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.
Based in Cambridgeshire in the UK, the team offers technical expertise with particular strengths including:
- Robust knowledge and understanding of the regulatory environment governing clinical trials globally, in particular in the EU and North America.
- Set-up and governance of Quality Management Systems; preparation and execution of GCP audit plans.
- Direct experience of regulatory approval, clinical trial management and oversight of early phase clinical trials with biological and advanced therapies (gene therapies, stem cell therapies).
Our professional consultancy team is comprised as follows:
Sarah Fryer, MSc MRQA MICR MRSB MIOD (Director and Head of QA)
Sarah Fryer, founder of QRCC, has over 30 years experience in the pharmaceutical industry, primarily in the management of clinical research programmes, GCP QA auditing and Quality Systems Management.
A graduate from Surrey University with an MSc in Toxicology, Sarah moved from pre-clinical research into clinical drug development working in both small company and CRO environments.
As Managing Director for the UK office of an international CRO, she facilitated the attainment of ISO certification.
In 2003, she was co-founder of the expert regulatory and clinical research consultancy, Gregory Fryer Associates, leading the company to win the prestigious Genesis Award "Professional Service Provider of the Year 2010" in London in December 2010.
Sarah is a Member of RQA, ICR, the Society of Biology and the IOD.
Sarah Nicholson, PhD MTOPRA (Director and Head of Regulatory)
Sarah graduated from the University of Manchester with a PhD in Neuroscience and has worked within the industry for over 16 years. Sarah is experienced in all aspects of regulatory affairs including Scientific Advice, ODDs and CTAs and has worked in a pharmaceutical company and CROs. Sarah is a member of TOPRA.
Alex Gage, BSc (Head of Clinical Operations)
Alex graduated from the University of Nottingham with a BSc (Hons) and has over 19 yearsâ€™ 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 Contract Research Organisation. Alex has experience of a wide range of therapeutic areas within clinical research across different phases of development, plus Alex is a member of the ICR.
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 industry for over 16 years and is experienced in formulation and project management. Katie provides technical support to the Quality, Regulatory and Clinical teams. Katie is a member of the RPS.
Lucielle Mansfield, PhD (Senior Clinical Project Manager)
Luci graduated from the Nottingham Trent University with a PhD in Microbiology and has over 13 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 the ICR and HSRAA.
Vicky Lock, BSc (Hons) (Clinical Project Manager)
Vicky graduated from the Open University with a BSc (Hons) in Molecular Science and has over 14 years of experience in the 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.
Chloe Bryan, BSc (Hons) (Clinical Research Associate)
Chloe Bryan joins the team as a 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 contract research organisations. Chloeâ€™s experience includes the monitoring and management of several clinical trials (PI â€“ PIII) in different therapeutic areas, including liaison with Ethics committees, Competent Authorities and CROâ€™s. Chloe a is a member of the ICR.
Jenny Velic, MBiochem (Regulatory Consultant - Clinical)
Jenny graduated from the University of Oxford with a Masters in Biochemistry (Hons) and has over 11 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 and EMWA.
Christina Tam, BSc PhD (Regulatory Executive)
Christina graduated from King's College, London with a BSc (Hons) in Pharmacology with Toxicology and a PhD in Pharmacology. Christina has over 3 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.
Jo is a clinical research professional with over 25 yearsâ€™ 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 the ICR.
Sam has worked in the pharmaceutical industry for almost 15 years. She is an experienced QA professional and member of the RQA providing GCP advice and guidance to operational business groups. Sam is GDMP Lead Auditor Qualified and a GCP Auditor with experience of Investigator Site Audits, Clinical Trials and Systems and Process Audits. Sam has facilitated successful agency inspections (FDA and MHRA) including inspection readiness activities. Specific areas of expertise include orphan drugs, oncology and neuroscience.