Pragmatic GCP Quality Support
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 start-ups, academia and other not-for-profit sponsors.
Meet Our Founder
Guiding Clinical Research with Experience, Integrity & Purpose
Cara Williams, PhD
Lead Consultant & Owner
Cara Williams is the Lead Consultant & Owner of Pragma GCP Consulting.
She has worked in Quality within the clinical research industry since 2012 and has held positions in a large academic trials unit, a leading global CRO, an innovative biotech start-up, and a clinical trials centre within a well-respected UK charity. Cara's key strengths of relationship building and retaining a holistic viewpoint result from her exposure to many different therapeutic areas and operational functions.
Quality Support and Advice
Proportionate and Pragmatic
- Quality Management
We offer end-to-end Quality Management support designed to strengthen and streamline your organisation’s clinical research processes. We help you develop, refine and transition Quality Management Systems, ensuring they are efficient, compliant and suited to your operational needs. Our work covers everything from identifying gaps and mapping processes to crafting SOPs, managing quality issues and guiding CAPA strategies. With expertise in modern eQMS platforms and post-merger transitions, we ensure you have a solid, future-ready QMS that supports reliable, compliant trial delivery.
- GCP Consultancy
Our GCP consultancy service provides clear, practical guidance for organisations navigating the complexities of clinical research. We support you in selecting and overseeing vendors, managing risk throughout the study lifecycle, and ensuring your systems and technologies meet regulatory expectations. Whether you are exploring decentralised trial approaches, shaping your archiving strategy, or preparing for regulatory inspection, we offer independent, experienced advice that keeps your research compliant, efficient and audit-ready.
- GCP Auditing
We deliver professional GCP auditing tailored to your study, your systems and your organisation. We build and deliver audit programmes, covering processes and systems, study-specific audits, and GCP service providers. We have a depth of experience, enabling us to provide audits that are fair, thorough and action-orientated. We cover CROs, GCLP laboratories, and other GCP-relevant vendors. Each audit is designed to highlight strengths, pinpoint risk areas and support continuous improvement across your clinical research activities.
- GCP Training
We provide flexible, bespoke GCP training that helps teams understand their responsibilities and work with confidence. Training is shaped entirely around your organisation—its procedures, its risk profile and its functional areas. Whether you need focused topic-specific sessions, broad role-based training or short continuous-learning modules, we create learning experiences that are engaging, relevant and aligned with your internal policies. Delivered live or on demand, our training ensures your staff stay informed, capable and consistently compliant.