Our services

In the Clinical Research Unit
CLINICAL STUDY DESIGNS
  • Advice on the design of clinical trials, taking into account the different parameters required by the sponsor, researcher and / or the client; so that the study meets each of the methodological, statistical and regulatory requirements.
ADVICE ON REGULATORY MATTERS
  • Generation, adjustment and / or review of the necessary documentation for the approval and authorization of clinical studies by committees and regulatory entities.
RECRUITMENT OF STUDY SUBJECTS
  • We have collaboration agreements with public and private institutions, as well as a wide network of referring physicians for the recruitment of study subjects.
PROTOCOL EXECUTION
  • We carry out clinical protocols for the study of drugs, biomedical and biological devices in the ophthalmology area, always safeguarding the integrity and rights of the patient, as well as their adherence to the clinical trial.

Clinical Research Unit

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Our unit specializes in clinical research in ophthalmology and we are members of the Mexican Association of Clinical Research Centers (AMCIC). We have a National Registry of Scientific and Technological Institutions and Companies (RENIECyT); ISO 9001 certification since 2015 and currently certified with the latest update to ISO 9001: 2015.

Our clinical site is linked to the hospital environment of the Medical and Surgical Retina Center and the Puerta de Hierro Hospital, with agreements for compliance with the requirements of COFEPRIS for the care of medical emergencies, clinical studies laboratory, among others.

The Medical and Surgical Retina Center to which we are linked has various recognitions and accreditations such as Jalisco Quality Award 2010, National Quality Award 2011, Iberoamerican Quality Award 2012, National Technology and Innovation Award 2015 and Certification in force by the General Health Council.

Our Quality Management System has allowed us to work with internationally recognized companies for the generation of innovative drugs and medical devices, positioning us as pioneers in clinical trials in their multiple phases, such as:

  • ARGUS II, with the company Second Sight Inc. Also known as “bionic eye” or “retina implant,” is the first artificial vision retina prosthesis system approved to restore vision in people who are blind.
  • Likewise, clinical research was developed with Opko Health for the generation of a nanotechnology-based system for the topical administration of drugs aimed at treating diseases that affect the retina (avoid intraocular injections)
  • Development of encapsulated cell technology for the treatment of age-related macular degeneration, in conjunction with the American company Neurotech Inc.
  • Implantable ophthalmic micropumps, a biomedical-micro-electro-mechanical system (BIOMEM) for sustained intraocular drug delivery with the company Replenish Inc.

QUALITY POLITICS

Conducting clinical studies in ophthalmology with adherence to regulatory, ethical, and technological aspects, complying with the requirements of our clients and with the regulatory, quality, and safety standards of the organization’s own stakeholders.

CONDUCT OF CLINICAL PROTOCOLS

Our clinical research unit is certified in ISO 9001: 2015, comprising the processes of “Negotiation of the clinical study; Selection and recruitment of subjects for the execution of the protocol based on the requirements as a clinical research unit” that considers the context and the interested parties of the organization.

QUALITY OBJECTIVES

1. Recruitment: Comply with at least 95% of the number of participating individuals as voluntary subjects, in the time agreed with our clients.

2. Attachment to the patient: Maintain the percentage of patient attendance, in events that include the clinical study, greater than 90%.

3. Deviations: Have no more than 5% deviations from the protocol based on the requirements established by the client.

4. Protocol Recruitment Time: Reduce protocol recruitment time by 5% to that established by the client.

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We collaborate with both companies and researchers to successfully develop clinical protocols.

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