Section of Informatics

Welcome to ATRI Informatics

Led by Director Gustavo Jimenez-Maggiora, the Informatics Section is comprised of a group of experienced informatics and bioinformatics researchers, computer scientists, data management, and information technology professionals that have been working closely with the ACTC and ATRI Principal Investigators and their study teams for over 20 years.

ABOUT

Vision

To change the way data, talent, and technology are integrated to facilitate discoveries in biomedical research.

Mission

We bring innovation and excellence in clinical research informatics, clinical data management, and information technology to improve the efficiency and quality of every stage of the biomedical data lifecycle.

Values

  • Respect
  • Acceptance
  • Fairness
  • Accountability

Origins

The Informatics Section has developed innovative biomedical informatics applications and systems that have supported the successful conduct of hundreds of single- and multi-site clinical studies in AD and other neurodegenerative diseases. Specifically, the team has developed several open-source software packages, including the ADCS EDC clinical data management system (Jimenez-Maggiora et al., 2012), the ATRI EDC clinical data management system (Jimenez-Maggiora et al., 2022), the TRC-PAD trial recruitment informatics platform (Jimenez-Maggiora et al., 2020), and an artificial intelligence (AI) enabled adverse event classification system (Ravindranath et al., 2017). These systems allow study teams to effectively manage a broad set of study activities in a rapid, transparent, and collaborative manner.

The Informatics Section also provides clinical data management (CDM) leadership and oversight for ACTC and ATRI trials. CDM processes are managed per standard operating procedures (SOPs), institutional policies, regulatory guidelines (FDA, ICH, GCP), and applicable laws. CDM policies and SOPs are aligned with the Society for Clinical Data Management’s (SCDM) Good Clinical Data Management Practices (GCDMP) guideline. GCDMP defines minimum standards and best practices for excellence in the “design of paper and electronic case report forms (eCRFs), clinical trials database design and programming, data standards, system implementation, data acquisition, data integration,[sic] into the clinical trials database, data review, validation, coding, and database finalization” (GCDMP, Executive Summary, 2022, p. vii). Following these SOPs, the CDM team works closely with each study team to provide study databases that are accurate, secure, reliable, and analysis-ready in an efficient, effective, and timely manner.