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:
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:
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.
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.