Research Service Support

Our experts provide planning, leadership and operational management for distributed collaborative research. Our 15 years of FDA Sentinel Initiative expertise can benefit your growth in federated/ distributed research arena. Services include

• Support identification of research needs​
• Research team plan, build, and maintain​
• Business expansion of clients and projects​
• Subject matter expertise in distributed & collaborative research ​

Our 15 years of FDA Sentinel Initiative and collaborative research expertise can benefit your growth in federated/ distributed research arena. 

• Mini-Sentinel
• FDA Sentinel program
• FDA Biologics Effectiveness and Safety (BEST) program
• FDA National Evaluation System for health Technology (NEST) program
• Reagan Udall Foundation for the FDA
• AMCP Biologics & Biosimilars Collective Intelligence Consortium (BBCIC)

Our 15 years of public health safety surveillance capabilities and expertise can benefit your safety monitoring for pre-Phase IV, Phase IV or prospective study planning and implementation. 

• Commercial pharmaceutical safety surveillance
• Shared protocol and federated/ distributed research networks
• Drug, biologic, and medical device uptake 
• Complication monitoring

Our experts provide planning, leadership and operational management for research data systems and analytics. Our over 35 years of data system design, data management, data transformation for the suppose of clinical analytics. Services include

• Data warehousing and sourcing
• Integration and mining of large complex healthcare databases 
• Statistical models and methodologies
• Development and implementation of complex clinical algorithms
• Market basket and group behavior methodologies

Our consultants will help you transform your data into a Common Data Model, operationalize your CDM refreshes and query execution, and support expand your potential collaborative research clients. Through, 

• Data Assessment​
• Data transformation Common Data Model (CDM) plan, specifications, trouble shooting​
• Immunization Information Systems (IIS) data transformation and support 
• Project management for IT-Data scientists / engineers/ analytics on data​
• CDM: Internal and External Quality Assurance plan and support​
• Query execution advice and support​
• Query: Internal and External Quality Assurance plan and support​

Our Principal Investigators can support  your research team during  multiple deadlines or expected / unexpected staffing gaps. Services offered include 

• Research plan development including list of research topics and conferences 
• Research plan implementation support 
• Research team growth support 
• Proposal writing / review: assessing RFP requests with company capabilities​
• Quantitative research operation problem solving​
• Manuscript writing / review: merging RFP requests with company capabilities​
• Scientific dissemination plan and support for conference / peer-review publishing​
• Project management for IT-Data scientists / engineers/ analytics on query execution

Our team has collaborated in over 12 multiple-site, multi-year validation studies utilizing administrative health insurance claims and healthcare practitioner provided charts. We'll help you use expertise and analytics to the efficient validation study.  We can assist your validation study with 

• Data Assessment​
• Vendor identification for chart requests with or without clinical chart review ​
• Project management of vendor & data exchange ​
• Claims to Medical Chart policies & procedures​
• Selection of providers from claims to support correct provider for chart request