Service

Study design & protocol development

Most of the problems we are asked to rescue at the analysis stage were created at the design stage — and could not be fixed afterwards by any statistical method.

What should be decided before a clinical study starts collecting data?

Before data collection begins you should have a precise, answerable research question; a study design that can actually answer it; explicit eligibility criteria; clearly defined exposures, outcomes and covariates with their measurement instruments; a sample-size calculation based on the smallest clinically important effect; a pre-specified statistical analysis plan including how missing data and confounding will be handled; and a data-collection instrument built so that the variables arrive in analysable form. Each of these is far cheaper to fix now than after enrolment.

What this service includes

Research question refinement
Turning a broad clinical interest into a specific, answerable question with a defined population, comparator, outcome and timeframe.
Design selection
Randomised, cluster-randomised, crossover, cohort, case–control, nested case–control, cross-sectional, diagnostic accuracy, and pragmatic designs — chosen for the question and the constraints, not for convenience.
Sample size & power
Calculations for superiority, non-inferiority, equivalence and precision-based aims, inflated for clustering, stratification, interim looks and expected attrition, with simulation where no closed form exists.
Bias control by design
Randomisation and allocation-concealment schemes, blinding, matching, restriction, and a causal diagram identifying the minimal sufficient adjustment set.
Protocol writing
Full protocols aligned with SPIRIT for trials and with STROBE-compatible planning for observational studies, ready for ethics and registration.
Case report form design
Data-collection instruments and REDCap-style variable specifications built so the export is analysable without restructuring.
Pre-specified analysis plan
Estimands, primary and secondary analyses, missing-data strategy, subgroup plan and multiplicity control written down before the data exist.
Registration & ethics support
Registration text, ethics application statistics sections, and responses to methodological queries from review boards.

What you receive

  • Refined research question and PICO framing
  • Full study protocol
  • Sample-size justification paragraph
  • Causal diagram and adjustment set
  • Case report form / data dictionary
  • Pre-specified statistical analysis plan

Independently verified before it reaches you

Every primary result is reproduced from the cleaned dataset by a second statistician before delivery, and you receive the analysis scripts so any number in the manuscript can be traced back to a line of code and a row of data.

Common questions

Tell us about your project.

Book a free 15-minute consultation. Tell us the research question, the data you have, and the deadline — we will tell you honestly what is achievable.

Or call +20 100 163 8864 · Sunday–Thursday, 09:00–18:00 (GMT+2, Cairo)

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