Clinical research quality services
Helping pharmaceutical clients achieve regulatory compliance
Keen Quality Consulting is a specialised provider of clinical research quality services, tailored to the specific needs of pharmaceutical clients in achieving regulatory compliance.
Director and consultant Mary Keenaghan has over 25 years experience in Good Clinical Practice and clinical research quality. Contact her on LinkedIn or by email at the links below.
Keen Quality services
As an established independent consultancy, Keen Quality Consulting works with small and large organisations to support their QMS development needs and inspection readiness activities.
- QMS/procedure development and co-ordination
- Quality issue management and CAPA
- QMS harmonsiation
- TMF reviews and gap analysis
- Vendor management support
- Inspection readiness and mock inspections
- General GCP, compliance and QA support
- Supporting European Medicines Agency & MHRA requirements
Testimonials
"We have enjoyed the collaboration with Mary across different quality related projects and have been always amazed by her in depth knowledge of clinical compliance subjects and her experienced approach in dealing with tasks and challenges that are beyond the usual day-to-day quality activities."
"Her expertise is merged with an exceptional capability of liaising with the client specific needs and internal resources and this made successful all projects we have worked on together."
About Keen Quality Consulting
Keen Quality Consulting Director and consultant Mary Keenaghan has over 25 years experience in GCP, QA and QM. Mary is a high performing, committed, innovative and ethically driven clinical research quality professional, with experience in both clinical research and site management organisations. She established Keen Quality Consulting in Glasgow, Scotland in August 2021.
- Audits, mock inspections, gap analysis, managed global quality teams, defined strategy for QA and QM including audit and compliance programs,
- Compliance input and supported improvements to operational processes, QMS (Quality Management System) development and developed and delivered staff training.
- Supported clients with QMS development activities and harmonisation, procedure development, training, vendor selection.
- Designed and managed quality issue reporting and resolution processes, including assessment of risk (regulatory / business / legal / reputational), root cause and CAPA tracking and trending.
- Designed and managed resourcing processes for global quality teams.
- Collaborated with project teams and clients on quality matters, quality oversight and governance.
- Developed strategies and tools to support business development opportunities.
- Summarised and presented quality and audit trends for upper operational management. Developed key performance and key quality indicators (KPIs and KQIs).
- Key player in several acquisitions/mergers, in process and procedural harmonisation and in development of quality management systems.
- Preparation and facilitation of regulatory inspections (routine and directed) and client audits.
- RQA (Research Quality Association) Member.
- Former lay member of NHS Research Ethics Committee 2009 – 2015.
