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Bioequivalence/Bioavailability

Design and conduct of clinical trials.
Bioequivalence/Bioavailability.
pharmacokinetic interaction of new combinations.
Design, writing, and revision of protocols.

Phase

Design and conduct of clinical trials.
clinical trials in phase I, II, III, and IV.
coordination of studies (Phase I, II, III, and IV).
Monitoring of clinical trials.
Writing, designing, and reviewing protocols.

Pharmacovigilance

Development of risk management plan (RMP).
Development of protocols for pharmacovigilance studies.
Monitoring for pharmacovigilance studies.”

Monitoring

Monitoring of Bioequivalence clinical stage studies.
Monitoring of Bioequivalence analytical stage studies.
Monitoring of phase clinical studies.

OTHER SERVICES

Compliance audit with GCPs at clinical research sites.
Training and development of procedures at clinical research sites.

WELCOME

The Mexican Association for Clinical Research, A.C. (AMIC) is an institution dedicated to conducting comparative bioavailability clinical studies (bioequivalence), as well as phases I, II, III, and IV.

Located in the city of Pachuca, Hidalgo, it was created in response to the need for a clinical unit to provide research services for the Development of New Medicines in Mexico for the National and International pharmaceutical industry, complying with regulatory, ethical, and quality requirements for the scientific growth of the country and the health of the population.

In 2023, AMIC celebrated its 35th anniversary, and we are proud to be pioneers in Mexico and Latin America, offering research services such as designing and conducting clinical studies and comprehensive clinical research consultancy. AMIC is comprised of an interdisciplinary team with extensive experience in carrying out its activities within the company. This team includes doctors trained in Japan, USA, Argentina, Brazil, and England with over 20 years of experience in clinical research and postgraduate studies, as well as nursing staff with up to 35 years of experience in clinical research. Together with other professionals, they work under a Quality Management System based on the ISO 9001:2015 standard and strict adherence to Good Clinical Practices.

+ 35

YEARS OF EXPERIENCE

+ 100

STUDIES

+ 200

CUSTOMERS

MEXICAN ASSOCIATION FOR CLINICAL RESEARCH A.C.

AMIC holds Authorization No. TA-73-21 to conduct bioequivalence studies (currently under extension). This service includes study design, drafting the research protocol, informed consent, case report forms, conducting the clinical study, up to delivering medical reports, final report, and the Final Safety Report of the study.

MEXICAN ASSOCIATION FOR CLINICAL RESEARCH A.C..

AMIC holds Authorization No. TA-73-21 to conduct bioequivalence studies (currently under extension). This service includes study design, drafting the research protocol, informed consent, case report forms, conducting the clinical study, up to delivering medical reports, final report, and the Final Safety Report of the study.


PARTICIPATE IN A STUDY

What do you need to participate?

This varies depending on the type of study:

  • Bioequivalence/Bioavailability
  • Conducting phase clinical studies

For studies involving healthy subjects, typically, some requirements must be met, such as:

– Being between 18 and 55 years old
– Presenting a valid ID (INE credential or passport)
– Being able to read and write
– Having a proportional weight to height
– Not smoking or consuming excessive alcohol
– Not using drugs
– Not suffering from any chronic illness (high blood pressure, diabetes, gout, high cholesterol, anemia, etc.)
– Not currently undergoing treatment with any medication
-Being available and having time to participate in the study

PARTICIPA EN UN ESTUDIO

¿Qué requieres para poder participar?

Esto varía, depende del tipo de estudio de que se trate:

  • Bioequivalencia/biodisponibilidad
  • Conducción de estudios clínicos de fase

Para los estudios en los que participan sujetos sanos, generalmente se deben cumplir algunos requisitos como son:

– Ser mayor de 18 años y menor de 55 años
– Presentar credencial del INE o pasaporte
– Saber leer y escribir
– Tener un peso proporcional a la estatura
– No fumar ni ingerir bebidas alcohólicas en exceso
– No consumir drogas
– No padecer ninguna enfermedad crónica (presión alta, diabetes, gota, colesterol alto, anemia, etc.)
– No estar actualmente bajo tratamiento con algún medicamento
– Tener disposición y tiempo para participar en el estudio

WE HAVE CUTTING-EDGE TECHNOLOGY

Us

We have excellent facilities to provide the best service.

Procedures

We carry out all our procedures with an excellent standard of quality.

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