Health Sciences

Our disease surveillance capabilities span a wide range of disciplines including database architecture and management; data collection, cleaning and management; and analyses. We build systems that collect and flag data, deploy and monitor survey systems, and conduct surveys in the field. Using advanced survey technology to ensure high quality and efficient data collection, we design and implement systems that monitor, characterize, and compare populations of people, professionals, and institutions.

Specific offerings that Constella provides include:

• Bio-surveillance Systems
• Health Data Services
• Health Surveillance Systems and Registries

Selected Projects

• Comprehensive Support for Monitoring Military Personnel in Receipt of the Anthrax Vaccine
• Vaccine Adverse Event Reporting System-VAERS

Comprehensive Support for Monitoring Military Personnel in Receipt of the Anthrax Vaccine

Client: Centers for Disease Control and Prevention

Constella is tasked by the Centers for Disease Control and Prevention (CDC) to develop, multiple study protocols and information technology systems to analyze, collect, and evaluate medical data of military personnel who have received the anthrax vaccine.

Supporting CDC's Vaccine Analytic Unit, Constella staff collected data from 4,300 military medical records to compare vaccine data listed on medical records against similar vaccine information contained in the Department of Defense's (DoD) Defense Medical Surveillance System (DMSS) database.

The purpose of this exercise, which required a team of medical abstractors to travel to 28 different medical facilities across eight states, was to determine the accuracy level of the vaccine data in the DMSS database. Where appropriate, the data will be used in longitudinal studies around potential side effects/"outcomes" of the current anthrax vaccine used by the military.

For the overall contract, Constella will abstract medical data from military personnel records to investigate if there are possible associations between the vaccine and various adverse health conditions, such as optic neuritis (disintegration of the optic nerve) and connective tissue diseases (e.g., lupus and arthritis). The studies will examine the medical history of vaccinated servicemen/women over six years (1998 through 2004).

From the data-accuracy determinations made through the quality-assurance assessment, CDC and Constella can better determine which study data can be pulled from the DMSS database, and which data should be abstracted from hard medical records, based on the protocol of each "outcome" study.

Vaccine Adverse Event Reporting System-VAERS

Client: Centers for Disease Control with the Food and Drug Administration

The Vaccine Adverse Event Reporting System (VAERS), mandated by Congress in 1986 and initiated in 1990, collects reports of vaccine adverse events (VAEs) as required of vaccine manufacturers and health-care providers, as well as voluntary reports from individuals who have an adverse reaction to a vaccination. The VAERS program serves as a critical national public health resource for regulatory purposes of assuring post-market safety of vaccines as well as ongoing research and surveillance of the broad impacts of vaccines on the public.

Since 1999, Constella has provided a broad range of services involving information technology, data processing and management, statistical analysis, outreach and nurse follow-up. Specific services include:

• Providing a single resource for all vaccine adverse event reporting nationwide and a single repository for collecting and maintaining these data
• Processing, cleaning, and managing all vaccine adverse event data
• Performing, reporting, and supporting analyses
• Performing outreach to the public, health practitioners, and vaccine manufacturers
• Performing in-depth clinical follow-up on serious, death, and other clinically significant cases
• Maintaining an emergency preparedness plan for responding to a mass immunization campaign or emergency response effort

The VAERS program receives between 1,500 and 2,000 reports of adverse events each month. Thanks to a significant application upgrade Constella made to the Vaccine Adverse Event Reporting System (VAERS), the system now uses the same robust, clinically validated language of medical authorities around the world. With the deployment of the new application, Constella has migrated VAERS to the Medical Dictionary for Regulatory Authorities (MedDRA), which is the official medical terminology used by regulatory authorities in the U.S., European Union, and Japan. MedDRA offers a better organized and more detailed means of capturing medically important data related to vaccine-related adverse events, and will allow CDC and the Food and Drug Administration to more effectively monitor adverse events to help ensure the safety of U.S.- licensed vaccines.