Epidemiology Informatics and Study Management Unit Unit HEAD: Mindy Ginsberg The Epidemiology Informatics and Study Management Unit (EISMU) serves a crucial dual role in support of both epidemiological and clinical trial research management by providing overall research management expertise and informatics-based management solutions. The EISMU supports all aspects of epidemiological research with a special focus on the development of Study Management Informatics Systems (SMIS) which facilitate the diverse management, data and operational aspects of implementing complex study protocols. The SMIS incorporate automated workflow processes across shared facilities, implement QA and best practices to ensure data integrity, automate data integration from various sources, and establish real-time data monitoring in order to provide efficient research operations, improved data access and progress/regulatory reporting. The SMIS integrate with internal and external EHR and laboratory systems, and support management of multi-center clinical research projects. The EISMU has implemented the Velos Clinical Trial and Research Management System (CTRMS) to standardize and streamline all clinical trial and research process management. The CTRMS has been customized to provide QA oversight and facilitate compliance/monitoring of all clinical trial activity. Workflows, policies and procedures have been established that collaboratively engage, guide and/or provide oversight to other shared resources involved in research (e.g. CPDMU, Biorepository, Epic Research, IRB, OCT, Pharmacy, etc.). The research management process spans the lifecycle of protocol management from IRB submission to completion and the EISMU continually expands the purview of the program with the design of custom interfaces between the CTRMS, Epic and multiple IRB institutional systems to provide fully integrated regulatory and operational management of clinical trials. The EISMU also serves as the Epidemiology and Clinical Informatics Shared Resource for the Albert Einstein Cancer Center. Services Development of Comprehensive Research-based Study Management Systems Data Extraction and Comprehensive Study Data Integration Web-based Collaborative Research Portals Quality Assurance and Audit Control Systems Study Process Management, Documentation (SOPs) and Reporting Services Web-based Image Annotation Systems Integrated Clinical/Research Data Management Descriptive Analyses and Customized Programming Cancer Data Repository and Cohort Builder Tool Data Coordinating Center EISMU Staff Mindy Ginsberg Director, Epidemiology Informatics / Study Management Unit 718.430.3559 718.430.8370 Mindy.Ginsberg@einsteinmed.edu Gregory Aidinov Applications/Systems Manager Gregory.Aidinov@einsteinmed.edu Luis Bonilla Data Analyst Luis.Bonilla@einsteinmed.edu John Curran Manager of Clinical Trials Management System Velos/Data Analyst John.Curran@einsteinmed.edu Malka Felder Bioinformatics Analyst Malka.Gelbfish@einsteinmed.edu Jeffrey Geizhals Bioninformatics Analyst Jeffrey.Geizhals@einsteinmed.edu Victor Kamensky Statistical Programmer Victor.Kamensky@einsteinmed.edu Calvin Li Research Coordinator Calvin.Li@einsteinmed.edu Minerva Manickchand Project Coordinator Minerva.Manickchand@einsteinmed.edu Ronald Moore Assistant Director of Clinical Trials Management System Ronald.Moore@einsteinmed.edu Martin Packer Lead Bioinformatics Analyst Martin.Packer@einsteinmed.edu Noel Relucio Systems Administrator Noel.Relucio@einsteinmed.edu Chedva Rosenbaum Research/Data Coordinator Chedva.Rosenbaum@einsteinmed.edu Jatin Solanki Lead Applications/Systems Manager Jatin.Solanki@einsteinmed.edu Allan Spielman Lead Software Developer Allan.Spielman@einsteinmed.edu Nataliya Tappen Lead Software Developer Nataliya.Tappen@einsteinmed.edu Ronald Zappulla Lead Bioinformatics Analyst / Senior Data Architect Ronald.Zappulla@einsteinmed.edu
