Platform · How it works
From source evidence to informed monitoring decisions.
Loopa checks the source data you provide against study requirements and across documents. Potential issues become Loops with supporting evidence for monitor assessment. EDC Verification compares source information with EDC data through an available read-only connection.
In short
- How it arrives
- Source documents uploaded directly to Loopa or through an available connection.
- What is read
- The source data you provide, including supported handwritten documents.
- Read against
- The requirements established for your study’s review scope.
- Human review
- Monitors assess potential issues and determine the next step.
- You receive
- Loops with supporting evidence and recorded review decisions.
- Site and EDC
- Document submission through the agreed workflow. EDC connections are read-only where available.
Platform walkthrough · Narrated
Four steps, shown on the product.
Product screens show synthetic study data. Numbered markers match the notes beside each screen.
Step 01 of 04
Requirements Intelligence.
Loopa structures requirements from the study documents in scope and links them to their source text. A monitor reviews and accepts the requirements baseline.
On the screen
The sentence in the protocol that creates the obligation.
The requirement taken from that sentence, tagged by type and section and marked Accepted.
A second requirement from the same page, taken from the first item in the list.
Step 02 of 04
Source review, with evidence attached.
Loopa checks the source documents provided and opens potential issues as Loops beside the supporting evidence.
What is a Loop?
A Loop is a structured record of a potential issue requiring human assessment. It becomes a Finding only when a monitor confirms it.
On the screen
The page as the site completed it, by hand.
The field that triggered the Loop: the pregnancy test is marked N/A and no reason is given.
The Loop, raised beside that field with an illustrative model confidence score (88%) and the evidence as read from the page.
Step 03 of 04
Monitor assessment and decision.
Each Loop presents the potential issue, relevant requirement, and suggested action. A monitor assesses the evidence and records a disposition: confirm, override, observation, or close. A confirmed Loop becomes a Finding.
On the screen
The proposed severity and current status of the Loop: major, pending.
What was found, in plain words.
The requirement the page is measured against.
The recommended action: a query.
The four dispositions: Confirm, Override, Observation and Close.
Step 04 of 04
Findings carried through to closure.
This illustrative Finding shows triage, PI review, reporting, and CAPA follow-up. Completed steps show who acted and when.
On the screen
Triage: type, importance, whether a CAPA is required, and whether it is reportable.
Each completed step shows who completed it and when.
In this example, closure remains gated while the required CAPA follow-up is incomplete.
Source review starts with the study’s requirements.
Requirements Intelligence
Requirements Intelligence is the framework for organizing what applies to a study. The requirements used for platform review are established for the agreed scope and reviewed by a monitor.
01
Study requirements
Protocols, amendments, consent documents, laboratory manuals, and other study-specific documentation.
02
Operational requirements
SOPs, monitoring plans, sponsor procedures, and study-specific working instructions.
03
Governing requirements
Applicable regulations, GCP standards, and regulatory guidance, considered in the context of the study.
In practice: six examples of what Loopa checks
Visit windows
Compare recorded visit dates with protocol windows and the study event sequence.
Eligibility
Compare documented criteria with the current protocol and flag missing supporting evidence.
Lab values against protocol ranges
Compare recorded values and units with protocol thresholds and related records.
PI and delegated signatures
Cross-reference signatures with the delegation log and identify missing signatures.
Informed consent review
Review the recorded consent evidence, signatures and dates against study requirements.
Source-to-EDC verification
Compare source information with EDC data through an available read-only connection. Monitors assess differences.
Shared responsibility
Who does what, at each step.
The table shows Loopa-led monitoring. With platform licensing, the sponsor’s or CRO’s monitors perform the human review and follow-up.
Responsibilities, access, and escalation arrangements are defined for the study. The platform supports review; it does not make clinical judgments or independently determine compliance.
What you receive
What reaches you, and when.
For review
Loops
Potential issues presented with supporting evidence for monitor assessment.
After monitor confirmation
Findings
Confirmed issues with the recorded assessment and supporting evidence.
Agreed for your study
Reporting
Reporting scope, format, and review cadence are agreed for the engagement.
Agreed scope
Export requirements
Confirm the records and export formats needed for your study.
For your buying group
What each part of your team needs to know.
Quality and regulatory
Trace requirements to source evidence.Review documented monitor decisions.Confirm workflow controls for the intended use.
Security and data
IT and security
Confirm supported connections and access.Review data handling and security documentation.EDC connections are read-only where available.
Security and data
Clinical operations
Review the source data provided.Assess Loops before and between visits.Agree site submission and follow-up workflows.
For sponsors
Procurement
Loopa-led monitoring with scope agreed per study.Platform licensing for sponsor and CRO monitoring teams.
Request a demo
Limits, stated plainly
Scope and boundaries.
Source coverage
Review depends on the source data provided and supported input types.
Human judgment
Monitors assess potential issues and decide what action is appropriate.
EDC access
Available EDC connections are read-only.
Requirements scope
The requirements used for review are established for the study.
Data handling
Review security and data-handling documentation during evaluation.
Connections and availability
Confirm supported connections and current functionality for your study.