Quality & Compliance

Quality Assurance

Quality Assurance oversees study deliverables and ensures our Standard Operating Procedures (SOPs) are followed and Regulatory compliance is achieved.

Canfield Quality Team

Our team's focus on quality is an integral part of every clinical project. We recognize the importance of quality during every stage of the study to provide every client with data that is credible, reliable, and in alignment with applicable Regulatory requirements. Canfield is committed to the most rigorous standards of project management, quality control and oversight. We ensure all the moving parts of a study are maintained with the study objectives always in mind.

Every client benefits from Canfield's commitment to quality and experience in disciplines including privacy of Protected Health Information, Regulatory process, clinical data management, and computerized system validation. Our independent Quality Assurance department reports directly to the company President and oversees:

  • GCP quality system development and compliance, including overall study-specific compliance
  • 21 CFR Part 11 compliance of Canfield systems, controls, and procedures
  • Compliance with European Directive on Data Protection and Safe Harbor Privacy Principles
  • Creation and review of Standard Operating Procedures (SOPs), standardized forms and templates, and study-specific procedural documents

The Quality Assurance Team facilitates continuous improvement through internal audits of Clinical Services departments and related study documentation to ensure consistent, defendable quality results.

Regulatory Support

Canfield Scientific provides a professional, personalized approach to our regulatory consulting services, management, and clinical study document review. Canfield’s established standard operating procedures assure adherence to Good Practices, and worldwide regulations.

We are experienced in managing, writing, reviewing, and compiling documentation including:

  • System Validation
  • Protocol Development
  • Clinical development plans
  • Informed consent documents
  • Audit Responses

Canfield frequently interfaces with its clients in supplying method validations, providing special projects support, and marketing assistance to help in many different aspects of their clinical trial process.

Consulting

Canfield has been in the clinical development process for 20 years. Our senior staff can provide protocol review, imaging protocol development, study design, marketing assistance, special project support, and method validation assistance. Each deliverable reflects the collaboration of our interdisciplinary team of Regulatory Affairs, Quality, Project Management, Clinical Data Management and Programming staff. From early-phase development through post marketing, we use a library of data tools, programs, and processes based on our foundation of experience to deliver a solution that meets your needs.