Clinical Research

Pkinetix provides CRO selection and oversight for clinical studies across Latin America.

We support the following types of clinical studies:

  • Phase I-IV Clinical Studies.
  • BA-BE Studies: Fast and Fed.
  • PK / PD studies.
  • BE Studies for Drug Combinations.
  • PD Studies for Hormones and Biomarkers.
  • Mathematical Modelling of PK Data.

Pkinetix supports global sponsors who wish to carry out phase I-IV clinical trials and BA-BE / PK-PD studies in Latin America. Our collaboration agreements with CROs and KOLs across the region and our staff of expert clinical research professionals allow us to be the sponsor’s eyes and ears on the ground in the region.

From before your trial begins, Pkinetix offers feasibility analysis to understand the recruitment reality for your study and helps your firm to select the best CRO in the region for the type of trial to be conducted. Among other things we evaluate the CRO’s clinical, bioanalytical and statistical infrastructure and technical capabilities as well as their SOP’s to ensure strict compliance with ICH and GCP.

Our seasoned professionals perform country by country analysis of regulatory requirements for the execution of your clinical study evaluating all current relevant regulations at regional notified bodies such as ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), COFEPRIS (Mexico) etc. We evaluate the CRO’s budget proposal for the study and negotiate directly with them and with other service providers in order to provide the sponsor with cost effective execution of its clinical study.

We then work shoulder to shoulder with selected CRO’s providing technical and regulatory advice for the proposed study, customizing it to your needs depending on country of origin.

PKINETIX carefully supervises all phases of execution of your study, assists with protocol design, drafting of study documentation and submissions to Ethics Committees, IRBs and local regulatory authorities.

Finally, we supervise the drafting of final study reports to be presented before the sponsor’s local regulatory authority in accordance with country-specific requirements for the submission of documentation and deliver final study reports and all relevant study documentation to the sponsor.