Our differential
PROCESS MANAGEMENT
We have a database of approximately 4,000 potential volunteers, sourced from our clinic. The evaluation and approval of new studies by the team, based on protocol analysis, takes on average 10 days. Our average screening failure rate is 12%, and the dropout rate is 14%. The average time for budget review and approval of a study is 10 days.
Our mission is to conduct clinical studies with responsibility, technical expertise, and complete data integrity. We bring extensive experience in all stages of clinical trials, from protocol development to the execution of their various phases. Moreover, we frequently serve as the coordinating center in multicenter studies.
Additionally, drawing on our accumulated experience, we have been operating as a Contract Research Organization (CRO) since 2006, responding to the needs of clinical trial sponsors.
In August 2004, we had the privilege of being audited by the U.S. Food & Drug Administration (FDA), the international authority responsible for regulating food and drugs in the United States. The audit focused on our Research Unit, which was conducting a multicenter study involving 54 sites across 12 countries.
After a week-long evaluation, the FDA concluded that we were fully compliant with all applicable legal and regulatory requirements. Moreover, we achieved the highest enrollment rate and the lowest discontinuation rate among participants, reaffirming the quality of our work. This recognition provided greater confidence in our operations and strengthened trust in the excellence of our performance.
QUALIFICATION
PERSONNEL QUALIFICATION
The Clinical Research Unit (CRU) believes that any task can only be performed with excellence when entrusted to qualified professionals. Guided by this institutional perspective and backed by over 40 years of experience, the CRU invests in the continuous training of its team and associated collaborators. Upon joining the CRU, new collaborators undergo a comprehensive clinical research training process and engage in activities that promote discussion, such as our Continuing Education Program. Additionally, the unit welcomes interns, offering an excellent opportunity for them to learn and gain expertise in clinical research, contributing to their professional development.
The Clinical Research Unit (CRU), in its commitment to continuous improvement and team training, maintains a Continuing Education Program that is also open to external professionals interested in the field of clinical research. This program aims to foster engagement and interaction among researchers, CRU members, invited guests, and other participants, covering a wide range of essential topics in clinical research.
PROCESS QUALIFICATION
The working methodology of the UPC team, upon receiving a new research protocol proposal, is to conduct a thorough assessment. The goal is to effectively contribute to the execution of the proposed investigation, both in collaboration with the CRO (when applicable) and with the sponsors. This analysis is also performed with the aim of transparently verifying UPC’s actual feasibility in conducting the proposed study, ensuring that resources, personnel, and infrastructure are adequate to meet the protocol’s requirements.
Internal Monitoring is a permanent practice at UPC and consists of the systematic review of ongoing studies. This activity is carried out by a duly qualified member designated for this role. The practice aims to ensure the quality of processes conducted within the Unit. We are a pioneering center in developing this activity and have received significant recognition for the quality of our work, which has been continuously improved through this practice.
UPC operates on the principle of partnering with sponsors in the conduct of clinical trials. To ensure this partnership is effective, every team member assigned to an approved study undergoes specific training. This training is designed to ensure proper qualification in executing study procedures, while maintaining quality, regulatory compliance, and excellence in research conduct.
When a study is approved and accepted for development, it is standard practice to prepare a specific SOP for the clinical trial. This internal document is designed to support researchers and the coordination team in carrying out the procedures at each stage of the investigation, ensuring process uniformity and strict adherence to the protocol.
ORGANIZATIONAL COMPLIANCE
The Clinical Research Unit adopts and develops Standard Operating Procedures (SOPs) in its services with the aim of ensuring uniformity, quality, and compliance in the activities carried out. These procedures are fully aligned with international standards and ANVISA’s Normative Instruction No. 4, and are consistent with Good Clinical Practices (GCP) and applicable national and international clinical research regulations. The SOPs are periodically reviewed.
The Clinical Research Unit (CRU) Quality Control Manual aims to describe the quality management system adopted in accordance with current legislation. The manual is periodically reviewed and updated, ensuring the quality of services provided. It offers clients, sponsors, auditors/inspectors, and partners an overview of the organization, strengthening trust among all parties involved.