ITClinical

Founded in 2007, ITClinical (https://www.itclinical.com/) is a privately owned Portuguese SME specialised in four main areas: 1) Information Technologies for the health and pharmaceutical industries (including Pharmacovigilance activities, Clinical Trial randomisation and Stock Management, and Clinical Trial eCRF/EDC); 2) Scientific consultancy (assistance through each step of clinical development and regulatory stages: pre- and post-approval); 3) Monitoring and Auditing Activities; and 4) Technical Translations (IT, medical and pharmaceutical fields).

ITClinical has an extensive experience in software development and validation in regulated environments, and has been involved with phase I-IV & Real World Evidence clinical trials carried out in Europe, North and South America, Asia and Australia, in multiple therapeutic areas. Our regulatory and monitoring team have a long history of monitoring and setting up trials in Portugal. Our CEO and founder Miguel Almeida is a biomedical engineer with almost 20 years of experience as a software architect/developer, sysadmin and scientific affairs project manager. As ITClinical’s Scientific Line Manager, he is also responsible for the coordination of scientific teams and project management for the Scientific Affairs area.

ITClinical’s added value for the consortium is of utmost importance for the EchiLiBRiST project, in particular in the management and monitoring of the clinical trials. On one hand, our skilled and well-trained clinical staff provides the highest quality monitoring work, following the protocol-specific requirements and international guidelines (ICH and GCP), to ensure the ethical conduct of the study, the accuracy and completeness of the recorded data required to maximise the scientific validity of the study. On the other hand, ITClinical brings its proprietary Pharmacovigilance and Clinical Trial Logistics and Management systems, based on over 15 years of experience in software development and validation in regulated environments. The configuration and customisation of the software will significantly impact the clinical trials and contribute to a more efficient and optimised study.