Dove Quality Solutions

DQS is an innovative independent consultancy providing discerning quality management, meaningful risk analysis and high quality audits to reduce the time, cost and impact of quality issues in clinical research.

Cathy Dove principal consultant is a trusted Quality & Risk Management industry expert with over 25 years global pharmaceutical clinical research experience including 12 years Global Head of QA & Project Quality Management with a proven track record in driving awareness and visibility of quality through ICH GCP E6 R2 compliant quality and risk management solutions.

Cathy is an RQA GCP Committee member, course tutor within clinical quality compliance and risk management, as well as an EFGCP Quality Group member.

Cathy's expertise provides the opportunity to create bespoke quality management and assurance solutions designed to manage and mitigate risk, protect patient rights, safety and data integrity, whilst delivering successful clinical research and regulatory inspection outcomes.

DQS Services:-

Quality and Risk Management Systems from strategy and concept through to implementation:

• Provision of practical and functional risk management solutions within clinical trial operating models (ICH GCP E6 R2 compliant)
• Conduct of Covid-19 impact assessments & development of risk mitigation strategies
• Development of bespoke training programs

Vendor Oversight and Pharma / CRO Collaboration

Vendor oversight strategies developed through a thorough understanding of risks associated with outsourcing clinical trials, including:

• Vendor selection, qualification and due diligence audits
• Outsourcing strategy / governance / vendor oversight plan / vendor oversight training
• Quality agreements / quality gates / performance metrics, KPIs and QTLs

 Regulatory Inspections and Sponsor Audits

Hosting and conducting inspections and Sponsor audits, including:

• Inspection readiness assessments, interview training, inspection strategy and support
• Quality management and audit strategy

Complex Audits

Extensive experience of complex audits and ‘for cause’ audits / investigations / remote audits

Availability for Work

Remote, Asia, Australasia, Europe, North America

Areas of Expertise

Auditing, Good Clinical Practice (GCP), Quality Management Systems (QMS), Quality Risk Management (QRM), Standard Operating Procedures (SOPs), Inspection Preparation, Pharmacovigilance (GPvP)

Contact Details

Kinver
Parkham Lane
Brixham
Devon
TQ5 9JR
England

Tel: +44 (0) 7516 446246

Email address: enquiries@dovequalitysolutions.com

Website: www.dovequalitysolutions.com

Linked In: Cathy Dove

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