Clinical studies
Phase I
Clinical Studies
Phase II
Clinical Studies
Phase III
Clinical Studies
Phase IV
Clinical Studies
Phase I
Determine the safety and dose of new drugs; which are usually performed on a small number of subjects and are completed in a short time, usually one month.
Phase II
Evaluate the new drug’s efficacy for the treatment of the disease, as well as its side effects; this requires the participation of hundreds of subjects and it is usually carried out at several research centers simultaneously, in several countries.
Phase III
Confirm the effectiveness and long-term effects; usually, thousands of patients are required and the studies are performed in several countries simultaneously; at the end of this phase, the new drugs are submitted to the health authorities (in Mexico to COFEPRIS) for approval and subsequent commercialization.
Phase IV
Clinical trials performed after the release of the drug to the general population: efficacy and safety data are evaluated from thousands of patients.
Patients recruitment
Our geographic location, collaboration agreements, and access roads allow the metropolitan area's population as well as residents of different municipalities to participate in the research projects.
Clinical setting management
We have a network of researchers, research centers, and clinical study laboratories across the country.
Using our regulatory expertise in order to successfully collaborate with pharmaceutical and biotech companies, academic institutions, governments, and public health organizations.
Data Management
Carrying out clinical research studies allows us to generate reliable and traceable data, to support clinical safety, therapeutic efficacy and the risk-benefit analysis.
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Following the standards established by the ICH (International Conference on Harmonization) in order to achieve validity and recognition of the scientific information generated by our solutions.
Clinical monitoring
The accuracy and traceability are ensure of the data obtained from the development of clinical studies through our collaboration agreement with other Contract Research Organizations (CROs).
Clinical Writing & Documentation
Every protocol drafting is homologate to international standards and guidelines. We align our clients’ objectives with the best study design and regulatory standards.
Pharmacovigilance
The research cycle of drugs or medical devices continues even after regulatory approval. At CIMeT we support companies with pharmacovigilance solutions.