What We Offer

Full site ownership.
From the first site selected to the last document filed.

Clinrova's Clinical Operations Lead manages every phase of your trial's site lifecycle — not as a monitor handed a running study, but as the same senior professional who evaluated the site before it was selected.

Design Partner Program

A different way to start.

Clinrova is currently working with a small number of rare disease sponsors as design partners. Design partners receive dedicated COL assignment, full AI platform access, and partnership pricing in exchange for integration access and co-development participation. If you have a Phase 2 rare disease study in the next 12 months, this is where the conversation starts.

Learn About Design Partnership
The Full Lifecycle

Comprehensive oversight
at every stage.

Our COL model ensures that the person who selects your sites is the same person managing them through close-out. There are no handoffs, no knowledge gaps, and no moment where accountability is unclear. Every phase of your trial is owned — not just monitored.

01
Site Feasibility and Start-Up
Setting the foundation right.
  • Site identification & qualification visits
  • Budget negotiation & contract execution
  • Regulatory document collection
  • IRB/EC submission support
  • System access provisioning
  • The COL assigned to your site at feasibility is the same person who closes it out. This is not a handoff model.
02
Site Activation
Ready to enroll. On time.
  • Investigator meeting coordination
  • Site initiation visits
  • Protocol training & assessment
  • Essential document readiness
  • First patient enrollment readiness
03
Study Conduct
Intelligence-driven monitoring.
  • Risk-based on-site & remote monitoring
  • Real-time data review & query resolution
  • Vendor oversight & issue escalation
  • Safety event facilitation
  • Enrollment performance tracking
  • Visit triggers are generated by the AI platform's real-time risk scores, not a monitoring calendar. The COL acts on evidence, not schedule.
04
Close-Out
Clean data. Clean exit.
  • Final data & TMF reconciliation
  • Site close-out visits
  • Regulatory document archiving
  • Final payment resolution
  • Lessons learned documentation
Who We Work With

Who we work with.

Clinrova is built for small-to-mid-size biotech running rare disease Phase 2 programs. Specifically: sponsors who have run a study with a large CRO, experienced the monitoring quality and cost predictability problems that come with it, and are ready for a different approach.

We also work with mid-size pharma sponsors who want the accountability of a boutique firm without sacrificing platform capability.

We are not the right fit for every study. If your program is outside rare disease Phase 2, contact us and we will tell you honestly whether we can serve it well.

Where We Focus

Where we focus.

Our primary focus is rare disease Phase 2. This is not a limitation — it is a deliberate choice that makes us better at it. Concentrated therapeutic area expertise, COL relationships with the investigator networks that matter most in rare disease, and an AI platform trained on the protocols and site behaviors specific to this space produce better outcomes than a generalist approach.

Phase I, Phase III, and medical device studies are evaluated on a case-by-case basis. Contact us to discuss fit.

The Engagement Process

From first conversation to
site-ready in four weeks.

We don't believe in drawn-out sales cycles or generic proposals. Our engagement process is fast, transparent, and built around your specific protocol — not a template.

1
Week 1
Discovery
We review your protocol, timelines, and current challenges to determine fit and begin scoping your monitoring plan.
2
Week 2
Custom Proposal
We deliver a fixed per-site pricing model based on your specific study complexity, risk profile, and site count.
3
Week 3
Contracting
We finalize the MSA and Work Order. No hidden fees, no travel pass-throughs, no surprises buried in the fine print.
4
Week 4
Kickoff
Your dedicated COL is assigned, the AI monitoring dashboard is configured for your protocol, and site management begins.
What to expect
Your first 30 days with Clinrova
COL assignment & introduction
Your dedicated Clinical Operations Lead is selected based on therapeutic area fit and relationship compatibility — not geography.
Dashboard configured to your protocol
The AI monitoring platform is set up with your protocol-specific risk parameters, data sources, and alert thresholds before the first site is activated.
Monitoring plan finalized
A site-specific monitoring plan is developed for each site based on its individual risk profile — not a single plan applied uniformly across all sites.
Site feasibility begins
Your COL begins site identification and qualification outreach, with regular sponsor updates built into the process from day one.
Sponsor alignment meeting
We define what success looks like for your team — not just study completion, but publications, presentations, regulatory milestones, and beyond.

Tell us about
your study.

We'll review it, tell you whether it's a fit, and provide a specific fixed-fee proposal with a named COL before you sign anything.

Work With Us