Xcellerate Statistical Review

Xcellerate Statistical Review ensures the validity of collected clinical study data, identifies atypical clinical site data and resolves study quality issues before they have a negative effect on the trial.

Supports adherence to ICH GCP and other guidelines through audit trails and history tracking

Accesses critical information with visualizations for metrics reporting and trending

Scales to current and future data volumes via state-of-the-art architecture

Value it Brings to the Outcome of a Trial

Through proven statistical techniques, Xcellerate Statistical Review allows statisticians to evaluate data so they can recognize erroneous entries and process errors and potentially fraudulent data. Additionally, Xcellerate Statistical Review notifies monitoring and data management teams of areas of concern throughout the execution of the trial.

Overview:

The ability of statisticians to identify study data issues in a timely fashion is critical to the outcome of any trial. Erroneous data can indicate operational issues which can be addressed early to help prioritize patient safety, improve data quality, mitigate risks, increase operational efficiency and drive more informed decisions.

Xcellerate Statistical Review allows statisticians and non-statisticians to evaluate efficacy and safety data by looking for atypical data patterns. By using statistical techniques to identify non-random anomalies and assess outliers, fraud and quality issues, the project team can target areas requiring extra attention.

Benefits of the Xcellerate Statistical Review Tool:

  • Agnostic: integrates into existing trial management source systems (e.g. EDC)
  • Compliant:支持adherence to ICH GCP and other guidelines through audit trails and history tracking
  • Easy-to-use: increases visibility into areas of concern through user-definable interfaces
  • Effective: accesses critical information with visualizations for metrics reporting and trending
  • Future-proof: scales to current and future data volumes via state-of-the-art architecture

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