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Analysis

Certification Brings More Clinical Trials

Wed, 09/09/2015 - 12:29

In 2012, The Mexico City Campus at Tecnológico de Monterrey announced a two-year project to assist 40 clinical research sites in becoming certified to ISO 9001, the global standard for quality management. In collaboration with the Competitiveness and Innovation Program (PROCEI) and the European Commission, the aim of the program was the training and certification of 40 Mexican small and medium enterprises (SMEs) that conduct clinical studies. The clinical trials industry in Mexico is expanding, and more collaboration among key players is necessary to promote further development. Working for the professionalization of clinical research and improving the quality of knowledge possessed by all actors in the industry will ideally position Mexico as an attractive investment opportunity for more multinational clinical trials and aid the country to become a clinical research hub in the Latin American region.

The project began with the concept of developing an innovative quality model for clinical research centers. International regulations as well as the Good Clinical Practice (GCP) standards were reviewed to incorporate the best requirements and recommendations into the model. Subsequently, several SMEs were contacted to participate in the project, selected according to their experience, knowledge and technological capabilities. According to the Project Leader, Dr. Dora Carranza, Director of the Clinical Research Unit of Tecnológico de Monterrey, Mexico City Campus, one of the biggest challenges was transforming investigator mindsets from an exclusive focus on patient care to the acknowledgement of the research units as businesses, requiring a business strategy, quality policy and standard procedures.

The Mexico City Campus of the University undertook training of staff from the 40 research centers through courses and direct consultancy services over the course of more than two years. Developing and implementing a quality management system enables companies to increase customer satisfaction by process control and monitoring. In the clinical trials field, both patients and multinational companies are clinical site customers, so not only must high quality sites comply with GCP and regulatory requirements, but also prove capabilities in quality planning, strategic allocation of resources, evaluation of suppliers, personnel training and documentation, all of which must be specified in a standardized procedures manual. Employment of such protocols ensures that patient safety is guaranteed and customer requirements are met. An authorized company accredited the research centers to ISO 9001 standards.

According to Dr. Victor Belalcazar, Director of Icaro, one of the clinical research centers that earned the certification, “there is nothing more important than improving quality as a means to increasing competitiveness.” Yolanda Cervantes, Clinical R&D and Medical Affairs Vaccines Director at GlaxoSmithKline Mexico, said that more research centers are expected to join this initiative and become part of the collective drive for quality that Mexico is experiencing. Similarly, Francisco García Zetina, Executive Director of Products and Establishments Approval of COFEPRIS, stated that certified clinical research centers will undergo less regulatory scrutiny, although by its very nature the requirements are constantly adapting to prevent compromise of patient security.

Regarding clinical research in other Latin American countries, Humberto Reynales, CEO of the Center of Attention and Medical Investigation (CAIMED) and President of the Colombian Association of Clinical Research Centers (ACIC), described a norm requiring Colombian research centers to be certified by the Colombian regulatory agency INVIMA. ACIC enforces several protocols such as ethics committee improvement and training for researchers. Furthermore, he highlighted the importance of developing a collaborative network in Latin America for strengthening the clinical trials industry in the region, while applauding the already high standard of clinical research professionals and quality practices.

The 40 SMEs are located throughout the Mexican territory and the next step in the training process is to build a network of certified quality centers with the aim of consolidating their presence in the industry and working with related associations, such as the Alliance of CROs in Mexico (ACROM) and the Mexican Association of Investigative Pharmaceutical Industries (AMIIF). Investment in the clinical trials industry in Mexico could prove prudent since Mexico has a large untreated patient pool, a high prevalence of a variety of chronic degenerative diseases, and an array of highly qualified professionals. Moreover, the country’s geographical proximity to the US and other Latin American countries has created a strategic advantage. Mexico has proved to be able to conduct high quality clinical trials through exemplary audits and inspections results, and recently COFEPRIS developed a pre-authorization process in which nine Institutes of Health can review and pre-authorize study protocols within 20 days. While Mexico continues to develop its R&D capabilities, hosting more clinical trials becomes a catalyst for the creation of jobs, as well as representing a therapeutic alternative for patients.