Clinical research support for Independent Sites
Independent Research Sites & Site Networks
Small teams wearing many hats. Regulatory submissions and budget negotiations are slowing everything down.
Your Challenges
What slows you down, and what we do about it
- Small teams wearing many hats across multiple studies
- CRC staffing and regulatory coordinator support so your investigators and coordinators can focus on patients.
- Regulatory binders and IRB submissions slowing activation
- Site activation packages: regulatory binder, IRB/EC submission, and essential documents, quality-checked.
- Budget and contract negotiations delaying study start
- Contracts and budget support that knows what sponsors will and will not move on.
- No time to build SOPs or prepare for inspections
- SOPs, work instructions, and inspection preparation sized for a small site.
Roles We Place
Professionals who fit Independent Sites
Clinical Research Coordinator (CRC)
Runs the study at the hospital or clinic: recruits and consents patients, schedules visits, collects data, and acts as the link between patients, doctors, and the sponsor.
Regulatory Coordinator
Prepares and maintains IRB submissions, regulatory binders, and essential documents at the research site.
Study Start-Up Specialist
Gets trial sites ready to enroll patients. Collects and reviews essential documents, prepares IRB/EC submissions, tracks approvals, and coordinates with sites so each one opens on time and in compliance with Good Clinical Practice (GCP).
Site Contracts & Budget Specialist
Negotiates clinical trial agreements and budgets between sponsors and sites. Delays here are one of the most common reasons trials open late.
Fixed-Scope Packages
Defined deliverables when you need an outcome, not a headcount
Site Activation Sprint
Full startup support for one or more sites through activation.
Regulatory Start-Up Package
Regulatory binder, IRB/EC submission, and essential documents, quality-checked.
ICF Development & Harmonization
Plain-language consent form plus site-specific negotiation across your trial sites.
TMF Health Check
Completeness and quality review of your Trial Master File with a remediation plan.
Inspection Readiness Review
Gap assessment of regulatory files and TMF before an audit or inspection.
Activation Cycle-Time Assessment
Stage-by-stage analysis of your startup timeline, the bottlenecks, and a fix-it plan.
Coverage & Backfill
A time-boxed regulatory coordinator or CRC for leave coverage or open roles, with a documented handover.
Fractional Clinical Lead
A senior startup or clinical operations lead, part-time, embedded in your team.
From Our Team's Experience
Related work
Work our clinical research lead has led in prior roles, presented to show the depth behind the practice.
Leading complex activations at a top cancer center
We directed study startup across a multi-specialty oncology portfolio at an NCI-designated cancer center, managing cross-departmental coordination and a startup team.
Read moreMulti-department activation portfolioUsing cycle-time metrics to find activation bottlenecks
We tracked stage-by-stage cycle times across a multi-department activation portfolio, built dashboard reports, and surfaced the specific bottlenecks slowing study startup.
Read moreOncology: Phase 3Activating sites for a global Phase 3 oncology trial
We led multi-country site activation for a Phase 3 trial in a hard-to-treat gastrointestinal cancer, building reusable startup standards along the way.
Read moreGet Started
Need clinical research support?
Tell us about your trial and timeline. We will scope support sized for Independent Sites.
For Professionals
Join our clinical talent network
Experienced clinical research professionals. Tell us about your background.