Quality Oversight: The Key to Optimizing Your Clinical Trial During COVID-19
During times of increased urgency for market-ready products, including the development of COVID-19 vaccines, the value of comprehensive Quality Oversight (QO) becomes even greater. This is underscored by the FDA’s mandate for all sponsors to validate the work of their CRO’s and ensure the integrity of their clinical trial data and rigor of the scientific process. This is where the Beaufort team can help.
Beaufort’s QO team are true innovators of this critically-needed service. Our comprehensive QO solutions provide an independent perspective that helps sponsors keep their commitment to developing products in accordance with the highest regulatory standards. As all businesses are adapting to the impact of the pandemic, Beaufort has continued to take the lead as our specialized teams are providing both remote and on-site QO services for a Phase 3 COVID-19 vaccine clinical trial.
Pioneering Innovation in Quality Oversight
Beaufort is proud to be the first to develop an independent Quality Oversight program to help sponsors objectively assess and improve CRO and site performance. We have worked with leading global sponsors and delivered a quantifiable approach to assessing data, processes and performance while optimizing the effectiveness and efficiency of their trials.
See how a global pharmaceutical company in need of Quality Oversight for a pivotal Phase 3 trial benefited from our services. Read
The Value of Independent Quality Oversight
Why should you outsource your QO needs to Beaufort? Our dedicated QO team are experts in critically assessing and providing unbiased feedback that results in opportunities for early process improvement and cost and time savings. We also provide:
- Third-party assurance to regulatory agencies of your commitment to CRO oversight
- Independent assessments that eliminate any inherent biases that may exist
- Improved efficiencies and risk mitigation through co-monitoring
- Better adherence to trial plans to reduce non-regulatory compliance
- Real-time CAPA to prevent delays and reduce costs