Biorasi Receives ISO 9001:2015 Certification for Quality Management

Biorasi, a leading global full-service contract research organization (CRO), is proud to announce the achievement of ISO 9001:2015 certification. By earning this ISO accreditation, Biorasi has demonstrated dedication to the practice of quality assurance within the clinical trials industry and commitment to quality excellence for individual clinical studies.

“ISO 9001:2015 certification is a big deal for Biorasi,” said Chris O’Brien, CEO at Biorasi. “It is a powerful, independent validation of the quality of our processes. It sends a message to potential sponsors across the globe that Biorasi cares deeply about quality. It tells them they can trust us.”

Biorasi was presented with their ISO 9001:2015 certification on May 5, 2021, joining the ranks of other quality-focused organizations, including our preferred vendor, IBM Watson Health.

“Our Quality Policy is driven by the fundamental understanding that patients and their families are affected by the decisions we make,” said Todd Brill, VP of Regulatory Affairs, Clinical and Quality Assurance at IBM. “We are proud of our ISO 9001 certification and the level of quality it ensures for our products and our clients. We congratulate Biorasi for attaining their own ISO 9001:2015 certification – this exemplifies the dedication and partnership of both organizations to quality research and clinical trial execution.”

First published by the International Organization of Standardization (ISO) in 1987, ISO 9001 is defined as the global standard for quality management requirements. International organizations adhere to the ISO 9001 standard to organize and continually improve business processes and efficiency.

“Our ISO 9000:2015 certification speaks to the importance of quality assurance at all levels within the Biorasi organization,” said Mamta Hunt, VP of Quality and Pharmacovigilance at Biorasi. “It ensures a robust customer experience that focuses on areas of key significance to our sponsors while maintaining compliance and consistency across the life of the clinical trial. ISO 9000:2015 certification is an important step on our continuing quality journey.”

About Biorasi

Biorasi is a customer-focused, full-service, contract research organization (CRO) that delivers fast and flexible solutions across global clinical trials to maximize speed-to-market for its sponsors. As the leader in neurology, nephrology, dermatology, and the rare and urgent disease market, Biorasi sets new benchmarks for speed, agility, and quality in patient enrollment, decentralized trials, and data transparency. Contact Biorasi at info@biorasi.com / (786) 388-0700.

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Contact information

Media Contact:
Adam Gottlieb
(954) 410-3654
agottlieb@biorasi.com