The foundation of quality at RadMD is based upon the following guiding principles and practices:
Senior management engagement
Management Commitment is the cornerstone of all quality practices. The RadMD senior management are actively engaged in all aspects of product and service provision and are the drivers of excellence within the organization.
Excellence in staffing
RadMD is committed to maintaining a staff of qualified, trained, and capable team members to consistently provide excellent customer service. All team members are provided complete training materials, processes, and procedures to perform their assigned roles and responsibilities. RadMD senior management is engaged in the hiring, training, and advancing team members and supporting their interactions with study teams.
The RadMD process of selecting clinical experts ensures the most appropriate medical professionals are chosen for blinded reads and other clinical trial-related activities to support each study and minimizes any potential bias that could occur should sponsors or ICRO’s directly engage blinded readers.
Quality procedures
Quality procedures are essential to ensuring consistent practices are followed, and standards are documented and effective. To that purpose RadMD has established a suite of Standard Operating Procedures governing compliance with applicable clinical trial regulations for the qualification of personnel, controls for regulated documents and records, security, privacy, and quality checkpoints.
Regulatory commitment
RadMD is committed to operating in accordance with global regulatory frameworks and industry best practices. Our role in clinical trials is essential to the success of our clients and we adhere to all rules, regulations, and best practices for clinical trials, imaging, data protection, and data privacy. RadMD policies and practices are governed by the following regulations, laws, and principles:
- ICH E6 r2 (Good Clinical Practice)
- US Health Insurance Portability and Accountability Act (HIPAA)
- US 21 CFR 11 – Electronic Records & Signatures
- US 21 CFR 50 – Protection of Human Subjects
- US 21 CFR 54 – Financial Disclosure
- US 21 CFR 56 – Institutional Review Boards
- US 21 CFR 812 – Investigational Device Exemptions
- US 21 CFR 814 – Premarket Approval of Medical Devices
- EU GDPR (General Data Protection Regulation)
No findings at our most recent FDA audit in March 2021.