Quality Assurance, Monitoring and Regulatory Affairs

SCCR is committed to conducting and supporting high-quality, compliant clinical research. We employ a Quality by Design strategy, underpinned by a specialized team with vast experience in Quality and Compliance. This team’s expertise is instrumental in supporting all SCCR clinical research activities, enhancing safety and well-being of participants, and integrity of the research.

We maintain streamlined, efficient operations based on our catalog of Standard Operating Procedures, and operational practices compliant with local policies, regulatory requirements and international guidelines.

In accordance with the principles of Good Clinical Practice, our SCCR Quality Management System focuses on four core areas:

• • Risk Management
  • Evidence-Based Operations
  • Quality Improvement
  • Quality Control/Quality Assurance

These tenets are promoted through various methods including use of a project-specific, risk-based approach to identify quality and compliance-related activities, and employing evidence-based operations such as continuous monitoring and evaluation of plans to ensure effectiveness. Methods also include ongoing process improvements deployed at the study, program and organizational level, along with deploying systems such as the SCCR Quality Incident Management (Corrective Action & Preventive Action) system to capture and analyze quality incidents.

Monitoring

The SCCR Monitoring Program provides oversight for the conduct of clinical research. The fundamental goals for the program are to ensure:

• • Protection of participant’s rights
  • Protocol compliance
  • Accuracy and completeness of trial data

We provide comprehensive monitoring support through a team with skills and expertise in:

• • On-site, remote and hybrid monitoring
  • Conducting risk assessments at the study and site level
  • Providing 100% Targeted or Risk-Based monitoring
  • A variety of therapeutic areas and intervention modalities

Quality Assurance

Quality assurance (QA) is a systematic process that ensures the quality of the clinical trial and the data it generates. QA activities include regular reviews performed to ensure adherence to regulations and Good Clinical Practice guidelines. QA staff are independent from the research team to ensure objectivity and impartiality in the evaluation of the research conduct.

The SCCR QA team is responsible for creation and maintenance of SCCR SOPs, Guidance Documents, Policies, and Work Templates.

The SCCR QA team capabilities include:

• • Preparation for FDA inspections and external party audits
  • Conduct of study, investigative site and study vendor audits
  • Providing advice on interpretation of compliance regulations, and guidance on how to assess and address research compliance issues
  • Tracking and assessing clinical research quality incidents utilizing the SCCR Quality Incident Reporting System

Regulatory Affairs

The SCCR Regulatory Affairs team is proficient in liaising with the US FDA, including correspondence, and application submission and management in accordance with the regulations. The Regulatory Affairs team also provides guidance on Institutional Review Board submissions, IRB annual renewals, and the Sponsor Investigator Research Process.

Regulatory application expertise:

• • Investigational Device Exemption
  • Investigational New Drug
  • 510K Submissions
  • Premarket Notifications
  • Biologics License Application and Biosimilars
  • Orphan and Rare Disease Designation

 Relevant Accomplishments 2023-2024