Technical Resources International, Inc
The Quality Assurance (QA) Experts

Technical Resources International, Inc. (TRI), founded in 1979, has excelled at providing comprehensive Quality Assurance (QA) services for the private sector, government agencies, and nonprofit organizations. With TRI’s technical expertise, management experience, and operational framework, clinical trial sponsors can develop and review their own quality management programs to facilitate effective clinical research implementation, verify data accuracy, and promote a constant state of readiness for an external audit or regulatory inspection. TRI’s program activities include Quality Management Systems (QMS) Development; Auditing Services; Compliance Services, such as for 21 Code of Federal Regulation (CFR) Part 11 and 45 CFR 46, and International Organization for Standardization (ISO) certification readiness; Support Services for regulatory agency inspection readiness and enforcement action; and Validation Services. “Our Quality Assurance Department provides an effective, efficient QMS. We ensure compliance and good working practices with Good Practice Guidelines (GxP), and local, national, regional, and international regulatory requirements,” says Nora Lee, President and Chief Executive Officer (CEO) at Technical Resources International, Inc. (TRI).

By implementing a robust Risk Management Plan (RMP), TRI successfully mitigates risks before obstacles materialize. The RMP proactively outlines how risk management activities are performed throughout the project lifecycle. The plan also provides templates and practices for monitoring, recording, and prioritizing risks. Following the RMP, TRI addresses the high-probability, high-risk issues, controlling them with solutions based on years of hands-on experience. For example, given the current pandemic situation, actively mitigating risks such as staff attrition and travel restrictions of audits are critical. The company ensures sponsors’ clinical and scientific programs and processes meet all required procedures, controls, and applicable regulations related to clinical research.

Throughout its ongoing reviews, TRI provides and discusses with project and sponsor leadership recommendations for changes, including updates to processes, new procedures, adjustments to performance metrics, or software enhancements.

Our Quality Assurance Department provides an effective, efficient Quality Management System (QMS). We ensure compliance and good working practices with Good Practice Guidelines (GxP), and local, national, regional, and international regulatory requirements

“Our QA Services demonstrate leadership and commitment, customer focus, operational planning and control, ongoing performance evaluation, and continual improvement to support the highest standards of conformance to all regulatory requirements,” explains Lee.

TRI’s QA Department, which operates independently from other departments, comprises highly skilled QA experts who are Certified Quality Auditors (CQAs) experienced in working with regulatory authorities. With a 42-year successful track record of providing excellent services, TRI believes in growing organically. This strategy allows the company to offer clients customized, consistently high-quality, reliable services, ensuring milestones are always met, and expectations are often exceeded. “At TRI, we understand that one size does not fit all, especially when it comes to clinical research projects,” states Lee. Additionally, TRI provides a unique, unified strategy of service areas—Clinical, Technology, and Communication Services—all supported and enhanced by its Quality Assurance Services. As a result, the award-winning work TRI performs has a significant, meaningful impact on community at all levels—local, state, national, and international. “We ensure that public health, quality clinical research, and customer satisfaction are top priorities, and will remain so in the future,” concludes Lee.