The know-how of BRCR Global, with a professional approach supported by a qualified staff, will guide the sponsors in a proactive way, through the filing process for the qualification in order to obtain in the most expeditious manner the approval of the protocols, the researchers and approvals of import certificates with the local Ministries of Health and Ethics Committees of the country where the study is been conducted.

We are able to provide consulting services and presenting of regulations, with the support of recognized regional research centers in North America, Latin America, Central America and the Caribbean Antilles.

Activities related to human clinical tests must follow the standards specified by government and international agencies, and other harmonization entities. These regulations and standards are designed to protect the safety and privacy of the participants, as well as to guide the decision-making process in an ethical manner based on the results of the studies, respecting at all times the scientific integrity of such tests.

The private practice, interpretation or implementation of these regulations is based on the characterization of the intended population and the established use for pharmaceutical devices or medical products.

The main reference documents are provided by the both main regulatory entities:

The FDA and the ICH. Government agencies and similar international regulators, such as EMEA (European Medicines Agency) and PMDA (Japanese Agency for Pharmaceutical and Medical Products) which oversee the activities within their respective jurisdictions, but are strongly influenced by the standards granted by the FDA and the ICH.

Compliance with the good clinical practice principles (GCP), including the correct protection of the human subject (HPS), is universally recognized as a critical requirement for carrying out research on human beings. Many countries have undertaken PCB principles as laws and / or regulations. The FDA´s regulations for conducting clinical trials, which have been in place since the 1970s, address both PCB and HSP. These FDA´s regulations and guidance documents are accessible from this link: 

ScienceResearch

The PCB is an international standard of ethical and scientific quality to design, carry out, record and report trials which involve the participation of human beings.

Compliance with this standard provides a public guarantee that the rights, safety and well-being of the subjects of the trial will be protected, in accordance with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data they are truthful.