REAL-WORLD DATA ASSESSMENT
Know whether your real-world data is fit for use.
Orizaba Solutions helps life sciences organizations, pharmaceutical companies, and research partners determine whether RWD is fit for its intended use and turn that determination into an actionable evidence and FDA submission strategy.
PROCEED
Advance with a strong evidence plan
ADAPT
Close gaps or refine the study approach
REASSESS
Avoid investing in data that cannot answer the question
We use a question-driven assessment, not a generic data-element and quality review
Fitness for use is not an inherent property of data; it arises from the relationship between the data and its intended use. We begin by defining the decision to be informed and the role RWD will play. We then evaluate candidate data sources against practical and regulatory requirements.
The assessment includes more than 100 questions across five components: Study (or Intended Use) and Data Source Profile; Prespecification; Data; Feasibility; and Ethics, Privacy, and Regulatory. Questions are grounded in FDA RWD and RWE guidance, subject-matter expert judgment, and reviews of RWE-supported FDA submissions.
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Decision and data-source fit.
Clarify the intended use; compare candidate sources and alternatives against specific requirements.
Data fitness.
Assess relevance, reliability, completeness, representativeness, longitudinality, interoperability, and endpoint feasibility.
Variable Level Validity.
Determine whether exposures, outcomes, confounders, and covariates can be measured with sufficient validity.
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Traceability and transformations.
Review derived variables, AI-enabled methods, metadata, provenance, and transformation logic.
Feasibility Assessment.
Assess feasibility, including precision, limitations, mitigations, residual uncertainty, and decision impact.
Scalable governance.
Create reusable assessment frameworks, evidence packages, decision criteria, and governance processes.
What you receive
A transparent, decision-ready record: data-source comparison; fit-for-purpose findings; feasibility assessment; prioritized gaps and mitigations; residual-risk narrative; evidence roadmap; and a clear proceed, adapt, or stop recommendation. We can also support the documentation, traceability, and coordination needed to manage FDA submission requirements. Engagements can range from a focused data-source assessment to an FDA-ready fitness package or enterprise RWD assessment framework.