Co-create in the Studio
Clinical strategists, regulatory scientists, statisticians, usability engineers, and health-economics experts draft a global protocol in a single sprint.
Co-create in the Studio
Aligns FDA, MDR / IVDR, and payer expectations in a single sprint, giving you a globally accepted and effective protocol from day one.
Run the Engine
Every endpoint is aligned with approval and coverage criteria for early payer feedback. Leverage regulator feedback channels or our commercialization team’s payer panels.
Run the Engine
Align every endpoint with the standards regulators use for approval and payers use for reimbursement. Additionally, tap into our commercialization payer panels in 30 + countries, so your data story resonates with both audiences.
Stay Efficient & Adaptive
Use Bayesian and frequentist adaptive designs to trim sample size and timelines while preserving study power and integrity.
Stay Efficient & Adaptive
Adaptive designs, supported by US/EU regulators, let us modify enrollment or endpoints based on interim data, so you reach answers faster with fewer participants and uncompromised statistical rigor.
Trial Design
Trial Design
Optimize study design and sample size so endpoints resonate with regulators and payers alike.
Regulatory Consulting
Regulatory Consulting
Navigate MDR/IVDR and FDA pathways with seasoned specialists who accelerate your path to approval.
Commercialization & Market Access
Commercialization & Market Access
Pair regulatory approval with payer-ready evidence by leveraging reimbursement strategies that synchronize coding, coverage, and pricing.
Human Factors
Human Factors
Minimize use-related hazards and slash recall risk by integrating human factors testing from concept through clinical trials.
