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About us
About us
The Mexican Association for the Clinical Research (AMIC) is an institution dedicated to the performance of comparative bioavailability studies, as well as phases II, III, and IV.
Located in Pachuca, Hidalgo, it was created as a response to the need of having quality and ethic services for the pharmaceutical industry in compliance with the national and international regulations.
AMIC has 38 years of experience in the design, and conduction of clinical trials for the pharmaceutical industry in Mexico and abroad. Additionally, we offer integral consultancy on clinical research during all the stages. AMIC is formed by an interdisciplinary group with extensive experience on the design, and conduction of clinical research. The team comprises specialist physicians trained in Japan, USA, Argentina, Brazil and England with more than 15 years of experience on the clinical research; chemists with more than 15 years of experience; the nursing team with more than 20 years of experience; and other professionals working under a quality management system based on the standard ISO 9001:2015, and in strict compliance with the Good Clinical Practices.
Authorized third party
AMIC has the authorization number TA-26-18 to be able to perform bioequivalence studies.
This service includes the proposal of the clinical research, the research protocol design, the informed consent, the forms of the report of the case, and the delivery of the final, medical and pharmacovigilance reports.
For the execution of this service, AMIC has a healthy volunteer bank, as well as all document and regulatory support required by COFEPRIS.
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Vision
To be a highly competitive clinical research center recognized nationally and internationally for the excellence of the service.
Mission
To perform services related to the clinical research in order to contribute to the improvement of health in human beings with quality, profitability, efficiency and excellence of the service.
Values
Approach, enthusiasm, adaptability, competitiveness, integrity and professionalism.
Quality Policy
To perform studies on safety, efficiency, and bioavailability, among others services regarding clinical research, according to the current regulations and the Good Clinical Practices in an efficient quality management system that assured the compliance of the client’s needs, and the commitment in the continuous improvement of our services.
Quality Management System
AMIC establishes, implements, maintains, and improves continuously its Quality Management System, including the necessary procedures, and its interactions according to the requirements of the quality standard ISO 9001:2015 / NMX-CC-9001-IMNC-2015.
The performance of the clinical researches in AMIC is certified with the quality standard ISO 9001:2015.
The General Health Act is suitable for all 4 types of services offered by AMIC:
a. Performance of bioavailability and bioequivalence studies (including design of the documents for the study and conduction).
b. Conduction of phases I to IV of the study.
c. Coordination of clinical research studies (it may include design of the documents) performed in external clinical sites.
d. Consulting and training (including audits, monitoring, training on clinical research and general consulting).