Focused engagement
RWE / Observational Data Fitness Sprint
A go/no-go assessment of whether observational data can credibly answer a specific scientific or comparative-effectiveness question.
When to use it
Best fit
Registry, hospital, healthtech, biotech or research teams deciding whether to fund a full real-world evidence analysis.
Scope
- Translate the question into a target population, exposure, outcome, time zero and estimand.
- Assess data coverage, provenance, missingness and fitness for purpose.
- Identify confounding, selection, measurement and time-related biases.
- Define feasible primary and sensitivity-analysis paths.
Inputs
- Scientific question and intended decision use.
- Data dictionary, provenance notes and representative metadata.
- Cohort construction rules and available quality summaries.
- Relevant protocol, registry or study documentation.
Deliverables
- Data-fitness and feasibility report.
- Target-trial or estimand framing where appropriate.
- Bias, confounding and missing-data risk map.
- Go/no-go recommendation and proposed analysis plan.
Data handling
Real patient or confidential study data remains within the client, sponsor, CRO or contractually approved environment. The permitted data, access model and retention rules are agreed before work begins.
Do not send patient, clinical or confidential study data.
Boundaries
- Does not turn unsuitable data into causal evidence.
- Does not include a full statistical analysis, data collection or clinical adjudication unless separately scoped.
- Any causal interpretation depends on explicit assumptions and supporting diagnostics.
Discuss this engagement
Confirm fit before sharing materials.
Begin with the study situation, intended decision and timing. Data access is agreed only after scope and safeguards are defined.