FEi has been supporting international clinical trials for NIH and Johns Hopkins University for more than ten years.  Our experience involves highly technical back-end support and coordination with frontline clinical support staff. 

Retrovirus Epidemiology Donor Study (REDS) for NHLBI

FEi provides high-end IT services at both the clinical program level and the international study level for the REDS programs.  FEi developed the International Data Center to support international retrovirus transfusion studies in the U.S., Brazil, and China. FEi is also responsible for developing and managing real-time data collection, processing and submission from five blood donor centers in China. FEi’s cost-effective solution offers several key features and important benefits, including:

FEATURES

• Open-source, web-based software that streamlines and standardizes data capture and reporting procedures from mulitple blood centers
• User-friendly toggle button to allow users to switch between Chinese and English at any time while navigating the system
• Online data entry for blood centers that do not electronically record donation information
• Capability to read blood center systems and transform varied data to standard data files

BENEFITS

• Improved the quality of data and helped streamline blood donation and transfusion services
• Provided real-time donor screening
• Generated encrypted study IDs from donor’s demographic information
• Vastly improved adverse-event reporting (i.e., 15 minutes vs. more than one week)
• Became broadly applicable for developing countries as well as for centers with specific data processing requirements
• Provided cross-site donor tracking while protecting confidentiality

Clinical and Research Laboratory (CORELAB) Management Information Systems

FEi and the Johns Hopkins University (JHU) Department of Pathology worked collaboratively to build the CORELAB system in Kampala, Uganda — a clinical and biological data processing and management system. This system tracks all information for patients, specimens, testing results, and workload in support of HIV/AIDS, TB, and other related research. 

CORELAB:

• Is one of only three accredited labs in Africa; it was designated as 1st runner up recipient of an international lab credentialing award
• Has supported more than 72 research studies from JHU, Case Western Reserve University, the National Institute of Allergies and Infectious Disease (NIAID), Centers for Disease Control and Prevention (CDC), the U.K. Medical Research Council, and the Italian National Health Institute
• Demonstrates FEI’s commitment to capacity building at the local level; this lab is fully staffed with local Ugandan clinicians, researchers, and operations management

IRB Software

FEi developed an Institutional Review Boards (IRB) Tracking Software for the Ugandan National Council for Science and Technology (UNCST).  This versatile, customizable software allows users to perform all tasks associated with tracking and managing the IRB process for human subject clinical research trials.

Originally developed to track U.S.-funded clinical trials in developing countries, the software can be customized to meet both U.S. and international requirements.

More specifically, the modules provide the following capabilities: 

• IRB Information – provides detailed profile information about each IRB, its participants and the study's subject matter.
• IRB Package Status/Submissions – tracks study submission and expiration alerts; and tracks the study status as it pertains to the IRB (e.g., pending, approved, active, expired, etc.).  
• Study Alerts – delivered via email to fully monitor the status of all clinical trials as they pertain to an IRB. 
• Clinical Trial Sponsors – information about the clinical trial sponsor is contained in this module.  It may provide a summary of the study, information about the study population, or other types of narrative most important to organizational users.