PROTOCOL AND CRF DESIGN Protocol and CRF quality is decisive for the subsequent stages. INTRIALS' staff becomes fully involved in developing relationship with our clients and in nurturing the partnership. This aspect, together with our experience and our Excellence-driven culture, creates an environment that favors the construction of the project intelligence, concentrated in the stage of Protocol and CRFs Elaboration. Procedures of INTRIALS during this phase:   • After analyzing the project of development and the available resources, INTRIALS designs the protocol, according to the principle of good clinical practice (ICH-GCP), domestic and international regulations and the internal standard procedures of the Sponsor.   • The broad database of investigators and the relationship between INTRIALS and the Brazilian top medical community, play a positive contribution for the creation of objective and accurate protocols.   • During this phase, participation of biostatisticians ensures the appropriate sample size, contributes to an efficient design of the CRFs, therefore certifying that statistical analysis of the safety and efficacy parameters lead to solid conclusions after study termination.   • CRFs are designed with accurate criteria, aiming at functionality and efficiency, in order to become practical for the user and exact for data collection.   • The Informed Consent is written in a language adequate for the patient, in compliance with the resolutions of the National Committee of Ethics in Research and the ICH-GCP international regulations, bringing agility to the approval process.

Contact us to access a presentation about the region and to learn more about how INTRIALS can assist you conduct studies in Latin America.