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Retrospective Studies & Chart Reviews

Transforming Real World Data into Clinical Insights

Capturing retrospective data for analysis

Criterium creates configurable electronic data collection tools for efficiently capturing retrospective data that will be submitted for subsequent analysis to answer clinical queries. We work very closely with our clients and have strong ongoing relationships with key opinion leaders & medical experts to develop robust data capture tools that rely on scripting and revision of very specific and clearly articulated research questions for analysis.

Features & Benefits of Criterium's Solutions for Retrospective Studies

Benefits for Researchers and Study Sponsors

Real World Evidence (RWE) data can better describe how a product will perform in a broader, more representative population over time.

  • Experienced in custom configuration of web-based applications to capture high quality data 

  • Generated highly configurable templated modules reflecting expected data points for RWD collection for this study 

  • Developed eCRF forms with familiar, user-friendly ePRO formats 

  • Framework follows guidance of Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) 

  • Maintained data entry in several managed successive states to ensure integrity:
    • Uncommitted draft status, allowing changes with no required explanations
    • Commitment to a “completed data entry” review condition, requiring audit input for changes
    • Final status commitment after PI review, which also can, under certain conditions, be un-/re-finalized with audit input 

  • Notifications, instructional guidance, training manuals, modules within applications, and a review/approval mechanism provide clear navigation and guidance to mitigate errors
Features of the Data Collection Process

We help transform disparate pieces of anecdotal information into organized Real-World Data (RWD) that supports RWE conclusions; this work can add critical information for better health outcomes and more inclusive populations.

  • Close collaboration with key stakeholders (client, sponsor, sites, Criterium project & data teams, programmers and statistical teams) to generate web-based tool for normalizing extraction

  • Modular, easily configurable building block design, allowing modifications as needed

  • User-friendly interfaces for all roles and permissions with easy-to-use eCRF forms

  • Interface utilizing a wide array of real-time interactivity and guidance tools to navigate multi-level decision trees

  • Accommodation of projected statistical plan requirements which can be automated to detect patterns as needed

  • Presentation of collected data in “Statistical Analysis Plan-ready” format

Why are retrospective studies important for clinical research?

“Large, prospective, interventional clinical trials require significant funding and years of development and study execution before practice-informing results are available. There are many critical clinical questions that will never be addressed or addressable through prospective, interventional clinical trials. 

Often these data interactions can reveal multifaceted relationships between certain indications, treatment factors, dosage rates, patient characteristics, and length of treatments beyond what highly controlled clinical trials may uncover.

Ultimately, chart reviews can detect patterns and relationships among events, symptoms, and other variables.”

– Dr. Wade T. Iams 
Assistant Professor of Medicine, Vanderbilt University

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