- Protocol compliance checking: Principle 8, Section 3.9.3
- Centralized monitoring as sole method: Section 3.11.4.2
- CtQ-driven severity classification: Principles 6 and 7
- Continuous risk detection for RBQM: Section 3.4
Loopa OS is the compliance intelligence layer that lets your team monitor every patient visit, across every site, continuously. Not a sample. Not a snapshot. Every visit.
Loopa OS is the compliance intelligence layer your monitoring operation runs on. It ingests source documents, scores them against the protocol, reconciles data against the EDC, classifies deviations by severity, and surfaces what needs human attention. Your CRAs stop chasing paper and start making clinical decisions.
They got in to protect patients and ensure data integrity. Loopa OS gives them the platform to do that work.
46% of on-site time is spent on source data verification alone. CRAs manually compare source documents against case report forms, flag discrepancies one by one, document findings in monitoring reports, and repeat the process at the next site. Travel days. Paper stacks. Manual reconciliation. The most skilled clinical professionals in your organization spending the majority of their time on tasks that do not require clinical judgment.
The system handles document intake, source-to-EDC comparison, and compliance triage before the CRA opens their dashboard. What the CRA sees is a prioritized list of findings that need human assessment: clinical context, site relationship decisions, investigator conversations, protocol adherence coaching, and risk escalation. The work shifts from data processing to clinical oversight.
This is not about doing less. It is about redirecting time from low-value mechanical tasks to high-value clinical work.
Every action the CRA takes inside the platform is logged with their authenticated identity and a UTC timestamp. When a CRA overrides an AI classification, the system requires a documented rationale, preserving both the original AI assessment and the human judgment.
The weight is shifting from how many CRAs you can deploy to what your monitoring technology stack looks like. Loopa OS is the answer to that question.
The next RFP you respond to will ask about your technology. Loopa OS turns that question into your strongest differentiator.
A CRA conducting traditional SDV-heavy monitoring is constrained by the physics of the job: travel time, on-site hours, manual document review, report writing. There is a ceiling on how many sites and patients one monitor can effectively cover.
Loopa OS removes the mechanical bottleneck. Continuous AI-powered compliance screening handles the intake, comparison, and triage. The CRA focuses on the findings that require clinical judgment, site engagement, and risk escalation. The result: more sites covered per CRA, more studies serviceable per team, and better margins on fixed-fee and per-site contracts.
This is a throughput story, not a reduction story. The same team services a broader portfolio. Capacity grows without proportional headcount growth.
We work with your operations team to configure the platform for your SOPs, train your monitors, and integrate with your existing systems. Onboarding starts with your protocols.
For CROs that want to present a unified technology offering to sponsors: deploy Loopa OS as part of your proprietary monitoring stack. Your brand, your client relationship, our engine underneath.