Research Informatics

FHI provides global data management support for multi- and single-site research studies. FHI systems support quality research rather than drive research methodology. Our field-proven regional data management system allows us to collect data globally and enter it locally over the Internet into our 21 CFR Part 11 compliant database management system. In this way, researchers can gather, enter, and manage data locally in areas with poor connectivity.

We provide a full range of support for research studies, including

• data management plan writing
• creation of database management systems
• entry and cleaning of data
• creation of data sets
• coding of data with the Medical Dictionary for Regulatory Activities (MedDRA™)
• data management site assessments
• on-site training on data management principles and good clinical practices
• assessments for 21 CFR Part 11 compliance
• a one-week, hands-on data management training course
• development of clinical research data management centers in resource-poor settings