OC-14: IMPACT OF QUALITY SYSTEM FOR CLINICAL TRIALS WITH NATURAL PRODUCTS

J Pharm Pharmacogn Res 3(suppl. 1): S32, 2015

Proceedings of the 4th International Symposium on Pharmacology of Natural Products FAPRONATURA 2015  September 21st-25th, 2015; Cuban Society of Pharmacology. Topes de Collantes, Sancti Spiritus, Cuba.

Oral Communication

OC-14: IMPACT OF QUALITY SYSTEM FOR CLINICAL TRIALS WITH NATURAL PRODUCTS

Álvarez S.

National Center Coordinating of Clinical Trials (CENCEC), Ave. 5th A e/ 60 y 62 Miramar, Playa. CP 11300. Havana, Cuba. E-mail: sandra@cencec.sld.cu, salvarez@infomed.sld.cu

 

The National Center Coordinating of Clinical Trials, contract research center, for the design and conduct of clinical trials on investigational products natural or not, fulfilling the requirements of Good Clinical Practice (GCP), did not have a Quality Management System (QMS) that would raise the quality of their services, and indicators to measure the effectiveness of its processes. This led to design a QMS according to requirements of the NC-ISO 9001, for the clinical trials process developed in the CENCEC applying the GCP. The QMS is structured in stages, “Exploratory or diagnostic”, “Development of intervention actions and implementation” and “Evaluation”. With QMS twelve barriers to implementation were eliminated. Documentary system according to ISO 9001 was established, was prepared to human capital and tools for continuous improvement is built was established. A system with 38 indicators that measured the effectiveness of key strategic and support processes complied. The evaluation showed that the system is properly implemented, backed by customer satisfaction, performance indicators and the results of external audits. The implanted QMS raised the quality of services and was certified to comply with the requirements of the NC-ISO 9001, becoming the first contract research center in the third world with the condition.

 

Citation Format: Álvarez S (2015) Impact of quality system for clinical trials with natural products. [Abstract]. In: Proceedings of the FAPRONATURA 2015; 2015 Sep 21-25; Topes de Collantes, Sancti Spiritus: CSF. J Pharm Pharmacogn Res 3(Suppl. 1): S32. Abstract nr OC-14.