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GCP Compliance

Sophie Mepham has extensive experience in leading Competent Authority inspection and audits by the TGA, MHRA and FDA, as well as conducting sponsor-driven independent audits. The following services can be provided to sites who have remedial or corrective actions that require management to ensure a successful outcome for Sponsor or Competent Authority inspections and audits and to ensure GCP compliance:

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  • Review of GCP report and recommendations for remedial action for all identified deficiencies/issues

  • Develop Corrective and Preventive Actions (CAPAs) and support sites to implement

  • Provision of GCP Standard Operating Procedures (SOPs) and Policies and Procedures

  • Review existing GCP SOPs and Policies and update/amend

  • Training of site staff in all applicable SOPs and policies

  • Training of site staff in GCP

  • Development of all templates and documents required for site GCP compliance​

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In addition, sites can request a full pre-audit or pre-inspection review to ensure site readiness.

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Please contact us if you have any questions about audit or inspection preparation or would like support following an audit or inspection

Trial Unit Operational Management

We can also provide extensive support in ensuring trials sites and units are set up for success by providing consulting and guidance in the following general trial management areas:

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  • Staff education and training

  • Quality Management Systems

  • Clinical Trial Org structures and position descriptions

  • Trial data and systems

  • Research Governance and Oversight

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Please contact us if you require any assistance with the set up and/or operational management of new or existing trial sites or trial units.

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