Clinical Trial Design for GI Research
Our team creates study designs that research sites can run effectively and regulatory bodies can review with confidence. We deliver a protocol geared to meet study objectives and endpoints and the operational framework to support it:
- Protocol and study plan
- Objectives and endpoint definition and confirmation
- Statistical methodology
- Randomization and stratification scheme
- Case report form (CRF) outline and CDISC standards
- Resource planning and budget considerations
Adaptive Trial Design
When appropriate, we design adaptive trials that allow for course correction without compromising integrity. Interim data are segregated to an unblinded statistician, and timelines, data cuts, and central reading needs are planned up-front.
Guidance From
Strategy to Submission
Our biostatistics team partners with you early on endpoints and models, then stays with your program through tables, listings, and figures (TLFs) and submissions:
- Deliverables: Statistical analysis plans (SAPs) and mock shells, simulation reports, and DMC/IDMC charters
- Advanced methods: Multiplicity control, missing-data strategy, longitudinal and time-to-event models, Bayesian options when appropriate, and PK/PD support
- Submission ready: CDISC SDTM/ADaM mapping, Define.xml, quality-controlled programming, and rapid responses to regulator questions
Proof You Can Point To
Our team has more than 30 years of experience designing and planning clinical trials for various gastrointestinal indications.
