Regulatory & Compliance Services
We help your team stay audit-ready and inspection-proof with expert regulatory support tailored to your site's needs.
Our Core Services
OnePath Research Services
In addition to our professional services, OnePath proudly offers free support services for clinical trial participants and patients. We help individuals understand consent forms, identify relevant clinical trials, and serve as a compassionate resource—offering guidance, clarity, and emotional support throughout their research journey.
OnePath Research Services
Regulatory support that keeps trials moving.
TMF Audits & Gap Assessments
We review your Trial Master File for completeness, accuracy, and compliance, identifying missing or outdated documents.
SOP Development & Customization
We create or refine Standard Operating Procedures to match your workflows and meet GCP and sponsor expectations.
Site Readiness Planning
From pre-study visits to mock audits, we ensure your site is fully prepared for activation and regulatory review.
Regulatory Binder Setup
We build or organize essential site binders with standardized, compliant documentation.
Request a no-cost site
assessment with OnePath.
Ready to streamline your documentation and take the stress out of audits?
Let’s Simplify Your Compliance Strategy
Book a free call with our consulting team today—we’ll help you build a plan that fits your timeline, your team, and your goals.