Regulatory & Compliance Support

We manage the compliance so you can focus on your patients.

Confident Participation Starts with Compliant Operations

Engaging in clinical research involves a complex web of regulatory requirements, documentation standards, and ethical oversight. At SAON, we simplify this process by taking responsibility for the day-to-day regulatory and compliance work that makes studies safe, ethical, and inspection-ready. You can participate confidently, knowing that our experienced team is keeping your site aligned with all applicable guidelines.

As your Integrated Research Partner, we ensure your study is conducted with precision, transparency, and full compliance—so you can focus on delivering excellent care and meaningful data.

Our Support Includes:

IRB and Ethics Committee Coordination

We prepare, submit, and track all required documentation to Institutional Review Boards (IRBs) or ethics committees. This includes initial applications, continuing reviews, amendments, and adverse event reporting. Our team ensures your site stays in good standing without adding extra paperwork to your plate.

Regulatory Document Management

From investigator brochures and informed consent forms to delegation logs and protocol amendments, we manage and organize every regulatory document required for your study. We maintain a complete and inspection-ready regulatory binder for each site, either digitally or in a physical format if required.

Good Clinical Practice (GCP) Oversight

SAON ensures that all activities at your site meet the highest ethical and clinical standards, in full alignment with FDA regulations, GCP guidelines, and sponsor expectations. We keep your team informed and your documentation audit-ready.

Ongoing Compliance Monitoring

We don’t stop at study launch. Our team continues to monitor compliance throughout the study lifecycle, supporting your staff with real-time issue resolution, audit preparation, and protocol adherence. If something needs correction, we help you fix it—promptly and compliantly.

Informed Consent Support

We assist with implementing and maintaining a compliant informed consent process, ensuring every participant fully understands the study’s purpose, procedures, risks, and benefits. Our approach protects patients and supports clean, defensible data.

Why It Matters

Even experienced practices can feel overwhelmed by the pace and complexity of study compliance. At SAON, we take the burden off your internal staff while raising the standard of your research operation. You’ll never have to second-guess whether your documentation is complete or your processes are aligned—we handle that for you.

Our Commitment to You

• Fully Managed IRB Process. We handle the entire cycle of IRB correspondence so you don’t have to.
• Inspection-Ready at All Times. Your site stays compliant and prepared for audits, with no last-minute scrambles.
• Clear, Organized Documentation. Every study file is maintained, reviewed, and securely stored to meet sponsor and regulatory standards.
• Support, Not Oversight. We work with your team, not around them, to make compliance a natural part of your site’s workflow.

Keep Your Research Compliant and Worry-Free

Schedule a call with our team to learn how SAON can simplify regulatory compliance and give you peace of mind with every study you conduct.