Loopa OS, A Private Preview for CRO Partners

The monitoring operating system for modern CROs.

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.

Three forces are converging that change what sponsors expect from their monitoring partners.

Source document: patient visit record Visit 4 of 12
Vital signs
Concomitant medications
Adverse events
Investigator signature
Study drug accountability
Traditional SDV reviews one section. The rest is a blind spot. Loopa OS scans the entire document. Every field. Every visit.
Hover over the document Tap the document
0%
of trial budget goes to monitoring
NCBI, National Academies
0%
of CRA time on-site and traveling
Tufts CSDD
0%
of CRF data changes detected by SDV
TransCelerate

Introducing Loopa OS.

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.

Loopa
OS
Protocol GCP ALCOA+
Paper eSource eReg
Critical Major Minor
Findings CRA Review
Audit CAPA Closure
01
Compliance foundation loaded
The study protocol, GCP guidelines, ALCOA+ principles, FDA regulations, and sponsor SOPs are ingested. This builds the compliance ruleset every document is evaluated against.
Protocol ICH E6(R3) ALCOA+ 21 CFR SOPs
02
Source documents flow in
Paper records, electronic source data, and regulatory binder documents enter the platform continuously. Every document is scored against the compliance ruleset.
Paper eSource eReg Loopa OS
03
Loopa scores and classifies
Deviations are classified by severity: Critical, Major, or Minor. Source data is reconciled against the EDC. Cross-system discrepancies are flagged automatically.
Critical Major Minor
EDC: Medidata RAVE, Oracle InForm
04
CRA reviews and decides
The monitor receives a prioritized queue of findings. They confirm, override, or escalate. Every action is logged with their identity and a documented rationale.
Findings CRA judgment Confirm · Override · Escalate
05
Loop closes, output ready
Findings resolve. CAPAs trigger when patterns emerge. A complete, inspection-ready compliance record is available at any time. New documents arrive and the cycle continues.
Audit-ready export CAPA triggers
Continuous. Every visit. Every site.

Loopa OS maps to the monitoring lifecycle your team already follows. It does not replace your process. It runs underneath it.

1
Study activation
Protocol ingested. Compliance ruleset built. Baseline set before first patient enrolled.
2
Continuous monitoring
Every visit scored. EDC reconciled. CRAs receive prioritized findings. Portfolio dashboards update in real time.
3
Issue management
Findings triaged by severity. CAPAs auto-trigger on recurrence. Full lifecycle managed inside the platform.
4
Reporting and close-out
Audit-ready exports on demand. Complete compliance history for every site, patient, and visit.

Your CRAs did not get into clinical research to chase paper.

They got in to protect patients and ensure data integrity. Loopa OS gives them the platform to do that work.

The Current Reality

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 Loopa OS Reality

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.

CRA time reallocation.

This is not about doing less. It is about redirecting time from low-value mechanical tasks to high-value clinical work.

Traditional monitoring
SDV, 46% Travel, 25% Admin, 15% Clinical, 14%
SDV and manual data comparison Travel and on-site logistics Administrative documentation Clinical oversight and site engagement
With Loopa OS
Clinical oversight, 40% Risk, 25% Relationships, 20% Triage, 15%
Clinical oversight and site engagement Risk assessment and escalation Site relationship management Platform review and triage

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.

Sponsors are evaluating CRO bids differently now.

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.

Data coverage
Traditional
Sampled SDV at selected sites per monitoring plan.
Loopa OS
100% patient visit coverage, every site, continuous.
Deviation detection
Traditional
CRA-identified during on-site visits.
Loopa OS
AI-powered, protocol-aware auto-detection with severity classification.
Real-time oversight
Traditional
Monitoring reports delivered after site visits.
Loopa OS
Real-time compliance dashboards with live finding status.
EDC reconciliation
Traditional
Manual CRF-to-source comparison during SDV.
Loopa OS
Automated source-to-EDC reconciliation via API, Medidata RAVE and Oracle InForm.
CAPA management
Traditional
Logged in eQMS after manual identification.
Loopa OS
Auto-triggered by pattern detection, full lifecycle inside the platform.
Audit readiness
Traditional
Weeks of preparation before inspections.
Loopa OS
One-click export, inspection-ready at any time.
Regulatory alignment
Traditional
GCP-trained CRAs following SOPs.
Loopa OS
Built-in R3 Section 3.9.3, Section 3.11.4.2, and ALCOA+ alignment.

The next RFP you respond to will ask about your technology. Loopa OS turns that question into your strongest differentiator.

Your team is your asset. Loopa OS does not reduce your team. It multiplies what your team can cover.

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.

8-10
sites monitored
Coverage limited by geography and travel capacity
~40 hrs
monthly travel

This is a throughput story, not a reduction story. The same team services a broader portfolio. Capacity grows without proportional headcount growth.

We built Loopa OS to pass the same inspections your sites face.

  • 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
  • Attributable: Every action logged with authenticated user identity. Full audit trail.
  • Legible: Human-readable records. Version-controlled display. Export fidelity.
  • Contemporaneous: Server-side UTC timestamps. No user-editable timestamps.
  • Original: Source documents preserved without modification. Checksum verification.
  • Accurate: Protocol-aware validation. Override-with-rationale workflow.
  • Complete: No permanent deletion. Gap-free audit trail.
  • Consistent: UTC normalization. Cross-source discrepancy detection.
  • Enduring: AWS multi-AZ. Documented backup and recovery.
  • Available: Role-based access. On-demand inspection exports. Tenant isolation.
  • Audit trails on all electronic records
  • Electronic signatures with attributable identity
  • Role-based access control across the platform
  • System validation per GAMP5
  • IQ/OQ/PQ protocol available on request

Loopa OS is not a vendor product you bolt on. It is the operating layer your monitoring workflow runs through.

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.

Let's talk about how Loopa OS fits your operation.
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Or email us directly at hello@loopalogic.com