time stamp, verifiable manifest.
Audit trail
Every creation, change, closure, download and signature is logged (who, when, before / after). Soft deletion with a trash.
Confidentiality
Your data serves your study and nothing else. Nothing is sent to a third-party service; hosted in France; privacy notice and terms accepted and traced.
How it works
Scoping
A 30-minute call to choose the modules and the templates (yours or OKILYS').
Set-up
Creation of your space, study, countries and accesses; import of your existing action and CRA follow-up trackers.
Onboarding
Built-in user guide per profile, CRA onboarding, adjustment of templates and action rules.
Operations
Nightly backups, data packages, evolutions driven by your feedback.
The offer: subscription per study, per pack or per module; the number of planned sites is set in the contract. The standalone tools can be subscribed alone. Pricing and conditions on quotation.
OKILYS CTMS is designed from the field, for field teams, and developed by 
INFRARCHNetwork, Security & Automation (La Vieille-Loye, France).