IIS Support
Investigator-initiated studies (IIS) are a vital driver of clinical innovation — but they come with the same regulatory requirements as sponsor-initiated trials, often on a fraction of the budget. Medwave has built a specialized service model around exactly this challenge.
"Designing, initiating and executing an investigator initiated trial must fulfill the same general requirements as sponsor initiated trials — including ICH-GCP, insurance, local regulations, and safety reporting. We structure our services so that none of this is compromised, regardless of budget."
How We Support You
Trial Design
Protocol writing and study design optimized for scientific value and regulatory acceptance.
Study Initiation
Regulatory submissions, ethics approvals, and site set-up handled from start to finish.
Study Execution
Monitoring, data management, safety reporting and study closure — full ICH-GCP compliance throughout.
Budget-Conscious Pricing
We recognize that IIS budgets operate at a different level and price our services accordingly.
Sponsor Services
Medwave can act as the official legal sponsor, taking on full financial administration and accountability.
Regulatory Compliance
ICH-GCP, local regulations, insurance requirements and safety reporting — all covered.