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Clarrio.ai

Pharma & biotech

Connect longitudinal patient data for real-world evidence research

Investigate disease trajectories, treatment exposure and patient experiences in real-world settings. Clarrio.ai aligns clinical, treatment and behavioral observations to support defined research questions.

Program · Phase 2/3 to post-launchIllustrative
Phase 2/3LaunchPost-launch
Site visitsContinuous record with Clarrio.ai

The challenge

Trials and launches still run on snapshot data

Evidence teams depend on site visits, paper diaries and retrospective claims or EHR extracts. Each source sees a slice: claims show what was billed, EHRs show what happened in clinic, and diaries show what patients remembered. What patients experience day to day, after enrollment and after launch, is largely missing, and long-term follow-up is costly to sustain through sites.

Toggle the chart to compare what a visit-based record shows with what the continuous record shows for the same synthetic patient.

PRO score (0–24) over 120 days

Observations3

Events in periodNot visible

Events with no nearby visit3 of 3

Three protocol visits show gradual improvement. Weekly PROs show two fluctuations and a response after a dose change that the visit schedule did not capture.

Illustrative · synthetic data

Site burden

Visits are expensive

Every additional assessment adds cost for sites and participants.

Diaries

Incomplete data

Paper and recall-based diaries weaken endpoints.

Post-launch

Evidence gap

Real-world response data after approval is limited and slow to obtain.

Longitudinal health intelligence

Investigate disease, exposure and everyday experience together

Align clinical observations, medication or intervention history, and daily-life context without losing source meaning. Available data and review boundaries depend on the program.

One person / one shared timeline

Illustrative research data · Synthetic demonstration

Health and disease trajectories

Reported fatigue burden

Treatments and interventions

Exposure · dose · reported experience

12345678

Behavior and daily life

Average daily activity

Shared time axis / weeks

Week 4 / Disease4 /10 · Structured experience report

Week 4 / TreatmentInterval · No administration recorded this week

Week 4 / Behavior25 min · Short walks resumed

Open related use case

Separate measures and independently scaled channels; values appear in their own units. Temporal alignment does not establish causality.

Use cases

Evidence across the product lifecycle

Trial enrichment & digital endpoints

Between-visit data to support enrichment and digital endpoint work.

Long-term follow-up

Years of follow-up after one-time and gene therapies, without constant site visits.

Rare disease natural history

Continuous natural-history data across dispersed patient populations.

Market access / HEOR

Real-world outcomes evidence for payer and HTA conversations.

Patient support programs

An engagement app that supports patients and captures what matters.

Implementation

Deploys alongside your protocol, not instead of it

  1. 01

    Scope the evidence question

    Endpoints, populations, regions and data channels.

  2. 02

    Activate partner sites

    Center-agnostic, worldwide: US, Middle East, Europe.

  3. 03

    Patients onboard

    Sites begin collection after protocol, consent, configuration, and source checks.

  4. 04

    Continuous harmonized data

    One longitudinal record per patient, across sources.

  5. 05

    Evidence delivery

    Exports and views for clinical, medical affairs and HEOR.

  • Works alongside CROs without changing the sponsor protocol
  • Center-agnostic, worldwide deployment
  • Collection starts after site and governance checks

Benefits

How longitudinal data supports research and care workflows

  • Richer, continuous data between site visits
  • Evidence that follows the product past approval
  • Lower burden for patients and sites
  • Harmonized data ready for analysis

Benefits in practice

Benefits and evidence needs across stakeholder roles

Pharma & biotech

Start with the evidence question a decision-maker actually needs answered

Routine records can describe encounters and prescriptions while leaving daily function, symptom burden and experience under-observed. Adding remote data can fill selected gaps, but a large dataset is not automatically decision-ready. Population selection, questionnaire suitability, exposure timing and missing observations can all change the interpretation of a longitudinal analysis.

  1. 01

    Specify the evidence objective

    Define the population, observation window, outcome concept and intended decision before selecting sources.

  2. 02

    Collect and reconcile

    Combine appropriately scoped Patient App reports with available clinical and device data in the Platform; keep reported experience separate from recorded events.

  3. 03

    Review before analysis

    Use source-aware review to inspect context and quality. Agree variable definitions, analysis methods and limitations with the study team.

For the professional team

Clinical development, medical affairs and HEOR teams can work from a common record while asking different questions. Clinical operations needs coverage by site and timepoint; an evidence analyst needs definitions and provenance; medical affairs needs an account of the population and study limitations. Those outputs should not be treated as interchangeable.

For patients, members and caregivers

Participants have a structured way to contribute the experience that encounters may miss. Questions should be meaningful, proportionate and appropriate to the population. Explain the study purpose, who reviews submissions and whether reporting receives an individual response; a research diary is not an emergency service.

For payers and program funders

A payer-facing evidence package should connect patient experience to a defined decision question and relevant population. Include baseline characteristics, follow-up, missingness and the analysis method. Patient-reported experience can complement other evidence, but it does not alone establish comparative effectiveness, economic value or a coverage recommendation.

Illustrative review brief
Population definition
Eligibility, enrollment dates and relevant baseline characteristics
Longitudinal variables
Source, units, assessment window and missing-data conventions
Evidence limitations
Selection, confounding and generalisability to the decision population

Workflow illustration · not a customer result or live record

What to evaluate before making a claim

Assess suitability against the research question: provenance, completeness, accuracy and relevance. Predefine the analysis rather than choosing a favorable pattern after viewing the results. Publication and payer use require appropriate scientific review.

Explore evidence and evaluation

Payers & health economics

Distinguish richer patient context from evidence of value

Claims and encounter datasets can describe recorded utilization without fully capturing function, experience or the practical burden of a program. Patient reports add a different perspective, but they can be incomplete or drawn from a population unlike the members covered by a payer. The task is to establish whether those observations are suitable for a specific appraisal question, not to turn engagement into a savings claim.

  1. 01

    Define the appraisal question

    Specify the relevant covered population, decision, comparator where needed and evaluation horizon.

  2. 02

    Assess data suitability

    Review provenance, participation, measurement windows and missingness before examining results.

  3. 03

    Build the evidence account

    Combine appropriately governed patient experience with relevant clinical or utilization evidence; document assumptions and limits for expert appraisal.

For the professional team

HEOR and population-health teams can examine how reported experience varies across the observation period and which groups are represented. A useful output explains the denominator behind a measure and the observations excluded from analysis. Governance must also define the permitted purpose of any linkage to payer-held data.

For patients, members and caregivers

The member perspective should remain visible in a program evaluation: burden, everyday function, access and what participants consider meaningful. Reporting should not become an unexplained condition of receiving services. Explain the collection purpose and permitted uses in a way members can understand.

For payers and program funders

Decision support means an inspectable evidence package, not an automatic reimbursement verdict. Include the target population, relevant baseline differences, data sources, follow-up and limitations. Cost and utilization conclusions need appropriate data and analysis; neither can be inferred from app activity or observation coverage.

Illustrative review brief
Decision context
Population, appraisal question and evaluation horizon
Suitability account
Provenance, completeness, accuracy and relevance
Interpretation boundary
What the analysis can support and what remains uncertain

Workflow illustration · not a customer result or live record

What to evaluate before making a claim

Separate program participation, patient-reported experience, clinical outcomes and economic endpoints. Define each before collection, use an appropriate comparison where the question requires one and examine whether findings transfer to the covered population.

Explore evidence and evaluation

Patients, members & caregivers

Give the person contributing data a meaningful place in the workflow

A person can complete many questions without understanding why they are being asked or who will read the answers. Device observations may look precise while missing personal context. A useful longitudinal journey starts with the person's priorities and makes the reporting purpose, burden and review arrangements understandable.

  1. 01

    Explain the purpose

    Agree what the care or research program needs to learn and what participation involves.

  2. 02

    Capture lived experience

    Use appropriate reports alongside available observations; distinguish the patient's own answers from caregiver observations.

  3. 03

    Bring context to review

    Discuss a dated interval with the responsible professional, including what is missing and what matters to the person.

For the professional team

Teams gain context for a more specific conversation, but should not assume that a missed report means a person disengaged. Accessibility, fatigue, language and connectivity may affect reporting. Define support and review arrangements before introducing new questions.

For patients, members and caregivers

Patients and members can keep a dated account of experiences they might otherwise forget. Caregivers can contribute observations when appropriately scoped, without replacing the person's own perspective. Personal patterns invite discussion; they are not instructions or proof that a particular routine produced an outcome.

For payers and program funders

A program's apparent reach can hide who could not participate. Payers and commissioners should examine access, reporting burden and representativeness alongside outcome evidence. Patient experience is an important perspective in appraisal, not a shortcut to an economic conclusion.

Illustrative review brief
Personal context
The person's own priorities and dated reports
Reporting perspective
Patient answer or appropriately identified caregiver observation
Review arrangement
Who reviews reports, when and through which contact pathway

Workflow illustration · not a customer result or live record

What to evaluate before making a claim

Ask whether reporting is understandable, manageable and meaningful. Examine completion alongside accessibility and support needs. A high completion rate alone does not show that people feel heard or that a program has improved their health.

Explore evidence and evaluation

What each stakeholder receives

Longitudinal data outputs by stakeholder role

Clinical development

  • Between-visit response data
  • Support for digital endpoint work

Medical affairs

  • Real-world insight on how therapy is used
  • Long-term follow-up data

Market access / HEOR

  • Real-world outcomes for dossiers
  • Evidence for payer conversations

Data science

  • Harmonized longitudinal datasets
  • Exports and APIs

Patients

  • A supportive app
  • Fewer site trips

Product workflow

How the record is built, step by step

Select a step to see what happens. Sources are captured through the Patient App and integrations, harmonized on the Platform and summarized by Intelligence.

Sources

  • Patient App PROs & diaries
  • Wearables
  • Site & EHR data
  • Labs
  • CRO systems

Clarrio.ai workflow

Outputs

  • Analysis-ready dataset
  • Completion dashboard
  • RWE package

Stakeholder outputs

Role-specific views of the longitudinal record

Each role receives a different view of the same longitudinal record. Values are synthetic.

Clinical operations

Completion dashboard

Track PRO completion by site and week, and see where follow-up is slipping.

Clarrio.ai / Completion dashboardSynthetic
  • Site 0382%Weekly PRO completion
  • Site 07LowReminders adjusted
  • Overall88%Last 4 weeks

Medical affairs

Real-world response

Consented, aggregated trajectories after launch support scientific exchange and evidence planning.

Clarrio.ai / Real-world responseSynthetic
  • Cohort320Post-launch, consented
  • MeasuresPROs, wearablesHarmonized
  • ReportQuarterlyDescriptive trends

HEOR

Dataset export

Person-week datasets with a data dictionary, ready for analysis.

Clarrio.ai / Dataset exportSynthetic
  • FormatCSV / ParquetWith dictionary
  • LinkageSite + remoteOne record per participant
  • GovernanceConsentedDe-identified

Worked examples

Two illustrative scenarios

Sponsor and CRO

An MG trial with weekly PROs

  1. Week 0

    Participants onboard via the app at the site visit.

  2. Weekly

    MG-ADL and fatigue reported remotely.

  3. Week 8

    Completion dashboard flags one site for support.

  4. Database lock

    Remote and site data delivered as one dataset.

Illustrative · synthetic data

Medical affairs

Post-launch evidence

  1. Launch

    Patient program offers the app.

  2. Months 1–6

    Consented real-world response captured.

  3. Month 6

    Descriptive report supports evidence planning.

Illustrative · synthetic data

Evidence

Evidence status and research review boundaries

Mayo Clinic Platform review

Joined Mayo Clinic Platform's Solutions Studio; participation is not clinical validation.

Research-specific ethics review

Required approvals depend on the research protocol and responsible institution.

Evidence status

Patient counts, observation periods and evidence reviews are stated per study.

Not a medical device

Clarrio.ai does not diagnose, treat, or replace clinical judgment.

FAQ

Questions about pharma & biotech

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Explore disease, treatment and behavior together

Explore how clinical, treatment and behavioral information align around your program and the research or review questions your team needs to answer.

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