HAVANA, Cuba, May 3 (ACN) The National Coordinating Center for Clinical Trials (CENCEC) strives to keep complying with the Good Clinical Practices and to maintain its certification of its Quality Management System, in accordance with the requirements of the ISO 9001 Standard, a status it has held since 2008, granted by the National Bureau of Standards and AENOR International.
Sandra Álvarez Guerra, a Doctor of Pharmaceutical Sciences and Master of Clinical Pharmacy who heads the Quality Management Department, told ACN that both distinctions give CENCEC visibility and international recognition and highlight its efforts to maximize customer satisfaction, namely that of the Cuban biopharmaceutical industry.
“In 2017, after the renewal audit based on the latest version of the ISO 9001 Standard, CENCEC became the first Cuban health center to meet the new requirements and fulfill the transition. And in 2020, during the COVID-19 pandemic and while other centers fail to maintain compliance, CENCEC managed to renew its certificate.”
Established in 1991, this institution has watched over the quality of all trials at national level and guaranteed compliance with good clinical practices.
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