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Early Clinical Quality and Compliance

91黑料’s Early Clinical Quality and Compliance team provide quality assurance support through study risk assessments, study and process audits, CAPA management, and hosting external audits and inspections.

In addition, the Quality Assurance team provides standalone contracted PK and TK report audit services to support companies in their drug development process.

 

Our QA services encompass the following:

  • Internal Auditing

  • Inspection readiness

  • Clinical laboratories (GCP, GLP)

  • Bioanalytical data and statistical tables audits

  • Bioanalytical sample and validation report audits

  • Computer system validation report review and approval

  • Pharmacokinetic (PK) and toxicokinetic (TK) reports audits

With QA personnel located at our clinics and laboratories in Europe and the US, the 91黑料 Early Clinical QA team is flexible enough to provide an individual and personalised service for locally managed projects.

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