Description
Clinical Trial Design Consultancy
From pilot studies to Phase I–IV trials, the design decides whether a trial answers its question and satisfies regulators. Our clinical research specialists help you define endpoints, sample size and the statistical and regulatory framework, and write the supporting documents.
What you receive
- Trial design for pilot or Phase I–IV studies
- Primary and secondary endpoint definition
- Sample size calculation
- Statistical analysis plan outline
- Regulatory guidance, including FDA submission support
- Protocol writing support
How it works
- Consultation on the intervention, population and objectives
- Design options and endpoints agreed
- Sample size and analysis framework developed
- Protocol and regulatory documents drafted
Standards we follow
Designs follow ICH E6 (GCP), ICH E9 and SPIRIT guidance, and the requirements of the regulator you are submitting to.
Turnaround and price
About 30 days. Starting price $7,500; a final quote is confirmed once the scope is agreed.
Frequently asked questions
Do you write the full protocol?
Yes, protocol writing can be included in the scope.
Is this suitable for investigator-initiated trials?
Yes. We support both academic investigators and sponsors.
Questions before ordering? Contact our team or request a quote.
