Meet PHARMExcel’s Head of Quality Assurance – what do they do, and what experience does it take to get there?
We sat down with Allyson McLean to find out more about her quality experience before joining PHARMExcel, what her responsibilities as Head of Quality Assurance are, and her thoughts on the industry.
Allyson started her healthcare career as a general nurse and then studied part time to pursue a Bachelor’s in Nursing with Health Studies. She then studied for a Masters in Quality Management in Scientific Research & Development, again part-time
Her career in clinical research began as a site coordinator and research nurse and she then undertook training as a Clinical Research Associate (CRA). Allyson moved into Quality Assurance (QA) within Phase I clinical trials, working across Pharma Research and Development (R&D) in various quality and compliance roles, including establishing and maintaining Quality Management Systems, regulatory inspections and audits, risk assessment quality improvement, as well as clinical operations and pharmacovigilance. She has previously led the design and implementation of inspection awareness/readiness activities both within the UK and globally within various companies.
In February 2021, Allyson joined PHARMExcel as Head of Quality Assurance, and has developed and adapted the role as the company’s needs have grown and changed. Her responsibilities include implementation and management of the electronic quality management system (eQMS), ensuring procedures are standardised across the systems, and overseeing the training for Dot Compliance, an eQMS which enables documentation management in one system. Allyson is also responsible for internal and external audits/inspections, Corrective and Preventive Actions (CAPA), and Quality Management Reviews and oversight of quality across the company.
Launch of electronic quality management system solution (eQMS)
2023 has been a big year for technological development at PHARMExcel. The quality management system was launched on Dot Compliance – an innovative, cloud-based QMS solution that will enhance PHARMExcel’s business quality and clinical management operations.
Following this launch, Allyson said, “With the rise of regulatory demands and challenges in the market, knowing that we have built a robust eQMS solution into our business and clinical processes is peace of mind for me as Head of Quality Assurance. We nurture a culture here that expands beyond standard quality and compliance which means we can offer our clients and partners a better experience including cost efficiencies, transparency, and robust risk management.”
This new technology integration marks a key milestone in the company’s digital transformation strategy and an important move towards expanding its quality and regulatory capabilities. Allyson is proud of this development, noting that it streamlines PHARMExcel’s operations and standardises procedures across the business and within the industry.
Development of digital clinical trial management system (CTMS)
The introduction of its clinical trial management system (CTMS) has allowed PHARMExcel to stay responsive and at the forefront of the fast paced and competitive life sciences landscape. Allyson notes that many of the small-medium sized CROs are still reliant on a paper-based or Sharepoint-based system.
Achieving ISO 9001:2015 global standard
Allyson was thrilled to have implemented ISO 9001 at PHARMExcel. This certification is a demonstration of PHARMExcel’s commitment to quality assurance, showing its focus on delivering a high level of customer service quality regardless of client size or scope of work. The certificate is evidence the company is continually improving its processes and managing business risk to meet the expectations of its sponsors and stakeholders.
With all this achieved in the last year, the focus now is on maintaining the momentum and staying at the forefront of digital systems management.
Thinking over her 30 years in the clinical research industry, Allyson notes that historically the sector hasn’t seen many regulation changes, with long gaps between new guidance being released. However, Allyson welcomes the changes that have been introduced since the pandemic, and more so in the last 12 months, with the Government proposing streamlining the procedures supporting the approval and conduct of clinical trials, removing duplicative requirements, and enabling flexibility in a risk-based and proportionate manner. Allyson expects to see more changes in 2024.
Allyson predicts that the industry will become more patient oriented – working to involve patients more in clinical research and listening to their needs to improve the patient journey and clinical outcomes. Patients will be invited to share their opinions more frequently and will be better informed when consenting to studies.
Another change Allyson noted is the standardisation of EU regulations and the development of new UK regulations following Brexit. With the UK working hard to streamline the approvals process to accelerate clinical research, Allyson acknowledges that the National Institute for Health and Care Research (NIHR) has been diligently working on this. There is an agreed need to make the UK more appealing for clinical research, as discussed in Lord O’Shaughnessy’s review of clinical trials in the UK in May 2023 and the Government’s response in November 2023. For Allyson, the prospect of updated and streamlined regulations is an exciting development.
One of the questions we asked Allyson was what she likes the most about working at PHARMExcel, and here’s what she had to say.
Allyson appreciates that she shares a core value with PHARMExcel – quality. It’s something she is passionate about and has dedicated her career to. It’s a value shared by PHARMExcel’s CEO and founder, Yvanne Enever, who also has a background in quality, and Allyson believes that this has helped build a strong culture of quality at PHARMExcel, joking that it has made her role easier.
Allyson highlighted the important role her colleagues play in implementing quality assurance across the company and gave a shout out to Carol Osuji, PHARMExcel’s Quality Assurance Manager.
We wanted to know a bit more about Allyson outside of her role at PHARMExcel. Here is what else we asked!
If you could have dinner with any famous person, alive or dead, who would it be?
I’ve always wanted to meet Nelson Mandela. He’s top of my list; I thought what he did was amazing.
If you had as much money as your phone number, what would be the first thing you bought?
The first thing I’d do is share it with my family. Then, with what’s left over I’d book tickets on a world cruise. I’d love to visit South America as it’s the only continent I’ve not been to!
We also asked some quick-fire questions:
Tea or coffee? Tea 🍵 ☕️
Morning or night? Morning ☀️
Marmite – yes or no? No, never! 🤢
Text or phone call? It depends…text for handiness 📱
Messy or clean desk? Clean… most of the time! 🗃️
We then asked our final question.
What is the best advice you’ve received – either in your career or in life?
To be happy in whatever you do.
If you’re not happy then you’re not going to be successful!
Thank you Allyson for giving us an insight into your role and allowing us to get to know you better.
You can learn more about the people behind PHARMExcel here!
PHARMExcel is an award-winning, full-service Contract Research Organisation (CRO) providing a flexible and innovative approach to clinical trial delivery. The company is recognised for its in-depth knowledge and experience of the clinical research environment, particularly in the UK, and has a network of regulatory and industry associates, allowing it to provide a global reach.
Katie Howe, Head of Marketing
T: +44 (0)20 3642 6654