PHARMExcel is one of the few UK-based Contract Research Organisations (CROs) of its kind to be certified to ISO 9001:2015 underscoring its commitment to quality, customer focus, and excellence in clinical research. This article explores what ISO 9001:2015 means and why it matters selecting an ISO-9001 compliant CRO.
ISO 9001:2015 is a globally recognised standard for Quality Management Systems (QMS). Developed by the International Organisation for Standardisation (ISO), it provides a comprehensive framework for ensuring consistent, high-quality products and services across industries.
To achieve and maintain certification, PHARMExcel undergoes a rigorous annual audit process by the British Standards Institute (BSI), the global leader in standards, proving its commitment to efficiency, quality, and continuous improvement across all its business processes and clinical research services.
In the challenging field of investigational medicinal product (IMP) and medical device clinical trials adhering to an international quality standard is important to the service we are able to provide to our clients. Clinical trials are complex and demand strict adherence to regulatory requirements and quality standards, particulary under the EU Medical Device Regulation (MDR) and UK MDR. Our certification demonstrates that PHARMExcel consistently follows an international quality standard across the business (clinical and non-clinical) and aligns with industry-leading quality benchmarks, providing its clients with the confidence needed in a clinical research partner.
Selecting the right CRO is pivotal in clinical research. The clients who choose to partner with us gain distinct advantages including:
"The support from PHARMExcel has been extremely high quality. This includes all aspects in trial development, management and monitoring, that was also evidenced by a recent sponsor audit. We look forward to working with PHARMExcel going forwards."
Tom Fletcher, CST-6 Candidate Chief Investigator, Director Global Health Trials Unit Liverpool School of Tropical Medicine
At PHARMExcel, we chose to pursue ISO 9001:2015 certification to stand out as a CRO that doesn’t just talk about quality, but make itself accountable for delivering excellence in clinical research. Whilst many UK CROs aren’t certified to ISO 9001, we opted to follow the ISO standards framework to ‘enhance’ our organisation and add value to our clients.
Our ISO 9001 certification reflects key strengths, including:
At PHARMExcel, we believe quality is the foundation of impactful clinical research. With ISO 9001:2015 certification, we demonstrate our commitment to careful planning, efficient execution and thorough analysis while always maintaining excellent study integrity.
“For me, achieving ISO 9001:2015 is a reflection of PHARMExcel’s core commitment to doing things right—from the way we manage trials to how we engage with our clients. It’s not just about meeting a standard; it’s about building a culture of quality that our clients can genuinely rely on. ISO 9001 keeps us accountable, pushing us to refine our processes and keep client needs at the forefront. Every time we renew this certification, it reinforces our dedication to running clinical research with integrity and precision”, said Shaun Hastings, Director of Clinical Quality Assurance, PHARMExcel
Contact us today to learn more about our quality-driven research services.
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