WHY CHOOSE QARA

Benefits of working with QARA

Cost Effective

We conduct thorough reviews and assessments to provide expert advice and support, enabling you to execute your projects robustly, compliantly, and efficiently.

Risk Proportionate

With over 15 years of experience in assessing and mitigating risks, we design risk-adapted approaches. Risk-proportionality is inherent in all we do.

Dependable

We understand the critical importance of delivering on time and within budget. We pride ourselves on our unwavering dependability and live by the motto, "say what you do, and do what you say."

Flexible

We recognize that priorities can change, which is why we maintain an agile, solutions-driven attitude, readily adapting to evolving situations. We work closely with all stakeholders to ensure clear lines of communication, fully understanding your individual needs and requirements.

Our Background

Problem-Solving

Overhauled CRO QA department of a CRO, conducted a comprehensive gap analysis, and implemented a remediation plan, resulting in KPI improvement from 40% to over 95% compliance within five months.

Project Delivery

Successfully managed large, multi-million-pound projects, ensuring timely and within-budget completion. Designed, validated, and implemented electronic Quality Management Systems (QMS).

Change Management

Successfully merged two clinical trials units, restructured and upskilled the QA team, and built a new Regulatory department, including staff, systems, and processes.

Clinical Research Operationalization

Held various positions in project management, start-up & feasibility, regulatory affairs, clinical operations, pharmacovigilance, medical writing, data management, and quality assurance.

National Professional Committees

Active member of RQA’s Good Research Practice Special Interest Group, with six years of membership on the UKCRC’s QA Operational Group.

National Research Initiatives

Authored MHRA-endorsed internal audit prioritization guidance, tool, and training. Collaborated with MHRA and leading clinical methodologists on multiple UKCRC projects, including IT vendor selection & oversight, electronic Trial Master File, and the implementation of EU Clinical Trials Regulation & CTIS.

Who We Are

Katie Neville is the founder and Head Consultant of QARA Consultancy. As a distinguished member of both TOPRA and RQA, she serves on the RQA’s Good Research Practice Special Interest Group.

With over 15 years of experience in clinical research, Katie has honed her expertise in both public and for-profit sectors, holding various operational roles before specializing in quality assurance and regulatory affairs. Her first-hand experience in operations is invaluable for quality professionals, enabling them to better assess and adapt compliance to suit their organization’s requirements.

Katie began her career at the University of Leeds' Clinical Trials Unit (CTU), which was instrumental in pioneering risk-based approaches. The university's collaboration with the MHRA to develop its Risk-Adapted Approaches guidance allowed Katie to deeply embed risk-proportionality into her approach to quality and compliance. During her tenure in the public sector, Katie established close working relationships with national regulators such as the MHRA and HRA, and was nominated to the QA subgroup of the UKCRC’s CTU Registered Network.

QARA Consulting is uniquely positioned to leverage Katie’s extensive experience in risk-proportionality and regulatory collaboration to benefit our clients, enhancing their efficiency and compliance within their organizations.

QARA Consultancy LTD. Registered in England and Wales. Registered Address: 86 Melling Road, Liverpool, L9 0LQ.

Company Registration No: 16188234. VAT Registration No: 485 3538 58.