Regulatory support from start-up to closeout
Regulatory work never stops, but your coordinators shouldn’t have to carry it alone. TrialSite supports your site through initial submission, ongoing maintenance and study closeout.
Request a quoteSupport across the study lifecycle
Initial submission
Preparing and assembling site start-up documents, coordinating initial IRB submissions, and organizing the essential documents sponsors request before activation.
Ongoing maintenance
Tracking and submitting amendments, continuing reviews and safety reports as required, keeping staff documents and training records current, and maintaining the regulatory binder.
Regulatory closeout
Preparing final reports and IRB closure submissions, reconciling essential documents and getting your files ready for close-out visits and archiving.
Built for busy site teams
Use us as an extension of your regulatory team, or as your regulatory function while you grow.
- Sites with a growing study portfolio and limited regulatory staff
- New or smaller sites building out regulatory processes
- Sites that need short-term help during start-up surges or staff transitions
How it works
Assess your needs
We learn which studies and which phases (start-up, maintenance or closeout) you need help with.
Agree on scope
You receive a quote and a clear split of who handles what between your team and ours.
Ongoing support
We keep your submissions and documents on track and keep your team informed.
Frequently asked questions
Can we use you for just one phase, like closeout?
Yes. You can engage us for initial submission, ongoing maintenance, closeout, or any combination.
Do you work with central and local IRBs?
We support the IRB submissions your study requires. Let us know which IRB(s) you work with when you request a quote.
Who signs regulatory documents?
Documents that require site or investigator signatures are still signed by your PI and staff. We prepare, organize and track.
How is regulatory support priced?
It depends on the number of studies and the scope of work. Request a quote for a proposal.