Omnia Quae

Omnia Quae Ltd. is an independent quality and compliance consultancy specialising in services for Clinical Research. Omnia Quae are able to assist in the evaluation and audit of sites, processes, computer systems and service providers that have the ability to impact on all aspects of Clinical Research.

Omnia Quae also have experience in providing GCP remediation priorities and plans to assist clients throughout Clinical Development as well as assisting clients in preparing for Regulatory Inspections.

Projects undertaken include, but are not limited to: 

• Investigator site audits
• Clinical Study Report audits
• Clinical Research process audits
• Vendor oversight evaluation and remediation
• SOP evaluation and remediation
• Third party contract evaluation and remediation
• Sponsor roles and responsibilities evaluation and matrices
• CRO/Third Party audits
• Archival facility audits
• Trial Master File (including eTMF) audits
• Computerised system audits
• Regulatory inspection readiness
• ICH GCP E6(R2) gap analysis
• Information Technology and Information Security evaluation and audits
• Computer System Validation audits
• CAPA management evaluation and remediation
• Risk based audit program evaluation and remediation

Availability for Work

Worldwide

Areas of Expertise

Clinical Research, GCP, GcLP, CRO/Third Party, CAPA, Computer Systems and Regulatory Inspections 

Contact Details

Caroline Gibson
Datchworth, Hertfordshire, UK

Email: cgibson@omniaquae.com

Website: www.omniaquae.com

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