Expertise.

GCP Consulting (Clinical Trial).

Optimise your clinical quality system with our Life Science Consultants.

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Sure.

Work with correct source data verification (SDV) and verification (SDR).

Conform.

Be up to date with BRA framework and RBM.

Ready.

Be ready for Regulation 536/2014.

GCP Consulting needed?

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How we can support you with GCP Consulting.

  • Compliance with Regulation (EU) No 536/2014
  • GCP risk management implementation/assessment
  • GCP-QA Implementation/ Evaluation
  • GCP Site Qualification and Training
  • Data Integrity, GCP (REG 534/2014) & GCLP (EMA/INS/GCP/532137/2010) Audits
  • SDV (Source Data Verification) and SDR (Source Data Review) Compliance and Data Integrity Assessment
  • Inspection readiness (GCP and GCLP)
  • State-of-the-Art Concepts for BRAT (Benefit-Risk Action Team) and RBM (Risk-Based Monitoring) Implementation/ Assessments

GCP Consulting needed?

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