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    Simplified Clinical Biostatistics/Data Management

    Manufacturer: Simplified Clinical
    For over 15 years, we have developed and supported compliant, state-of-the-art clinical data systems using advanced clinical trial information management technology. Our software as a service (Saas), consulting, and support services provide the complete environment for your clinical trial.
    SKU: SCDM001
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    Biostatistics/Data Management

    Statistical Support:

    We have experienced staff who are well-versed in the planning of clinical trials as well as the analysis of data.  We can provide expertise for whatever level of support you need.

    • Review or author protocol sections with respect to statistical methodology and data management
    • Create randomization schedules
    • Author protocol-specific Statistical Analysis Plans (SAPs) including creation of table shells and listings
    • Conduct analyses per the SAP using SAS
    • Provide interpretations from data analyses to be incorporated into reports or presentations

    Data Management:

    Poised to support the management of study data by providing the following services:

    • Creation of data management plan (DMP)
    • Tracking of regulatory documents
    • Creation of integrated payment rules and creation of check requests for site payment of enrollment or form completion
    • Working with study coordinators to assure scheduling of protocol-required follow-up visits
    • Reviewing data entry and assessing necessary database changes to fields and edit checks
    • Reviewing data and adding or closing queries per the protocol and DMP

    Reporting & Data Visualization:

    Universal, real-time access to clinical data is a key to effectively managing your clinical research effort. Your ability to monitor the results of a clinical study “as they occur”, provides you an opportunity to modify the direction of the clinical study very early in its lifecycle. This saves time and money.

    We provide you with limitless access to your clinical trial data. Access levels/credentials are defined by you, and determine information availability. Access to all system reports only requires a live connection to the Internet.

    In addition to traditional reporting formats, you can intelligently present data using visualization tools to create digital dashboards, graphs/charts.