Pharmacovigilance / Technovigilance

The use of any type of medication for treatment, diagnosis or therapy, implies the potential risk of presenting any adverse reaction or event in the user, considering this, the use of a medication is based on the risk-benefit ratio, it is That is, when the pattern of adverse events presented is tolerable compared to the therapeutic benefit it provides to the user. All medications are subjected to safety studies before they are marketed, these tests provide valuable information about the behavior of the medication and it is of utmost importance to continue with the process of detecting suspected adverse reactions once they are marketed to an open population.

Our pharmacovigilance unit

In INFINITE we integrate a pharmacovigilance unit with experience in the detection, identification, quantification, understanding and evaluation of adverse events and suspected adverse reactions that are presented in clinical studies and medications that are being marketed in the national territory and globally.

Pharmacovigilance is intended to monitor the safety of medications from their pharmaceutical development and throughout their life cycle. The various activities that are carried out include from the identification, evaluation and prevention of adverse events that may occur due to the use of the medicine.

The use of any medication has the potential to trigger adverse events regardless of whether they are used for therapeutic, diagnostic or treatment purposes or those medications that are in a development, research or manufacturing process with the highest quality standards, not forgetting that the use of a medicine is based on the risk / benefit ratio, that is, when the pattern of adverse events it presents is tolerable compared to the therapeutic benefit it provides.

Producing laboratories or their legal representatives have the responsibility of guaranteeing the quality, safety and efficacy of the medicines they sell in the country and the National Regulatory Authority (COFEPRIS) must verify this guarantee, as well as establish policies and guidelines in this matter, in concordance with international regulations.

Recognizing the need to detect adverse events, as well as notify them before the corresponding health authority, INFINITE considers priority the development of systems that allow the implementation of an efficient process for the reporting of individual cases of SRAM, RAM, ESAVI, EA and EAS * that occur at any time during the clinical study or life cycle of the medication.

INFINITE is committed to implementing quality pharmacovigilance systems in order to ensure the well-being and safety of the study subjects. We have the specialized staff to receive, evaluate, correlate, submit and follow up until the satisfactory resolution of your safety reports before the ethics committees and COFEPRIS through our accredited Pharmacovigilance unit to do so.

If you have an adverse event to report, have any questions or comments about the service provided by the INFINITE pharmacovigilance unit, please contact us.

To report an adverse event from the use of a medication and / or medical device, fill out the form at the bottom of this page.

To contact us please use the following methods

E-mail to

Telephone to the number +52 (55) 50 80 36 20 (with 10 lines at your disposal)

Telephone line 044 55 48 71 31 10 (24/7/365 service)

* SRAM: Suspicion of Adverse Drug Reaction, RAM: Adverse Drug Reaction, ESAVI: Event Allegedly Attributable to Vaccine or Immunization, EA: Adverse Event, EAS: Serious Adverse Event.

Pharmacovigilance Report Record

If you experience any adverse event during your participation in a clinical study where INFINITE is in charge of your driving or you experience an adverse reaction to any medication of which Infinite Clinical Research International SA de CV (INFINITE) is performing pharmacovigilance please fill out The following format with the necessary information.

Fields marked with a (*) are mandatory fields

Patient contact information

Suspicious medication