Research

Dana-Farber Cancer Institute has a longstanding commitment to patient safety by ensuring high quality cellular therapy (CT) programs. As part of this commitment, there are several Quality Assurance teams, and each is charged with ensuring program success from a specific perspective: donor related, product related, and clinical treatment related. The combined efforts of these teams ensure quality and ongoing compliance to the highest of standards for cellular therapy programs.

In keeping with those industry standards, our CTQA teams maintain independent reporting structures. This means that, because of independent reporting, everything we do is transparent and intended to ensure the very best cellular therapy services, products, and clinical trials for patients.

About the Cellular Therapy Quality Assurance (CTQA) Teams

The Cellular Therapies Quality Assurance teams are a central resource for clinicians, researchers, and other staff — both at Dana-Farber and across all of our Harvard affiliates — for:

Quality Assurance and Regulatory Compliance

• Performing internal and external audits to ensure that Dana-Farber and its contracted services and suppliers operate in compliance with established policies, procedures and standards
• Auditing departmental practices and instituting corrective action when needed
• Ensuring that Dana-Farber is always in a state of inspection readiness and compliance with all policies and regulations

Quality Improvement (QI)

• Improving patient care
• Ensuring patient safety
• Enhancing patient satisfaction
• Reducing unnecessary testing and readmissions
• Improving workflow
• Reducing costs

Regulatory Affairs

• Actively involved, both across Dana-Farber and nationwide, in shaping the regulatory field for cellular therapy
• Helping Dana-Farber investigators gain clearance for clinical trials using novel cellular therapy products
• Conversing with the U.S. Food and Drug Administration about the challenges of fitting cellular therapy manufacturing into the regulatory pharmaceutical environment
• Ensuring Dana-Farber's status as one of the first centers registered as a Human Cell and Tissue Product Establishment when federal regulations changed

Data Capture and Analysis

• Capturing data from various cellular therapy programs and clinical trials engaged in services for patients
• Benchmarking certain data against internal standards and national standards
• Reporting other data to external agencies to ensure quality and establish ongoing quality improvement measures in the field of cellular therapy