Raising the bar in clinical research outsourcing| PHARMExcel CRO

At the heart of PHARMExcel’s success is Yvanne Enever, a passionate and visionary leader who has steered the company through 14 years of remarkable growth and evolution. With an unwavering commitment to building a truly value-led organisation grounded in the principles of Teamwork, Honesty, Integrity, Passion and Quality, our CEO has fostered a distinctive culture that revolves around its most valuable asset – its people.

Yvanne shares her thoughts on the key events and sector initiatives that emerged in the last 12 months, which she believes will shape PHARMExcel and the CRO industry in 2024.

Raising the bar in clinical research outsourcing

“We’re gearing up to another exhilarating year for CROs and the UK clinical trial sector. The ever-evolving nature of our field demands that we stay ahead of the curve, embracing innovation and anticipating challenges.

Before we dive into 2024, I want to share a key lesson I took away from 2023 – the paramount importance of personal and organisational resilience. Change is inevitable, and the last 12 months reinforced the importance of not only adjusting to change but actively embracing it to remain relevant and outcome driven.

Advancements in clinical research

In 2023 we witnessed important advancements in the biotechnology space, paving the way for continued progression in gene and cell therapy technologies, the integration of digital tools, wearables, and health apps for patient monitoring and data collection, and continued efforts for developments of antiviral drugs for the treatment of COVID-19.

We welcomed the O’Shaughnessy review, published in May 2023, which addressed many challenging aspects of UK clinical trials, and in response, the UK Government has committed to making it easier for innovative healthcare products to get to patients by cutting the regulatory burden of approving clinical trials.

As a leading Contract Research Organisation (CRO), our ability to adapt, pivot, and find innovative solutions for our clients, in the wake of regulatory and policy changes, remains the pillar of PHARMExcel’s mission.

Turning vision into achievements

As we navigate the complexities of the evolving clinical trial landscape, our dedication to excellence, integrity, and continuous improvement remains unwavering. I see these changes not as challenges but as opportunities to contribute meaningfully to advancements in healthcare.

Whilst 2023 was not without its challenges, I am thrilled at the role PHARMExcel played in raising excellence for clinical trials across the UK academic sector.

Our accomplishments in this demanding period were driven by the hard work of the entire PHARMExcel team, its clients, and partners.

1. Risk Based Monitoring (RBM)

In 2023, PHARMExcel continued to stay ahead of evolving industry standards and regulatory expectations by focusing on identifying and managing its portfolio risks, contributing to more efficient and cost-effective initiatives for its sponsors, whilst ensuring the quality and integrity of the clinical trial data.

PHARMExcel has routinely deployed a mixed methodology of centralised, remote and on-site monitoring, based on comprehensive risk assessments undertaken for each clinical trial. New processes and ways of working have been introduced within its Quality Management System (QMS) throughout 2023 to support these initiatives.

We have focused resources on sites and processes with higher risk levels, such as our early phase platform studies, and utilised remote monitoring strategies implementing bespoke tools, electronic data capture (EDC) systems and other eClinical technologies, reducing the need for on-site visits.

Working in conjunction with our sponsors, we now develop quality management plans for each trial outlining Quality Tolerance Limits (QTLs), triggering on-site visits or corrective actions when data deviates beyond acceptable limits.

2. Patient diversity and inclusivity

PHARMExcel took meaningful steps to support its sponsors, ensuring patient diversity and inclusion remain at the forefront in its clinical trials.

We have worked alongside patient and public involvement (PPI) representatives throughout some of our trial design processes, seeking input on protocol development, recruitment strategies, and participant engagement initiatives.

We utilised our large network of research-active investigators during the study feasibility stage, ensuring diversity among the investigators and research staff involved in the trial, and thus enhancing cultural competence and rapport for our participants.

Collaborating closely with our sponsors to review and adjust inclusion and exclusion criteria during study set up, has ensured that the real-world diversity of the patient population is reflected, and recruitment success can be optimised.

3. Published research

I was extremely proud to see our academic paper on Persistence of immune responses after heterologous and homologous third COVID-19 vaccine dose schedules in the UK: eight-month analyses of the COV-BOOST trial published in the Journal of Infection. Working on this study was a real privilege and I am grateful for the amazing team and participants who made the study possible. Read more

4. Technology integration for enhanced efficiency

Embracing cutting-edge technologies, PHARMExcel made significant strides in enhancing trial efficiency and data management. The introduction of a new Clinical Trial Management System (CTMS) and Electronic Trial Management File (eTMF) has allowed us to stay responsive and at the forefront of the fast paced and competitive life sciences landscape. With many small-medium sized CROs still reliant on a paper-based system or Sharepoint this development puts PHARMExcel ahead of the curve.

5. International recognition for quality excellence

We were thrilled to gain ISO 9001:2015 certification, demonstrating the outstanding quality of our customer service. We’ve worked hard to continually improve our processes and manage business risk to meet the expectations of our sponsors and stakeholders. Read more

6. Partnerships and collaborations

In 2023 we forged several new strategic partnerships and collaborations that enabled us to expand our diverse pool of expertise. Our new collaborations resulted in the ability to tackle large and more complex studies that before may have been beyond our scope. We were also delighted to continue our partnerships with the broader scientific community, such as UK-CLIF, a dynamic new network of clinicians, patients, carers/relatives, and researchers coming together over the shared interest to improve research and clinical outcomes for people with chronic liver failure.

Our success is intrinsically tied to the satisfaction of our clients. Listening to their needs, understanding their challenges, and consistently delivering value have been our guiding principles. As we reflect on our achievements, it’s crucial to acknowledge the role our clients play in shaping our journey. Building and nurturing long-term relationships has not only contributed to our growth but has also fuelled our achievement of excellence.

Our journey doesn’t end here: 2023 was a foundation for the continued pursuit of excellence in clinical research. PHARMExcel remains steadfast in its mission to contribute to the advancement of healthcare, and we eagerly anticipate what the future holds.

Thank you to the PHARMExcel team for your continued commitment and hard work as we embark on a new year of challenges and opportunities.”

About PHARMExcel

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.

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