The highly motivated and qualified personnel of the medical area of BRCR Global, provides a rigorous support guided by the Federal Policy for the Protection of Human Beings (the Common Rule) and the principles described in the Belmont Report (respect for people, charity and justice) and the Nuremberg Code. The rights and welfare of all persons involved in the investigation shall be vigorously protected. The individual elements of our Monitors constitute a system that is easily adaptable to the changes. The improvement of quality can only be achieved, through the implementation of positive changes, ensuring the implementation of the corrective actions and the communication of the implementation of the quality system for the research staff.

BRCR Global offers Clinical Monitoring services through our team of Clinical Research Associates (CRAs) with a wide experience in ICH-GCP guidelines and local regulations. All personnel receive continuous training related to the basic principles of clinical research, the protection of the subjects, as well as the key procedures of the project.

Monitoring activities include pre-site visits at the sites, site initiation, intermediate clinical monitoring, and closure visits. BRCR Global adopts a proactive approach to problem identification and resolution, as well as supervision of site administration, employing extensive experience in electronic data collection, case report file systems and standard operating procedures.

BRCR Global also considers important tasks in the Clinical Monitoring such as:

• Verification of the suitability of the site staff during the study

• Verification of attachment to the protocol

• Informed consent process

• Ensuring that site personnel is always properly informed about the study

• Recruitment and enrollment status of patients

• Report and management of negative events

• Review of the investigator's file / availability of essential documents

• Accurate and complete study records