Our ISO 9001: 2015 certified clinical research unit has different services that support our mission and vision to be a center of excellence:
Clinical trial design
Advice on the transfer of basic research projects to clinical research
Advice and design of the first clinical trial in humans.
Advice and design of phase I, II, and III clinical trials.
Regulatory affairs management
We participate in the management of clinical trials in compliance with current Mexican regulations, which include documentation such as the clinical protocol, investigator’s manual, validly informed consent, among others.
Review and consulting service for submission for approval of clinical trial committees established by Mexican regulatory entities
Advice for the submission of protocols to the Federal Commission for Protection Against Health Risks (COFEPRIS) and follow-up until their approval
Compliance with Mexican regulations for the initiation, conduct, and closure of clinical protocol before the corresponding entities
Recruitment of subjects for clinical trials
Recruitment of patients for clinical trials in the ophthalmology area guaranteeing the inclusion and exclusion criteria determined in each trial to avoid the entry of non-candidate subjects (Screening failure).
Based on the signing of collaboration agreements, we have a wide network of referring medical specialists who actively participate in the process of identifying and recruiting participants effectively and efficiently.
Execution of clinical trials
We have specialized services to execute clinical ophthalmology protocols, which include drugs, biomedical and biological devices for the retina, vitreous, glaucoma, optic nerve, lens, cornea, and other structures of the eyeball.
The unit has adequate facilities and specialized equipment that are the gold standard:
Physical structure specially designed for the necessary evaluation of clinical trials
Imaging equipment of anterior and posterior segment of the eyeball for the evaluation and follow-up of clinical studies that have their maintenance and calibration required, includes the latest generation coherent optical tomography (Zeiss Cirrus 6000, Zeiss wide-field fundus camera Clarus 750, ocular ultrasound, slit lamps, among others.)
Collaboration agreements for the care of medical emergencies as they are in a hospital setting at the Puerta de Hierro Andares Hospital.
Various collaboration agreements that complement clinical trials such as, clinical analysis laboratory (Accredited in Good Laboratory Practices-IATA), radiology, blood bank, hospitalization, operating rooms, among others.
We have the parcel service for the transport and export of biological samples.
Patient adherence to ensure compliance of visits to the required tests of each clinical trial.
Generation of own documentation for each protocol.
Relationship with the organization’s monitor for the periodic review of the progress of the clinical study.
Protection of information
We have the ability to safeguard information with a minimum of 5 years established in Mexican regulations and for up to 20 years or more according to the needs of the client.
We collaborate with both companies and researchers to successfully develop clinical protocols.