Inspection Readiness Program

Sopheus Sciences prepares organizations for regulatory inspections by auditing and assessing clinical, laboratory, and data integrity practices in line with FDA and WHO guidelines (21 CFR Part 58). Our program provides training and documentation to ensure facilities and quality systems are fully compliant and inspection-ready.
data analysis

Clinical Trial Audits

Our experts perform study-specific GCP audits covering protocols, investigator sites, trial master files, pharmacovigilance, databases, and reporting for a wide range of clinical trials. Each audit is tailored to your compliance needs and aligned with the stage of product development.

Sopheus Sciences has conducted audits across the United States, Canada, Europe, the United Kingdom, Asia, and the Pacific Rim. We partner with sponsors and trial sites to assess, implement, and enhance quality measures that ensure compliance and maintain excellence throughout your clinical trials.