Service
US clinical programs
Sites, budgets, agreements, IRB, and start-up for a first study in the United States.
What this covers
An approved IDE is a permission, not a study. The study starts when a site has a signed agreement, an approved budget, IRB approval, trained staff, and devices on the shelf. For a first-time sponsor at a US academic cardiac center, that takes longer than the IDE review did.
Sites and investigators
We identify sites with the patient population, the investigator experience, and the research infrastructure the protocol needs, and we open the conversation. For cardiovascular devices this usually means leading US academic cardiac centers, where the negotiation is with an institution, not a person.
Budgets and clinical trial agreements
We negotiate the site budget and the clinical trial agreement on your behalf: per-subject costs, start-up fees, indemnification, publication, and intellectual property. We know what an academic center will and will not accept, and where the time goes.
IRB and start-up
Central or local IRB submission, the consent form, site initiation, and the sponsor obligations under 21 CFR Part 812: investigator agreements, device accountability, records, and the reports FDA requires, including unanticipated adverse device effects within ten working days.
When you need it
When the IDE is filed, not when it is approved. Site contracting at an academic center takes months, and IRB review runs on its own clock. Starting while FDA is still reviewing the application keeps approval and first enrollment close together.
What you receive
- Site list with rationaleWhy each center, what it can enroll, and who the investigator is.
- Executed agreements and budgetsNegotiated to a position you have approved.
- IRB packageProtocol, consent, and supporting documents ready for review.
- Sponsor obligations calendarEvery report and record Part 812 requires, with dates.
What we need from you
- Protocol and investigator brochureThe versions FDA approved.
- Device supply planHow many, when, and from where.
- Budget envelope and insuranceWhat you can commit per site and your clinical trial insurance.
Tell us where your program is.
We reply within 12 hours. You get a written scope and estimate before any work starts.