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.