Pragmatic GCP Quality support for clinical trials and life sciences research
contact@pragma-gcp.co.uk
or use our contact form below
Proportionate and pragmatic quality support and advice
Pragma GCP Consulting is an independent consultancy, offering tailored GCP advice and support to organisations involved in clinical trials and research. Lead Consultant and Owner, Cara Williams, has worked in Quality Management/Quality Assurance in the industry since 2012, with direct experience of CROs, biotech startups, academia and other not-for-profit sponsors.
Quality Management
- QMS development, management and optimisation
- Gap analysis
- Process mapping & SOP writing
- Quality issue & CAPA management
- Assessment of potential serious breaches
- eQMS system selection & validation advice
- QMS transition after acquisition/merger
GCP
consultancy
- Vendor selection & oversight
- Risk assessment & management
- Computer System Validation advice
- Decentralised trials
- Archiving (electronic & paper)
- Clinical trial monitoring advice
- Inspection Readiness
GCP
auditing
- Audit programme development
- Study audits
- TMF
- Holistic
- Site-specific
- Process/system audits
- CRO audits (full service or individual services)
- GCLP laboratory audits
- Vendor audits
GCP
training
- Bespoke GCP training per functional area
- Focused training per GCP topic
- Training based on the organisation's policies and procedures
- Bitesize training for continuous learning
- Training matrix development
- Live/on-demand training