Four services, all delivered at the site.
Everything below happens at the physical practice where the trial is conducted — we don't run a separate facility that pulls patients away from their own doctor.
Site Feasibility & Study Start-Up
Before a practice takes on a trial, we assess whether its patient population, staff capacity, and facilities can actually support the protocol — and we're honest when the answer is no. For sites that qualify, we manage IRB submission, contract and budget negotiation with the sponsor, and staff GCP training.
- Protocol review against the site's real patient population
- IRB submission and regulatory document preparation
- Sponsor contract and budget negotiation
Patient Recruitment & Enrollment
Recruitment is the single most common reason trials fall behind schedule. We build recruitment plans specific to each site's patient base — chart review, physician referral pathways, and community outreach — rather than relying on generic advertising that rarely reaches the right participants.
- Eligibility screening against protocol criteria
- Referral pathways built with the site's own physicians
- Informed consent process management
Regulatory & GCP Compliance
Ongoing compliance management for the life of the trial — FDA Form 1572 documentation, delegation logs, staff credentialing, and audit preparation, so the site is ready for a sponsor monitoring visit or an FDA inspection at any point.
- Delegation of authority and credentialing management
- CRA monitoring visit preparation
- Audit and inspection readiness
Data Management & Quality Assurance
Clean, protocol-compliant data collection and entry, with regular internal quality checks so discrepancies get caught by us before a sponsor's monitor catches them first.
- Case report form completion and query resolution
- Source document verification
- Internal quality audits ahead of sponsor monitoring
We're not a CRO.
A Contract Research Organization designs the study, plans the statistical analysis, and coordinates dozens of sites across a trial. We work at the site level, on behalf of the practice, to make sure that single site runs well — a genuinely different role, and one we're careful never to overstep.