In the clinical research industry, where patient safety, data integrity and regulatory compliance are paramount, quality oversight is essential to success. As clinical trial complexity increases, so does the pressure on sponsors and contract research organizations (CROs) to improve efficiency while maintaining quality.
For sponsors, thorough vetting and qualification of a CRO is critical to building quality into clinical trials at the outset. However, CRO selection is just the first of many activities necessary for driving continuous improvement throughout the product development lifecycle. Putting in place robust processes for effective, ongoing CRO oversight enables sponsors to uphold their responsibility for trial conduct and quality and optimizes the likelihood of study success.
In this webinar, the expert speaker will explore strategies for establishing and maintaining quality oversight over a CRO, from vendor selection to performance measurement.
Register for this webinar today to understand effective strategies for ensuring effective CRO oversight and obtaining continuous quality improvement throughout the clinical trial process.
Speaker
Theodora (Theo) O’Brien, Vice President, Global Quality, Premier Research
Theodora O’Brien is Vice President, Global 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 operations procedures (SOPs), 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 SOPs and procedures.
Theodora holds an MSc in Business and Management BSc in Biomedical Science from the University of Portsmouth and is a certified ISO 13485/9001 QMS Lead Auditor for Medical Devices.
Message PresenterWho Should Attend?
This webinar will benefit Managers and above at biotech and specialty pharma companies with job functions including but not limited to:
- Quality management and assurance
- Clinical operations
- Project management
- Regulatory and medical affairs
What You Will Learn
Attendees will learn about:
- Key components to monitor in CRO and vendor oversight
- Review of ISO and ICH guidelines, including expectations for ICH E6(R3)
- Tips for maximizing audit and inspection readiness
- Nuances of ensuring compliance with global regulations
Xtalks Partner
Premier Research
Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier–research.com.
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