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Health Informatics and Analytics

Health Informatics (HI) encompasses the acquisition, management, delivery, and preservation of biomedical data in the contexts of health research and health care.

Solutions cover a wide range of functionality in clinical care, clinical research, and genomics and related scientific research.

RESULTS

Clinical Research
Informatics to support the full research lifecycle from preclinical through postmarketing surveillance in the journey toward precision medicine.

Clinical Care
Secure capture, integration, distributed access, and quality analysis of patient care and outcome data to improve efficacy and lowers costs.

Regulatory Compliance
Patient data management in accordance with HIPAA; validated research systems and processes compliant with FDA regulation 21 CFR Part 11. E-submissions in conformance with the Electronic Common Technical Document (eCTD) standard.

Patient Safety
Quality analysis in clinical care settings, adverse events monitoring and reporting in clinical research, pharmacovigilance in post-marketing.

ICD-10 Implementation
Quickly create team environments and enable them to collaborate with document sharing, threaded discussions, messaging, tasking, and project management.

Patient-Centric Operations
Patient-centric informatics supported by EMR, LIMS, POE, and other clinical systems streamline operations when deployed in a coordinated care framework with data and process interoperability.

CORPORATE CAPABILITIES

Biomedical Informatics
CALIBRE provides biomedical data integration, data warehousing, bioinformatics tools training and support, pharmacogenomics and related molecular analysis, text analytics and natural language processing, and high performance computing.

Clinical Informatics
HI solutions improve the efficiency of clinical research operations by automating data management for capture, secure transmission, quality control, storage, integration, and analytics.

Protocol development, case reporting, adverse event report distribution, and other documentcentric work flows can be streamlined and securely shared via document repositories and process automation.

Grants and Contracts Management
CALIBRE offers full lifecycle support for systems to manage individual grants and portfolios, and providing detailed insight and control for project officers; integration with NIH enterprise systems; lifecycle contracts management systems, performance payment systems, invoice processing, and information sharing between contracts and program officers; and vendor risk management systems.

Policy Analysis and Support
CALIBRE provides policy analysis, alternatives analysis, report preparation, and committee support for biomedical topics for government policy makers.

Pre-Clinical Informatics
CALIBRE provides systems for discovery services, compound support, animal model studies, and biospecimen data management.

Regulated Systems
CALIBRE provides FDA 21 CFR Part 11 systems and validation; audit preparation; eCTD implementation; and systems design and implementation for blood, biologics, and device regulation.

Solutions cover a wide range of functionality in clinical care, clinical research, and genomics and related scientific research.

NIH Experience
CALIBRE has provided health informatics solutions to NIH for over 20 years and currently supports 13 NIH Institutes and Centers.

We field multidisciplinary teams of domain experts in pre-clinical and clinical research operations, molecular biology, health care specialties, grants and contracts management, and 21 CFR Part 11 compliance, along with information technology professionals in data warehousing, data integration, bioinformatics tools, document management, process automation, cloud computing, and information security.

Our solutions have been recognized with numerous Institute and NIH Director awards, as well as industry awards for innovation.

FDA Experience
CALIBRE has served the FDA for over 20 years building and maintaining systems to carry out FDA’s mission to regulate blood products and other biologics.

We have played a key role in transitioning industry submissions from paper to electronic media.

Provider Experience
CALIBRE serves large hospitals and regional health care delivery systems with health informatics solutions addressing clinical research, clinical operations, contracts management, invoice processing, revenue modeling and maximization, expense analysis, and vendor risk management.

Military & Veterans Health Experience
CALIBRE serves the military and Veterans health establishments with data analytics solutions addressing clinical operations, cost, and quality.