Our Services
Specialists in Quality Management and Risk Analysis, ensuring you are always Inspection Ready
Dove Quality Solutions specialises in pragmatic quality management and impactful risk analysis services. We enhance your Quality Management Systems to minimize the time, cost, and impact of quality issues in clinical research. Our expertise includes high-quality audits, thorough inspection preparation and management, and customized training to ensure your teams grasp the importance of first-time quality and remain consistently "inspection ready".
Quality and Risk Management
Hands on knowledge and experience in the development of Quality & Risk Management Systems from strategy and concept through to implementation:
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Provision of practical and functional risk management solutions within clinical trial operating models that are fully compliant with ICH GCP E6 R2
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Conduct of Covid-19 impact assessments & development of risk mitigation strategies
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Provision of risk management process training
Vendor Oversight
Vendor oversight strategies developed through a thorough understanding of risks associated with outsourcing clinical trials, including:
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Vendor selection, qualification and due diligence audits
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Outsourcing strategy / governance / vendor oversight plan / vendor oversight training
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Quality agreements / quality gates / performance metrics, KPIs and QTLs
Quality Consulting
Providing GCP knowledge and experience to organisations beginning their journey into clinical research programs.
Complex Audits
Extensive experience of complex audits and ‘for cause’ audits / investigations / remote audits:
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Investigator Site Audits
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Internal System Audits
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Vendor Audits
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GAP Assessments
Regulatory Inspections
Hosting and conducting inspections and Sponsor audits, including:
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Inspection readiness assessments and inspection strategy and support
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Quality management and audit strategy
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Up-to-date regulatory intelligence through RQA GCP Committee membership and a broad network of industry contacts
Bespoke Training
Training packages targeted to the needs and experience of your organisation;
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GCP Training
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Quality and Risk Management Training
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Managing Trial Risks, training for project managers
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Inspection readiness and interview training