Clinrova assigns a single Clinical Operations Lead to every site in your rare disease study — a senior professional with 10+ years of experience who owns every aspect of monitoring, paired with an AI platform that triggers visits by data, not by schedule. Fixed-fee pricing. No surprises.
A CRA is assigned to your sites. Fourteen months later, they're gone. A new one comes in, re-reads the protocol, re-introduces themselves to the PI, and the cycle starts over. Your study is being monitored on a calendar — not because a site needs a visit, but because the schedule says it's time. You're billed for the visit, the travel, and the time, whether the site had a single open query or forty.
Large CROs are not built to fix this. Their billing model depends on it.
One COL per site. AI-powered risk scoring. Fixed per-site pricing, no pass-throughs.
One senior professional owns your site from start to finish. Not a rotating CRA. Not a junior monitor managed by someone in a different time zone. A COL who knows your PI by name, understands your protocol's edge cases, and has accountability that doesn't reset when someone gets promoted.
Our platform aggregates real-time data from your EDC, TMF, CTMS, RTSM, and safety databases to generate continuous site risk scores. When a site needs a visit, the data says so. When it doesn't, the COL monitors remotely. Visits are triggered by evidence, not schedule.
One price, set at kickoff, per site. No time-and-materials billing. No travel pass-throughs. No change orders for things a competent monitoring company should have anticipated. You know what monitoring costs before the study starts.
The Clinical Research Associate model was designed for a different era. It fragments accountability across roles, creates handoff gaps, and generates costs that are impossible to predict.
We replaced it entirely. Our Clinical Operations Lead is a single, senior expert assigned to every site — someone who owns the full relationship from the first feasibility call to final close-out, supported by AI-driven centralized monitoring.
| Dimension | Traditional CRO | Clinrova |
|---|---|---|
| Monitoring role | CRA — monitoring only | COL — full site mgmt |
| Visit frequency | Calendar-based, every 4–8 wks | Risk-based, per site |
| Centralized monitoring | Often an afterthought | AI-powered, data-driven |
| Vendor issues | Routed through 2–3 people | COL handles directly |
| TMF readiness | Scramble at close-out | Ongoing from start-up |
| Pricing | T&M + travel | Fixed per-site fee |
| Site assignments | Geography-based | Relationship & fit-based |
Our platform draws on data across EDC, TMF, CTMS, RTSM, and safety databases to generate an up-to-date risk score for every site. Anomaly detection surfaces issues before they become deviations. Every on-site visit is triggered by data — not by a calendar.
Rare disease Phase 2 programs move on their own terms — small patient populations, concentrated investigator networks, high-stakes proof-of-concept data, and sponsors who cannot afford monitoring that misses what matters. Clinrova's Clinical Operations Leads are matched to the therapeutic areas and investigative ecosystems where your sites live. They know the PIs. They understand the regulatory context. They stay through close-out.
Clinrova is currently accepting design partner relationships with two to three rare disease sponsors. Design partners co-develop the monitoring model with us — providing feedback on platform performance, data integration access, and input on how fixed-fee pricing is structured for their therapeutic area — in exchange for a partnership pricing rate and early access to a monitoring model that does not exist anywhere else.
This is not a sales pitch. It is an invitation to build something together.
You know what your monitoring costs before the trial starts — and it doesn't change. No time-and-materials billing. No monthly travel surprises. One fixed fee per site, scoped to study complexity, locked at kickoff.