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Real-World Evidence and Registry Data Analysis Services

Pubrica analyses real-world and registry data for researchers, life-science companies and health technology assessment submissions. We construct study cohorts from routine data, control for confounding with methods suited to the design, and report the analysis to STROBE and RECORD, so that the evidence can be assessed by journals, regulators and payers.

  • Target trial emulation used where a causal question is asked of observational data
  • Confounding addressed explicitly, with propensity score, weighting or other methods justified
  • Sensitivity analyses for unmeasured confounding, missing data and key definitions
  • Reporting to STROBE and RECORD, with code lists and definitions supplied
  • Fitness of the data assessed before the analysis is designed
What you receive

Protocol and statistical analysis planIncluded

Analysis code and code listsIncluded

Results tables and figuresIncluded

Study report or manuscript sectionsIncluded

Sensitivity analysis summaryIncluded

Service Scope

What Our Real-World Data Analysis Service Covers

Each project is scoped individually. The components below are combined according to your study and its requirements.

Study design Protocol and analysis plan, including target trial emulation where appropriate.
Cohort construction Eligibility, index dates, exposure and outcome definitions from routine data.
Confounding control Propensity score matching, weighting, stratification and regression adjustment.
Time-to-event and longitudinal analysis Survival models, competing risks and time-varying exposures.
Sensitivity analyses Negative controls, E-values and alternative definitions.
Reporting Methods and results reported to STROBE and RECORD.

Applications

Typical Applications of Real-World Data

Comparative effectivenessTreatments compared in routine care.
Safety studiesPost-authorisation safety outcomes.
External control armsComparators for single-arm trials.
HTA submissionsEvidence for payers and HTA bodies.
Disease burdenIncidence, prevalence and treatment patterns.

Process

How the Project Works

Methods, deliverables and fees are confirmed in writing before work begins.

01 Question and data reviewWe define the question and assess whether the available data can answer it.
02 Protocol and analysis planDesign, definitions and methods are agreed and documented before analysis.
03 Cohort and analysisCohorts are constructed and the planned analyses run, with code reviewed.
04 Sensitivity analysesThe robustness of the findings is tested against key assumptions.
05 ReportingResults are reported to STROBE and RECORD for publication or submission.

FAQs

Frequently Asked Questions

If your question is not answered here, ask an expert.

Real-world data can support causal conclusions only under assumptions that must be stated and tested. We design the analysis to make those assumptions explicit.

It specifies the randomised trial that would ideally answer the question and then designs the observational analysis to mirror it, which avoids several common biases.

Registries, EHR, claims and linked datasets, subject to the access arrangements and approvals for each source.

Yes. The methods and results are reported to these guidelines, with the code lists and definitions supplied.

Request a Feasibility Review of Your Real-World Data Question

Describe the question and the data source. We assess whether the data can answer it and confirm the design, deliverables and fee.

Get a free quote

Regulations

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What do you need?

Material you send is held under signed confidentiality, with access limited to the assigned team and encrypted transfer. It is not used to train anything and is not passed to third-party tools. Ask for the agreement before you send anything you would rather cover first.