Clinical Quality Assurance

An exceptional Project Management approach lays the foundation for every successful clinical trial. And by successful, we mean more than just completing the project on-time and on-budget. At Theorem Clinical Research, we also focus on exceeding your expectations through a better way of doing business.

Our global CQA experts take pride in ensuring accuracy and efficiency throughout every aspect of your clinical trial. Our approach to quality assurance (QA) is one that demonstrates our commitment to positive outcomes.

• Flexible Structure. Because our CQA team operates as an independent business unit, we also conduct internal compliance audits throughout a lifetime of a study and across all functions. You’ll receive a comprehensive report for all contracted CQA services, where findings are listed clearly and concisely—including practical recommendations for issue resolution and recommendations for preventive actions.
• Quality People. Our CQA team takes a personal approach to the process, interacting with both operational staff and management to resolve potential challenges. Our expertise spans a variety of therapeutic areas and a vast array of CQA services. Our CQA department and all our European auditors fulfil the stringent requirements for auditors required by the Italian Decree 279, effective 26 Feb 2009.
• Proactive Solutions. Services include different activities designed to ensure success:
  • Audits
  • Process assessments
  • Trending databases of audit findings
  • Risk assessment of audit and inspection findings, as well as evaluation of implications for overall project quality
  • Development of Corrective and Preventive Actions (CAPA)
  • Comprehensive training
  • Facilitating Standard Operating Procedures (SOPs) and Guideline Development
• One Point of Contact. One CQA Project Leader serves as the primary contact for all QA issues throughout the life of the study. Your Project Leader coordinates all CQA activities and conducts most audits. CQA project leads also develop the Quality Plan, which details the scope, content and timelines of each audit and is agreed upon by CQA, the Project Director and you.
• Global Approach. Recognizing the global nature of compliance, our CQA professionals are multi-lingual—enabling rapid mobilization of our resources. We also have extensive experience in global Good Clinical Practice (GCP) guidelines. Located around the world, the Theorem Clinical Research team puts universal CQA best practices to work for you.