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Quantitative Signal Detection
Commonwealth Quantitative Signal Detection Services from Commonwealth Informatics support drug safety reviewers with the detection of safety signals from the FDA Adverse Event Reporting System (FAERS).
Commonwealth’s CVW Professional Services Team provides exceptional leadership and support of CVW cloud environment deployments.
Public Health Surveillance
Commonwealth Informatics’ Healthcare Analytics Group provides services to support deployment, ongoing operations, and enhancement of the ESP and EpiTrax platforms
Quantitative Signal Detection
Commonwealth Quantitative Signal Detection Services from Commonwealth Informatics support drug safety reviewers with the detection of safety signals from the FDA Adverse Event Reporting System (FAERS). Commonwealth Quantitative Signal Detection Services, paired with the Commonwealth Informatics team’s experience and expertise, helps smaller safety groups proactively and effectively manage risk.
Characteristics of Quantitative Signal Detection Services include:
Proven Statistical Methods
The statistical methods and data visualization techniques provided by the Services have been developed in collaboration with safety scientists in regulatory and sponsor organizations in the USA and Europe.
Clean Data & Reliable Results
Commonwealth’s extensive experience in cleaning spontaneous report data for optimized data mining includes:
- Mapping adverse event reports to a consistent event terminology.
- Drug name harmonization, cleaning verbatim drug names, and mapping trade and generic names.
- Quality assurance of the updated data prior to release for use.
Commonwealth’s CVW Professional Services Team provides exceptional leadership and support of CVW cloud environment deployments. With resources throughout India, Europe, and the US, this group of seasoned industry experts provides broad global support and an understanding of the diverse international regulations and requirements of the life sciences arena.
From planning through to post-production support, our CVW Professional Services Team ensures your business and quality expectations are met by providing a turnkey package that includes the following:
- Project management
- Requirements gathering
- Specification development
- Application configuration
- Data Migration from systems like Oracle Empirica Signal and TIBCO Spotfire®
- Integration with systems like Oracle Argus Safety, ArisGlobal LifeSphere®, and InSife HaloPV
- Workshops and Conference Room Pilots
- Operational Qualification/Functional Testing
- Preparation of Performance Qualification/User Acceptance Testing scripts
- Production Deployment
- Hypercare (Elevated Production Support)
Our CVW Professional Services Team includes a dedicated CVW Customer Support group focused on ensuring post-delivery customer success with daily use of CVW in their pharmacovigilance endeavors.
Public Health Surveillance
Commonwealth Informatics’ Healthcare Analytics Group provides services to support deployment, ongoing operations, and enhancement of the ESP and EpiTrax platforms in installations in multiple disease surveillance and management projects.
Created by Harvard Medical School’s Department of Population Medicine, the Electronic Medical Record Support for Public Health platform – known as ESP – is an open-source data warehouse system for Electronic Health Record (EHR) data and is used as the technology platform for the CDC-funded National Association of Chronic Disease Director’s (NACDD) Multi-state EHR-based Network for Disease Surveillance (MENDS) project.
The MENDS project uses ESP’s plugable algorithms to identify and compile disease cases and case histories and to:
- Automatically report Nationally Notifiable Diseases
- Report on Influenza-Like Illness for local public health, to the US Centers for Disease Control (CDC), and to the Prevention National Influenza-Like Illness Surveillance Program
- Detect and process cases for vaccine adverse events, with automated VAERS reporting to the CDC
- Identify chronic disease conditions of interest and create aggregate-level reporting for population surveillance using the RiskScape visualization application for aggregate-level surveillance and PopMedNet for distribution and analysis of population surveillance queries
In addition to providing informatics services to support deployment, ongoing operations, and enhancement of the ESP platform, Commonwealth Informatics guides the MENDS project by supporting all of MENDS’ multi-state installations.
EpiTrax is an open-source epidemiologic and disease surveillance system managed by the Utah state Department of Health used by public health epidemiologists and other supporting individuals for disease case surveillance and management.
The EpiTrax software provides:
- Automated processing of HL7 Electronic Laboratory Reporting (ELR) and Electronic Initial Case Report (eICR) messages to create or update an existing disease case
- A web application interface for
- managing the processing of ELR and eICR messages (EMSA — Electronic messaging staging area)
- managing disease cases, including capabilities to identify and record potential infection sources and record and monitor and trace contacts
- Automated notifiable disease reporting
- Aggregate-level analysis and reporting
In addition to providing informatics services to support deployment, ongoing operations, and enhancement of the EpiTrax platform, Commonwealth Informatics supports EpiTrax installations in Texas.
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Supporting Government Agencies in Public Health, Drug safety and Healthcare Research
Commonwealth is on GSA Information Technology (IT) Schedule 70 and is a registered contractor in SAM. Commonwealth has been collaborating with the Federal Government on a variety of projects over the past five years with agencies including the Food and Drug Administration (FDA), Department of Defense (DOD), Center for Disease Control (CDC) and the National Institutes of Health (NIH). Examples of current and prior projects are described below.
US Food Drug and Administration
- Research Collaboration Agreement (RCA) – The focus of the agreement is to enhance the Commonwealth Clinical Data Analytics™ (CCDA) platform for analyzing drug safety data. To learn more, visit our News page.
- Safety Support and Consulting Services – Commonwealth was awarded a contract to provide consulting services and technical assistance to the FDA Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). To learn more, visit our News page.
National Institute of Mental Health
Transitioning Electronic Support for Public Health (ESP) from Lab to Marketplace – The goals of this NIH-funded project are to realize the full functional potential of the open source ESP platform. Specific aims include making ESP more robust and easier to use and to deploy, and developing additional algorithms for detection and reporting of notifiable diseases.
US Department of Defense
- Development of Remediation Oriented Cohort Builder – Commonwealth is developing a web-based application to support healthcare quality improvement in the Military Health System under a Phase II Small Business Innovation Research Contract from the Defense Health Program.
- Application of Cohort Builder for Pharmacovigilance and Drug Utilization Monitoring – Under a Phase III SBIR Contract, Commonwealth is extending and customizing its Cohort Builder technology to support the mission of the Army Pharmacovigilance Center (PVC). This project includes Drug Utilization monitoring and use of visual analytic capabilities to support pharmacovigilance safety studies. An example from the project is shown in this poster presented at the 2015 OHDSI Symposium: Visual Analysis of Complex Adverse Drug Reactions in Claims Data.
- Antibiotic Study Support for Armed Forces Health Surveillance Center – Commonwealth is responsible for the collection and reporting of MHS antibiotic usage data in support of the National Healthcare Safety Network.
Centers for Disease Control and Prevention
Quality-Related eMeasures from EHR Data – In this CDC funded project, Commonwealth extended the EHR Support for Public Health (ESP) open source surveillance platform to implement a chlamydia screening eMeasure based on electronic healthcare records. Commonwealth worked with an existing ESP site to evaluate the sensitivity/specificity of the newly implemented eMeasure.
Commonwealth is an approved and experienced IT provider for government organizations helping to streamline the buying process for clients. More details on our contract vehicles is described below.
GSA IT Schedule 70
Commonwealth Informatics is an approved GSA provider on IT Schedule 70. The Commonwealth GSA Contract Number is GS- 35F-349BA.
COMMBUYS for State of Massachusetts
Commonwealth Informatics is a pre-qualified vendor active in COMMBUYS for the State of Massachusetts and we currently hold a Master Agreement on the Information Security Services, Statewide Contract for Information Technology (IT) professional Services, ITS53 Project Services, Technical Specialist contract.
Commonwealth in an approved G-Cloud provider of IT services.
UK Digital Outcomes and Specialists
Commonwealth Informatics is an approved supplier in the categories of Digital outcomes and Digital specialists.