Regulatory Submission Review

Our experienced pharmacovigilance team help to assure the quality and integrity of data submitted to the FDA or other regulatory authorities by reviewing your submission content. At Guires, we perform a critical review of the following:-

• Data Conformance: We ensure that data are formatted according to the latest data standards (CDISC Compliance and CDISC mapping expertise) and comply with the FDA data Standards Catalogue.
  • SDTM Compliant Datasets (define.xml, cSDRG, aCRF).
  • ADaM Compliant Datasets (define.xml, ADRG).
  • eCTD compliance.
• Data Quality oversight services by Guires ensures the quality of the data associated with the submission. Our quality assurance (identification of outliers, and inconsistencies across studies) is based on the FDA endorsed Software CluePoints, and SAS JMP as appropriate.
• Statistical Review of Submission data: Our proficient biostatisticians ensure to identify any anomalies and missing data and in addition, the following will be reviewed-
  • Cross check the protocol versus confirmed population.
  • Examine the consistency in the efficacy analysis across timepoints, regions, population and sites.
  • The dosing decision is justified based on the evidence.
  • Reviewing existing regulatory guidance and relevant literature to examine endpoints appropriateness.
  • Understanding confounding factors.
  • Review adverse events distributions.
  • Dose related toxicity effects are checked.