Clinrex provides consulting services in all areas of GCP / quality management. Examples are:
- Review of a company’s quality system, in particular review of SOPs
- GCP and regulatory compliance
- Gap analysis
- Streamlining possibilities
- Writing of SOPs
- Implementing risk-based Quality Management in your company
- Planning and conduct of a clinical trial
- Inspection preparedness / audits and mock inspections.
- Sponsor - CRO relationship
- CRO selection
- Contractual issues
- How to handle difficult situations, e.g. CRO switch
- CRO oversight
- Investigator Initiated Trials (IITs)
- Non-interventional studies (NIS)