Phartrials monitors Clinical Research and Relative Bioavailability/Bioequivalence studies at an on-site study site, in compliance with Good Clinical Practice (ICH - GCP) regulations, with reporting to the Sponsor and Study Sites, including preventive and corrective actions.
We are enabled to perform in accordance with Good Clinical Practice (ICH – GCP) standards and in compliance with our own Quality System (SOPs) and guidelines, ensuring that the clinical study is conducted, recorded and reported in full compliance with the clinical protocol.
Clinical study monitoring aims to represent the sponsor at all stages of conducting a clinical study in the processes performed by the Study Site, from pre-study to post-study.
In addition to a highly qualified technical team to perform the monitoring service, Phartrials has as its differential a customized computerized system, used by the team via tablet, which allows real-time monitoring of the activities monitored during the stages of a clinical study. This is a differentiator that ensures that monitoring services are healthy and safe, in addition to optimizing monitoring processes.
Phartrials started with this service in 2020 and has performed more than 100 monitoring in Research Centers, with total satisfaction of Customers.

Technical Documentation in CTD format (according to Guide 24/2019), common format for the preparation of an application for registration and post-registration of well-structured drug to be submitted to ANVISA:
- Administrative Information (module 1) – Specific to ANVISA;
- CTD index (2.1);
- CTD Introduction (2.2.);
- Non-clinical Modules (2.4, 2.6 and 4):
Bibliographic Survey for the composition of the Technical Documentation
Non-clinical Overview
Tabulated and Written Nonclinical Summaries (Pharmacology, Pharmacokinetics, and Toxicology)
Nonclinical Study Reports
- Clinical Modules (2.5, 2.7 and 5):
Systematic Review of the Literature of Clinical Studies
Clinical Overview
Clinical Summaries (Biopharmaceutic Studies, Analytical Methods, Clinical Pharmacology, Efficacy and Safety)
Clinical Trial Reports

Drug Clinical Development Dossier (DCDD), compiled from documents to be submitted to ANVISA for the purpose of evaluating the stages inherent to the development of an experimental drug in order to obtain information to support the registration or post-registration changes of said product.

Investigator’s Brochure, a document that contains the compilation of the nonclinical and clinical data of an investigational medicinal product that are relevant to the study in humans, with the purpose of providing investigators and others involved in the conduct of the clinical trial with information regarding the dose, dosing regimen, methods of administration and safety monitoring procedures.

Pharmaceutical Bioequivalence study protocols, document that describes the objectives, design, methodology, statistical considerations, and organization of the trial. It also provides the context and rationale for the clinical trial.

Relative bioavailability/bioequivalence studies, evaluation of clinical, bioanalytical, and statistical data and information (reporting) to identify regulatory adequacy needs.

Technical-Scientific Reports:
- Efficacy and safety – specific drugs;
- Linear pharmacokinetics for biowaiver.

Making package inserts, with information on prescribing, preparation, administration, warning and other guidelines for safe use and effective treatment.

Ensure, through auditing the Research Center, compliance with processes and Good Clinical Practices for carrying out Pharmaceutical Bioequivalence studies to qualify it as a supplier.

Ensure compliance of the Pharmaceutical Equivalence Center's processes and Good Laboratory Practices in Pharmaceutical Equivalence tests for Drugs to qualify it as a supplier.

A process for determining the effectiveness and efficiency of the quality system implemented in the company in accordance with the specified quality objectives, the QMS audit is an indispensable tool. The audit assesses the state of adequacy and compliance of the system in relation to the standards, policies, strategic objectives, and procedures defined and applied by the Client.