Health Sciences

We develop tools and processes that streamline access to critical health data and allow it to be interpreted. By creating customized, searchable web-based information repositories and tools for extracting and storing data and content from various information resources, Constella enables you to focus on what the data says, not how to access it.

Constella can provide survey design, sampling and recruitment, pretesting of data-gathering tools to determine respondent interpretation, and tracing and locating of respondents. Our processes enable us to collect self-reported data electronically either through web or telephone or through assisted collection by a call center or field staff. In addition to being able to gather self-reported data, we’ve developed processes that allow us to abstract medical data from medical treatment facilities worldwide.

Once the data is in our client’s customized system, we provide efficient and effective storage, retrieval, analysis, and presentation of data and information, all the while ensuring the collected and stored data has accuracy, integrity, validity, and consistency.

Constella also develops data acquisition systems for laboratories, clinical studies, and field data collection. These include automated capture from instruments, error-detecting data entry systems utilizing web portals, and electronic notebook systems tailored to specific field operations. We back up these capture systems with Good-Clinical-Practices-compliant and Good-Laboratory-Practices-compliant data management systems and data analyses tailored to the specific questions you need your data to answer. Our professional biostatisticians, biomathematicians, and bioinformaticists are expert at collaborating with researchers to frame appropriate questions, designing studies to collect data that will answer the questions, and using the latest techniques to analyze and interpret the data. In the past three years our quantitative scientists have collaborated with clients to publish 50 articles in peer-reviewed journals.

Specific offerings that Constella provides include:

• Health Data Services
• Record Linkage Methods Development and Practice
• Bioinformatics
• Genetic and Genomic Data Analysis
• Statistical Analysis and Mathematical Modeling for Toxicology
• Chart Abstraction and Coding System
• Enterprise Knowledge Repositories
• Research Laboratory Information Management Systems
• State/Regional Health Data Partnership
• State-based Vital Statistics Reporting

Selected Projects

• BioSense
• Vaccine Analytic Unit – Anthrax Vaccine Study
• Mortality Medical Data System (MMDS)
• Vaccine Adverse Event Reporting System

BioSense

Client: Centers for Disease Control and Prevention

BioSense is CDC’s early health-event detection and situational awareness surveillance system for monitoring any potential disease outbreaks in the United States. For BioSense to be effective, it needs data in real-time from health-data sources from across the country. For this project, Constella develops significant relationships and leads business, legal, and technical discussions to convince organizations to contribute patient health data to CDC.

In 2005, CDC had an ambitious goal – set forth by the White House - of connecting sites in 10 cities by the end of the year. As of Oct. 31, 2005, had Constella secured a commitment to participate from 23 organizations representing 109 hospitals…far exceeding the initial goal and CDC’s expectations.

Vaccine Analytic Unit – Anthrax Vaccine Study

Client: Centers for Disease Control and Prevention

In 1999, Congress directed CDC to conduct research on the safety and efficacy of the anthrax vaccine. Leading the initiative is the Vaccine Analytic Unit (VAU) a research collaboration between the CDC, the Department of Defense (DoD), and the FDA.

Constella serves as the CDC’s contractor to support the Vaccine Analytic Unit (VAU) to help investigate possible relationships between the Anthrax Vaccine Absorbed (AVA) and adverse health events in military personnel. VAU examines a number of priority research topic areas to look for these associations, including lupus erythematosus, optic neuritis, arthritis, erythema multiforme, and multiple immunizations.

Constella is assisting the VAU in developing multiple study protocols to analyze, collect, and evaluate medical data of military personnel who have received the anthrax vaccine.

Mortality Medical Data System (MMDS)

Any time someone in the United States dies, a cause-of-death classification is assigned to their record. NCHS, the federal organization responsible for managing this information, needed a way to automate the entry, classification, and retrieval of cause-of-death information on death certificates.  In order to do this, Constella developed the MMDS. When state vital statistics offices enter a cause of death description into a death certificate, the MMDS automatically matches the description terms against an extensive dictionary of medical terms to determine the official cause-of-death classification code and assigns it to the record. 

Vaccine Adverse Event Reporting System

Client: Centers for Disease Control and Prevention

The Vaccine Adverse Event Reporting System (VAERS), mandated by Congress in 1986, collects mandatory reports of vaccine adverse events (VAEs) — i.e., when people have a negative reaction to a vaccine — as well as voluntary VAE reports from individuals. When Constella won the contract, the VAERS database had approximately 140,000 reports and was growing at a rate of approximately 1,000 new reports per month. The data management system developed by the previous contractor was inadequate to support the future direction and needs of the VAERS program. Constella, in collaboration with CDC and FDA staff, architected and developed a completely new web-based system for capturing, processing, cleaning, tracking, and disseminating VAE-related information.  

The VAERS project has been appraised at Capability Maturity Model Integration (CMMI^SM) Level II based on the Standard CMMI Appraisal Method for Process Improvement (SCAMPI^SM).