Evolving Regulatory Environment
Evolving Regulatory Environment
Advocacy and Policy
Developing Real-World Data and Evidence to Support Regulatory Decision-Making
Framework for FDA’s Real-World Evidence Program
FDA cancer office taps Syapse for real-world evidence development
Pivotal Study Validates Real-World Mortality Endpoint for Oncology Research
Congress passes 21st Century Cures Act, boosting research and easing drug approvals
Biomarker Driven Studies
Statistical methods for establishing optimal treatment rules for matching patients to therapy.
learn more
Seamless Trial Designs
Designs to consolidate the phases of drug development through rapid cohort expansion.
learn more
Master Protocols
Designs to simultaneously evaluating multiple drugs and/or disease populations in multiple substudies, allowing for efficient and accelerated drug development.
learn more