Real-time Expert Data Review

PES’s proprietary methods minimize risk and augment accrual, compliance, and retention.  Central to these methods is the real-time endpoint data quality review (EdQ™) that we provide. To ensure that your study yields a consistent and complete dataset, PES will:

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    Designs worksheets and tools for the clinical raters that enable uniform, disciplined, and complete data collection for the trial’s specific clinical endpoints

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    Perform real-time review of all patient subject assessments, validating completeness and consistency

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    Provide immediate feedback to investigators and sites; alert gaps in accuracy, compliance, and any unexplained anomalies; provide feedback to sponsor and CRO for correction

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    Model blinded endpoint data at any time, based on proprietary historical databases

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    Provide CRO with metrics to optimize study subject retention; dropout monitoring and analysis

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    Collaborates with medical monitors as a subject matter expert

Centralized Scoring

When protocol endpoints require that a ‘grade’ or ‘score’ be provided (based on a clinical observation), site-based clinical raters / assessors can introduce an enormous amount of variability into a trial’s dataset. As an extension of PES’s integrated services, we centralize the scoring of ‘observed symptoms’ and take this burden off the hands of the sites.

Within a regimented process, PES will:

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    Provide site assessors with a customized protocol-specific worksheet for gathering patient and symptom observations in a uniformed way

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    Provide site assessors with a customized protocol-specific worksheet for gathering patient and symptom observations in a uniformed way

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    Provide a score or grade via an on-team indication-expert review that leverages our multi-layered proprietary method

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    Perform a final validation of the patient assessment / score, and submit the data to the CRO for recording

How we work

PES reviews and assesses all incoming trial data as it’s reported by the trial sites.  Expert indication-specific clinicians pore over each submission, looking for completeness and consistency.  Incomplete or anomalous submissions are flagged immediately and sent back to the trial sites for further clarity or correction.

Why we do this

Site assessors frequently have different interpretations of how to map the severity of symptoms to a scoring scale. This can introduce an incredible amount of variability into the trial’s dataset.  By crafting protocol-specific worksheets for the clinical raters to use when gathering patient-subject data, PES simplifies the data submission process and uses its expert clinicians to evaluate the data in real-time.

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