Our Services

At Quality Research Solutions, we offer a comprehensive suite of services designed to elevate clinical research site performance and ensure regulatory excellence. Our core offerings include detailed data review and quality control processes to identify and resolve discrepancies before they become compliance risks. We also provide third-party auditing services, offering an objective, expert perspective to assess site readiness for sponsor or regulatory inspections. Our team conducts in-depth SOP reviews, ensuring that all procedures align with current GCP standards and reflect best practices in clinical operations. Additionally, we deliver targeted regulatory compliance training tailored to site staff roles, equipping teams with the knowledge and confidence to maintain continuous inspection readiness. Each service is tailored to help sites operate at the highest standards of quality and integrity.

Data Review

Our data review services provide a thorough, line-by-line evaluation of clinical trial source documents, case report forms, and regulatory files to ensure accuracy, completeness, and compliance with protocol and regulatory standards. We identify discrepancies, trends, and potential risks early, allowing for timely corrective actions and stronger data integrity throughout the study lifecycle.

Third Party Audits

Our third-party audit services offer an independent, expert assessment of your site’s compliance with GCP, protocol requirements, and regulatory expectations. We simulate sponsor or regulatory inspections, identify gaps, and provide actionable recommendations to strengthen your quality systems and ensure audit readiness.

SOP Review/Development

Our SOP development services are designed to help clinical research sites establish clear, compliant, and practical standard operating procedures that align with current GCP guidelines and regulatory requirements. We work closely with your team to create or revise SOPs that reflect your site’s unique workflows while ensuring consistency, accountability, and audit readiness.

Regulatory Compliance Training

Our regulatory compliance training services equip clinical research site staff with the knowledge and skills needed to confidently navigate FDA, GCP, and ICH regulatory requirements. We offer tailored training sessions—both in-person and virtual—focused on real-world application, inspection preparedness, documentation standards, protocol adherence, and common audit findings.

Our Packages

We offer flexible service options to meet the unique needs of clinical research sites, including both comprehensive support packages and a la carte services. Our packages provide ongoing, proactive quality oversight—ideal for sites seeking consistent regulatory and compliance support—while our a la carte offerings allow for targeted assistance such as data review, audits, SOP development, or staff training. Whether you need a long-term partner or support for a specific project, our services are designed to enhance compliance, efficiency, and inspection readiness at every stage.

Recurring Data Audits

Our services include recurring audits to ensure ongoing data quality, regulatory compliance, and early detection of issues before they become findings.

Annual Training

We provide annual regulatory compliance training to keep your site staff current with evolving guidelines and inspection expectations.

Quality Project Completion

We also support single, a la carte projects such as focused data reviews and SOP development to meet immediate compliance needs or prepare for upcoming audits.

Get a Quote

Contact our team to see how we can support your site with audit & regulatory readiness!