A Practical Approach and Framework to Quality Management for Smaller Sponsor Companies
Dawn Lundin
ABSTRACT
Sponsor companies engaged in clinical trials are to design quality into clinical studies upfront as outlined in ICH E8 R1, General Considerations for Clinical Studies, and ICH E6 R3, Guideline for Good Clinical Practice. The establishment of core quality management system elements and identification of what is critical to quality should be done as early as possible to facilitate the assessment of risks to participants and data integrity. Sponsors should develop systems to manage quality throughout all stages of the trial process, in accordance with regulations and ICH E6 R3, and ensure that oversight is commensurate with the risks associated with the clinical development programs to support informed decision-making. Quality system core elements should be established to facilitate compliance, be flexible enough to accommodate shifting priorities, and mature to scale with growth. For smaller start-ups or mid-size organizations, the same requirements apply as they would for the research and development of any other drug, biologic, or device developed by large pharmaceutical companies. Funding campaigns should include quality management related costs as early as possible to enable regulatory compliance.
