QUALITY, REGULATORY, CLINICAL
Who We Are
Based in Cambridgeshire in the UK, the team offers technical expertise with particular strengths including:
Robust knowledge & understanding of the regulatory environment governing clinical trials globally, in particular in the EU & North America.
Set-up & governance of Quality Management Systems; preparation & execution of GCP audit plans.
Direct experience of regulatory approval, clinical trial management & oversight of Early Phase Clinical Trials with biological & stem cell therapies.
Who We Are
QRC Consultants Ltd is a team of experienced QA, regulatory and clinical research professionals, dedicated to providing high quality, practical, responsive and cost effective services to support biotechnology and pharmaceutical companies primarily with early stage clinical development.
QRCC strives to add value to your product as we assist you in reaching key milestones.
Our professional consultancy team is comprised as follows:
Sarah Nicholson, PhD
Director and Head of Regulatory & Quality
Sarah graduated from the University of Manchester with a PhD in Neuroscience and has worked within the industry for over 20 years. Sarah is experienced in all aspects of regulatory affairs including Scientific Advice, Orphan Drug Designations, Clinical Trial Authorisations and Marketing Authorisation Applications. Sarah has held positions in several CROs and a small pharmaceutical company. Sarah has experience of a wide range of product types across a number of therapeutic areas from oncology to neurodegenerative disorders and is a member of TOPRA.
Alex Gage, BSc (Hons)
Director & Head of Clinical Operations
Alex graduated from the University of Nottingham with a BSc (Hons) and has over 24 years’ experience within the pharmaceutical industry, working primarily within clinical operations managing clinical trials and project teams both within the UK and globally. Alex has held numerous positions at a large pharmaceutical company, worked as an independent consultant and for a UK-based CRO. Alex has experience of a wide range of therapeutic areas within clinical research across different phases of development and is a member of ICR.
Chloe Rybinski, BSc (Hons) - Senior Clinical Research Associate
Chloe graduated from the University of Worcester with a BSc (Hons) in Biology. She has experience as a CRA within the pharmaceutical industry and has worked at an investigator site, a pharmaceutical company and CROs. Chloe’s experience includes the monitoring and management of several clinical trials (PI – PIII) in different therapeutic areas, including liaison with Ethics committees, Competent Authorities and CRO’s. Chloe is a member of ICR.
Vicky Lock, BSc (Hons) - Senior Clinical Project Manager
Vicky graduated from the Open University with a BSc (Hons) in Molecular Science and has over 15 years of experience in the pharmaceutical industry, with experience in clinical biomarker assay development and clinical project management. Vicky has worked at a biotechnology company and CRO and is a member of ICR and BACR.
Elena Perez del Notario, MSc - Principal QA Consultant & QA Manager
Elena graduated from Universidad Complutense Madrid with a Pharmacy degree plus a Master’s in Drug Research and Development at the Universidad de Navarra, and Specialist in Medicine for the Pharma Industry at the Universidad Complutense.
Elena has more than 29 years’ experience in the pharmaceutical industry and has held a number of different posts in Research and Development both in the UK and in Spain. Areas of specific expertise include the establishment, oversight and management of GCP Quality Management Systems to support clinical and non-clinical development activities. This includes SOP preparation, review and maintenance, GCP/GLP audits, CAPAs, risk assessment and GCP/regulatory compliance. Therapeutic areas of particular experience include: oncology, HIV, and transplants.
Elena is now focused on GCP QA consultancy and audit services and has oversight of the QRCC internal QMS. Elena is a member of the RQA
Joy Eldridge, PhD - Principal QA Consultant
Lucielle Mansfield, PhD - Senior Clinical Project Manager
Luci graduated from the Nottingham Trent University with a PhD in Microbiology and has over 17 years of clinical experience. Luci has previously managed clinical trials within the UK and EU across a range of therapeutic areas and various phases of development. Luci has experience of working in both a pharmaceutical company and a clinical trial unit. She is a member of ICR and HSRAA.
Christina Tam, BSc PhD - Senior Regulatory Consultant
Christina graduated from King’s College, London with a BSc (Hons) in Pharmacology with Toxicology and a PhD in Pharmacology. Christina has over 11 years experience in the pharmaceutical industry and 10 years in academic research. Christina provides support to regulatory consultancy services over a range of products from small molecules to advanced therapies. Christina is a member of TOPRA.
Katie Tam, MSc - Quality Consultant & IT Manager
Katie graduated from the University of Sunderland with a BSc (Hons) in Chemistry and Pharmaceutical Sciences and Kings College London with an MSc in Pharmaceutical Technology. Katie has worked in the pharmaceutical industry for over 20 years and is experienced in the management of GCP Quality Management Systems to support clinical development activities. Katie provides technical support to the Quality, Regulatory and Clinical teams. Katie is a member of RQA and the RPS.
Jenny Velic, MSc - Principal Regulatory Consultant
Jenny graduated from the University of Oxford with a Masters in Biochemistry (Hons) and has over 19 years experience within the pharmaceutical industry. Jenny has a variety of experience within Clinical, Pharmacovigilance and Regulatory functions, primarily focusing on Medical Writing and Project Management. Jenny is a member of ICR, EMWA and TOPRA.
Jo Woodward - Senior Clinical Research Consultant
Jo is a clinical research professional with over 25 years’ experience in the pharmaceutical industry. Key areas of expertise and experience include project management and monitoring of Phase I/II clinical studies; with wide experience of early phase trial designs in a range of therapeutic areas which include pain, respiratory, opioid substitution therapy and addiction. Jo is a member of ICR.
Our Focus is on Quality
QRC Consultants are experts supporting regulatory compliance for biotechnology and pharmaceutical companies in clinical drug development.