Embracing Quality as a Culture: A Roadmap for Maintaining CRO Oversight
February 20, 2024
2:30 p.m.

In the clinical research industry, where patient safety and regulatory compliance are paramount, quality oversight is essential to success. Although the thorough vetting and qualification of a clinical research organization (CRO) is an important step, it’s just one of the many elements required to drive continuous improvement throughout the product development lifecycle.

This session will focus on strategies for establishing and maintaining quality oversight over a CRO, including the key trigger points for reassessment, tips for ensuring audit readiness across multiple stakeholders, and the nuances of global regulations that must be carefully considered and managed to ensure compliance.

Meet The Speakers

Theodora (Theo) O’Brien
Vice President, Corporate Quality, Premier Research

Theodora O’Brien is Vice President, Corporate Quality for Premier Research, where she is responsible for driving and promoting a ‘Quality Ethos’ throughout the organization. This includes establishing, implementing, and maintaining processes that comply with applicable laws, regulations, Standard Operating Procedures, protocols, and guidelines. Theodora is also responsible for coordinating and managing GxP and vendor audits globally and provides extensive support in the analysis and streamlining of operational SOP’s and procedures.

Theodora holds an MSc Business and Management and BSc Biomedical Science from the University of Portsmouth, and is a certified ISO 13485/9001 QMS Lead Auditor for Medical Devices

Arbab Anwar
Senior Auditor, Inspection
Corporate Quality, Premier Research

Arbab Anwar is a Senior Auditor within Corporate Quality at Premier Research where he is responsible for supporting and managing regulatory inspections at the company, sponsor, and investigator site level. This includes promoting a state of inspection-readiness at all times as well as supporting the implementation of solutions for observations identified during inspections to ensure compliance with GXPs, study protocols, and applicable regulations.

Arbab holds a BSc Chemistry degree from the University of Surrey and has over 10 years’ experience working in Quality Assurance within a GLP, GMP, GDP and GCP framework. This includes working in the pharmaceutical, biotech and medical device industries on QMS management, supplier management, internal/external auditing, continuous improvement, QA project work and risk management.