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Lumiveer
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Clinical trial oversight software

Oversightyou can prove.

For CROs and biotech sponsors. Review site risks, investigate signals, and keep every response linked to its evidence.

Request a walkthroughSee how it works

Product walkthroughs now; paid design-partner pilots later.

Original signalRS-2047

Site 0427

SAE reporting interval

+3.2σIllustrative median: 36 hours
UCL +3σ
Study day 148

The original signal stays linked. A signed response does not erase it.

LUM-204 / RS-2047Example record

The response.

Context preserved

Linked review record · 1 of 4

Start with the source

Day 148

Illustrative extract: median delay 36 hours. Awareness/onset dates and report timestamps retained.

LUM-204_safety-reporting.csv

Give the review an owner

Day 149

Alex Morgan, illustrative safety lead. Review assigned; due on study day 151.

Document the handoff delay

Day 151

Illustrative finding: site-to-safety handoff delay. Handoff review requested; follow-up stays open.

Preserve the signed review

Day 152

Alex Morgan signs the review record. The handoff review and reporting follow-up remain open.

Illustrative signature
Original signal retained. Response documented.

Each ribbon is one site's illustrative deviation over time.

Illustrative scenarios and people. Standardized trends.
Delayed safety reporting: The living study
Explore an issue
Scroll to follow the signal

Scroll to follow the signal

Continue to product overviewSkip story
How Lumiveer works

From study data to a documented response.

Bring study data, risk signals, and follow-up into one oversight workflow.

  1. Import study data

    Upload CSV or Excel files. Confirm field mappings and reuse them for future imports.

  2. Review signals

    Review indicator results and unusual site patterns against configured limits.

  3. Investigate and assign

    Review source data, document findings, and assign an owner and due date.

  4. Record the response

    Keep evidence, reviewer notes, and the signed response linked to the original signal.

Clinical trial oversight for CROs and biotech sponsors.

Seeing the riskis the beginning.

The useful question comes next: who reviewed it, what did they find, and where is the record? Lumiveer keeps that response connected to the signal.

Explore the indicators
LUM-204
Safety
Example record

RS-2047

Site 0427+3.2σ

  1. Source retained
  2. Owner named
  3. Finding documented
  4. Response signed
The original signal stays linked. A signed response does not erase it.

Know what needsa closer look.

69 built-in indicators across five oversight areas. Explore the checks behind the numbers, from safety reporting to overdue actions.

69built-in indicators

5 oversight areas

11 safety indicators

Safety

Are safety events being reported promptly and followed through?

  • SAE onset-to-report time

    See how long serious adverse events take to reach the reporting record.

  • AE under-reporting score

    Identify unusually low reporting relative to the study’s expected pattern.

  • Overdue SAE follow-up

    Bring outstanding follow-up into the review queue.

View all 11 safety indicators
  • AE Coding Accuracy
  • AE Documentation Lag
  • Resolved AE Outcome Missing
  • AE Relatedness Missing Rate
  • AE Reporting Rate
  • AE Severity Missing
  • AE Under-Reporting Score
  • Overdue SAE Follow-up
  • SAE Onset-to-Report Time
  • SAE Rate
  • SAE Proportion of AEs

Choose the measures that fit your study. Configure study-specific limits or compare sites statistically. Results depend on the data available; a flagged indicator starts a review, not a conclusion.

Data intake, around your workflow

Less time preparing data.More time reviewing it.

Start with the exports you already have. Work with us to build the right path from your source systems into Lumiveer.

File imports

Map once. Reuse the setup.

Upload CSV or Excel files. Review suggested column mappings, confirm how values should be read, and reuse that mapping when the same source format arrives again.

  • Suggested field mappings
  • Reusable, confirmed import profiles
  • Import progress and error reporting
Partner integration

Plan the connection together.

We can work with your team to scope API access and recurring data refreshes. Lumiveer’s connector framework provides a starting point for bringing source data into a consistent oversight workflow.

  • Agree the source and data permissions
  • Map records and define the refresh cadence
  • Test the connection and review the results

API connections and scheduled refreshes are scoped with each partner. Setup depends on the source system, available access, and the checks your study needs.

Discuss your data setup
AI that supports the site conversation

Less searching.Better site conversations.

Connect available study records, surface gaps, and prepare observations your team can review with a site.

Illustrative workflow

Choose a question. Follow the evidence into the draft.

What is holding up the responses?

Site 0316 · Sample records

Available evidence Select a record to inspect it

Open query age

The site's open-query-age indicator is 40 days in this example. This is an aggregate measure, not the age of every query.

Illustrative AI draftNeeds more data

Two queries remain open without a recorded response. The available records do not explain the delay.

Trace an observation to its sources

Evidence: A backlog worth checking

Open query age

The site's open-query-age indicator is 40 days in this example. This is an aggregate measure, not the age of every query.

Your team takes the next step

Confirm the outstanding source checks with the site, agree who will respond, and document follow-up.

A focused query discussion, with the supporting records at hand.

Interactive examples with prepared records and observations. Your team reviews each AI investigation and records its decision. AI setup and evaluation are part of pilot planning.

Explore AI-assisted review
Concomitant medication review

Different medications.Different restrictions.

Compare recorded medications with protocol restrictions: exact names, brand/generic associations, and possible drug-class matches.

Three illustrative medication cases. Each is paired with a different study protocol.

Choose a medication

Medication record CM014

Medication name as entered

Coumadin

Brand name

Original wording retained

LUM-204 · Illustrative protocol
Section 7.1.2.1

Prohibited concomitant medications

Therapeutic anticoagulation (including warfarin or direct thrombin inhibitors) is prohibited from 7 days before the first dose of study treatment through completion of the final study visit.

Low-dose prophylactic anticoagulation is permitted only if the participant satisfies the protocol’s PT/PTT eligibility criteria.

AI-assisted brand/generic comparison

A brand name points to a listed anticoagulant.

Coumadin is a brand name for warfarin sodium. This connects the medication record to the anticoagulant restriction. Dose, indication, and timing still need review.

Screening identifies a potential match. A reviewer checks whether the restriction applies.

Name association: DailyMed drug label

Coumadin. LUM-204, section 7.1.2.1. Compare. A brand name points to a listed anticoagulant.

Your protocol defines the list. AI can extract candidate prohibited medications from a protocol PDF. A person reviews and approves them before the list becomes active.

Text first. AI when requested. Lumiveer checks exact and contained names first. AI-assisted review can suggest name or drug-class associations; the reference evidence and protocol context need verification.

Prepared examples using fictional study records and adapted protocol excerpts. These illustrate the review workflow; live AI accuracy requires evaluation during pilot setup.

See medication review in a walkthrough

Oversight from plan to follow-up.

Define the risks that matter to your study, review signals in context, and keep the next action connected to an owner and a due date.

Start with study risks

Build study risk assessments and link assessed risks to indicators. Keep your oversight priorities connected to what you monitor.

Keep study-level limits visible

Define quality tolerance limits, review recorded breaches, and link follow-up actions. Look across the study as well as at individual sites.

Follow through on the response

Track assigned actions, due dates, and issue closure. Keep reviewer notes, audit history, and electronic-signature features alongside the work.

Design-partner pilots

A product to explore.A voice in what comes next.

See Lumiveer in a personal walkthrough. If it fits your team, explore a paid pilot with preferential design-partner pricing when pilots open.

Help shape the next chapter

Bring your workflow.
Influence what comes next.

  • A walkthrough of the existing product
  • Preferential pricing for a paid pilot
  • Direct feedback conversations with the builder

We’ll discuss your goals, pilot scope, timing, and pricing together. Registering interest does not commit your team to a pilot.

Request a walkthrough
Let’s take a closer look

See Lumiveer.Talk through your workflow.

Tell us a little about your team. We’ll follow up personally to arrange a walkthrough or discuss your interest in a design-partner pilot.

Please leave out patient details or confidential study information.

A personal follow-up. No account creation or payment required.

A few things, answered.

Can we see the product now?

Yes. Request a personal walkthrough of Lumiveer. We’ll follow up to arrange a time and learn what matters to your team.

What does being a design partner involve?

A future paid pilot at preferential pricing, with direct feedback conversations to help refine the product. We’ll agree on scope, timing, and terms together before a pilot begins.

When can we start a pilot?

Product walkthroughs are available now, and we’re collecting interest in future paid design-partner pilots. Pilot timing will be discussed individually; requesting a walkthrough does not create an account or enroll your team.

Can we use Lumiveer for oversight without a formal RBQM program?

Yes. Start with the oversight work your team already does: reviewing site performance, following safety and data-quality signals, assigning actions, and documenting decisions. Lumiveer can support those workflows while you develop or refine your RBQM approach. Your study plans and team remain responsible for how it is used.

Can you help automate data intake or connect our systems?

Yes. CSV and Excel imports support suggested field mappings and reusable, confirmed mapping profiles. Lumiveer also has an API connector framework and an implemented Castor connector. We can work with your team to scope API access, data mapping, and recurring refreshes for a pilot. Availability depends on the source system and permissions; each connection needs setup and testing.

How does AI support oversight?

AI can investigate a selected signal, gather related records, summarize possible contributing factors, and draft follow-up suggestions. It can also help review medication names against study-specific exclusions. Your team reviews the output and decides what happens next. AI features require configuration and evaluation as part of pilot setup.

Does a signal mean a site has a confirmed problem?

No. A control-limit breach identifies a statistical pattern for investigation. The source data, clinical context, and a qualified person's review determine what it means.

Is Lumiveer certified or validated for our study?

No certification is claimed. Intended use, validation, qualification, and applicable requirements must be reviewed for your organization and environment. Electronic-signature and audit-trail features alone do not establish compliance.

Who is building Lumiveer?

Lumiveer is being built by Shivam Patel, a clinical operations practitioner with hands-on experience in clinical monitoring and oversight. You can see the existing product in a walkthrough, and future design partners will help refine it.

Give every signala story you can show.

From the first unusual value to the record of your response.

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