Clinical expertise,amplified by intelligence.
Loopa delivers clinical monitoring with our own clinical monitors and our proprietary platform. The platform checks the source data you provide against study requirements and across sources. Our monitors assess potential issues, document their decisions, and follow up with sites within the agreed monitoring scope.
Discuss monitoring for your studyTwo components. One operating model.
The platform brings requirements and source evidence together for review. Our monitors bring clinical context, assess potential issues, and determine the next step.
They assess each Loop in its clinical and study context, document their reasoning and decision, and follow up with the site as agreed for the study. Each decision is recorded with who made it and when.
Requirements Intelligence maps the study and operational requirements that apply to each study. Loops compare the source data you provide against those requirements and across documents, and surface potential issues for review. EDC Verification compares source information with the EDC, read-only. The platform proposes; it does not decide.
Where the platform checks, and where the monitor decides.
The four stages, on any study.
A Loop is a question; it becomes a Finding only when a monitor confirms it. The investigator’s responsibility to assess and report safety events remains unchanged. The platform doesn’t determine compliance. It provides the intelligence and evidence to assess it.
How it works-
01 · Requirements Intelligence
Establish the study’s requirements for review.
A monitor reviews and accepts them.
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02 · Evidence verification
Check the source data you provide against those requirements and across documents.
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03 · Loops and human assessment
Surface potential issues with their supporting evidence.
A monitor assesses the context, records a decision, and follows up as needed.
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04 · EDC Verification
Compare source information with EDC data, read-only, where a connection is available.
Monitors assess any differences.
“A monitoring visit should begin with a prepared CRA and a clear view of the questions that need attention. That is what we are building Loopa around: a platform that brings source evidence together, and clinical monitors who assess it, apply their judgment, and follow up with the site. With Loopa-led monitoring, we bring both to the study and take responsibility for the work we agree to deliver.”
Quality first.Velocity built in.
Quality is the reason to work this way. The platform prepares the evidence. Monitors apply their judgment.
Quality
Requirements, evidence, and documented judgment.
Velocity
Source evidence prepared for monitor review.
More focus for clinical judgment.
The model is designed to focus monitor time on assessment, site dialogue, and follow-up. We work with you to define the monitoring scope and evaluate the business case for your study.
Two ways to work with us.
A first conversation covers your study, its sites and documents, and which way of working fits. We reply by email to arrange a time.
Discuss monitoring for your study Please do not include patient data.Our monitors, on our own platform.
Loopa as your clinical monitoring FSP (functional service provider), with scope agreed per study. You see each Loop, its evidence and each decision.
For sponsorsYour monitors, on our platform.
For CRO and sponsor teams with their own monitors. The same platform; your monitors decide each Loop.
For CROs