At Geistek, we don’t just run trials, we design them. Our Strategic Study Design service ensures protocols are scientifically sound, regulatory compliant, patient-centric, and optimized for success from the start.
We deliver integrated design planning across clinical, regulatory, and strategic considerations:
Our scientific, clinical, regulatory, and statistical experts collaborate at the design stage to ensure alignment.
Protocols incorporate regulatory expectations (FDA, EMA, etc.) and precedent to avoid deficiencies later.
We simulate outcomes (power, PK/PD response, dropout) and iteratively optimize design parameters.
Design aligns with real-world recruitment realities, retention, and ethical balance.
Seamless integration of adaptive designs, interim analyses, platform and basket trial approaches when supported by evidence.
Internal peer review, risk assessment, and scenario stress-testing.
A well-crafted study design increases probability of success, controls costs, and shortens timelines.
