From early planning to final submission, SDC’s ISS/ISE services ensure your integrated summaries are consistent, compelling, and fully aligned with regulatory expectations.
Solutions Include:
- Submission strategy and statistical narrative planning
- Standardized data pipelines for multiple study integration
- Cross-functional collaboration with medical writing and clinical teams
- Anticipation of and response support for FDA questions and advisory panels
Whether you’re designing your first adaptive trial or scaling a multi-country program, we help you adapt without uncertainty. SDC’s adaptive trial design services give sponsors the freedom to evolve study parameters based on emerging data—all within a sound statistical framework.
