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The Nathan S. Kline Institute for Psychiatric Research

Information Sciences

Computer Center
Innovative Clinical Research Solutions
Information Sciences

Innovative Clinical Research Solutions (ICRS)

 
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Baerbel Allingham, Dipl. Inf. Med.
Database Administrator
Caroline Tobey
Clinical Trials System, Project Manager; FDA Compliance Specialist
Audrey Bauzó-Rosario, MA, CCDM, CCRP
Senior Data Manager; Quality Assurance Monitor
Neikeisha Marcelle, M.P.A.
Senior Data Manager

Innovative Clinical Research Solutions (ICRS) offers complete data management services tailored to specific study requirements and expectations throughout the course of a clinical research study, including protocol review, case report form (CRF) development, ongoing data management, safety monitoring, regulatory reporting, and data repository sharing. Our expertise extends from initial protocol review to data lock and statistical analysis. 

Our Mission

To support clinical research using information science and computer technologies in order to advance a clinical project to a successful conclusion.

  • Support for single and multi-site clinical research studies
  • Rapid CRF development and study deployment
  • Integration of data from many sources
  • Rapid and effective problem resolution
Overview

ICRS personnel have experience in data management, clinical study monitoring, quality assurance, clinical research informatics, case report form design, site management, teaching, and recruitment strategies.  Staff backgrounds include decades of clinical research experience plus psychiatric nursing, public health administration, social work, medicine, law and medical writing. 

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We support trials conducted by pharmaceutical companies, academic institutions, and investigator initiated studies.  From multi-site (40+ sites) trials to single site small trials, from Phase I through Phase IV trials, ICRS meets the demands of the protocol as well as the funding agencies.  We are one of the first DMCs (data management centers) to work with the NIH Data Repositories to fully satisfy all requirements of federally-funded data sharing mandates. The ICRS Data Management Center employs a comprehensive data management methodology that encompasses all aspects of clinical research from conceptualization to completion.

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Services We Provide

ICRS offers these major services:

  • EDC Development
  • Data Management
  • Clinical Monitoring
  • Quality Assurance
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  • EDC Development: ICRS is a leader in the development of state-of-the-art electronic data capture (EDC) systems for use in clinical research, from small investigator-initiated studies to large, multisite FDA clinical trials. Our Acquire EDC system includes mobile, self-reported, and audio-assisted features, while meeting all FDA, HIPAA, and FISMA regulations.
  • Data Management: ICRS offers complete data management services tailored to specific study requirements and expectations. Our expertise extends from initial protocol review to data lock and statistical analysis. We provide extensive study development services and offer a wide range of data management services throughout the course of a clinical trial, including protocol review, Case Report Form development, ongoing data management, safety monitoring, and regulatory reporting.
  • Clinical Site Monitoring: Our experienced team of Clinical Research Associates (CRAs) works in close collaboration with clinical trial management to ensure the success and efficiency of a trial. ICRS CRAs regularly monitor Investigator Initiated and Industry Sponsored clinical trials around the globe, from study start-up to closeout. With a focus on early identification and rapid resolution of issues and incorporation of Risk-Based Monitoring, ICRS works to ensure the highest quality review of data and effective interaction with study sites.
  • Quality Assurance: We are committed to quality. Our multidisciplinary team of professionals create customized QA plans to assure data quality. After conducting a data audit, the QA team presents a detailed report noting discrepancies, errors, outliers and bias in the data, and provides suggestions for developing and implementing an effective Corrective and Preventative Action (CAPA). ICRS strives for continuous improvement throughout the course of a clinical trial and the QA Team focuses on ensuring valid, accurate and complete data.
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Some Current Projects
  • Recovery After an Initial Schizophrenic Episode: Early Treatment Episode - RAISE
  • New Experimental Medicine Studies: Fast-Fail Trials in Autism Spectrum Disorders (FAST-AS)  (HHSN2712012000051)
  • New Experimental Medicine Studies: Fast-Fail Trials in Psychotic Spectrum Disorders (FAST-PS)  (HHSN2712012000071)
  • Improving Care and reducing Cost (ICRC) – Center for Medicare and Medicaid services
  • Implementation of an Evidence-Based PTSD Treatment in Public Sector Settings