Catalysing Excellence in Industry Trials

At Frontier Science Scotland (FSS), our experience working with a wide range of industry sponsors and pharmaceutical companies spans decades.

While our attitude to serving clients in this sector does not differ from our academic projects, it’s our understanding of both worlds that delivers value for clients.

“We bridge the gap,” says Eric Riley, Head of Development. “Supported by FSS’s diverse portfolio across multiple industry and academic projects, we offer a strong and unique perspective because we understand how both systems work.”

From global pharmaceutical leaders to start-ups, FSS has supported global clinical trials to succeed in bringing life-improving therapeutics to market. Such intricate knowledge of industry sponsors and pharmaceutical companies has fed into FSS’s versatile working model, which – combined with our team’s expertise – makes the organisation well-suited for serving clients in this sector.

Going the extra mile

Flexibility is a critical strength of FSS, according to Robin McConnell, Data Management Team Lead. “When working with our partners, we consider all of their needs and requirements when designing and providing solutions. Launching a trial can be a stressful process for researchers. That’s why we assist by adopting an agile and accommodating approach rather than a one-size-fits-all.”

This was evidenced during the COVID-19 pandemic, which – as was the case for many other clinical research projects across the world – demanded a reassessment of operations in multiple FSS trials, including OlympiA.

“The [FSS] team coordinated data cleaning and statistical analysis while working remotely,” says Robin. “Despite challenges, such as the immediate halting of monitoring and patient visits, all activities were completed on time with a positive result for the study.”

FSS has also agreed to take on additional responsibilities outside the original contract specification for other projects, such as the ALEXANDRA trial.

“We were able to flex and provide additional support that wasn’t in the original scope of the contract,” says Eric Riley, Head of Development. “That strengthened our relationships and proved fruitful for collaboration.”

In another project for a key industry breast cancer trial, we assumed further statistical and data management tasks including statistical monitoring, quality tolerance limits and the management of non-eCRF data.

“The client came to us because they needed a solution. We listened, figured out their needs and said, “Okay, we can do that,”’ says Robin.

Our willingness to take on more responsibilities results in huge internal and external benefits. We invest in upskilling our workforce to meet these new requirements and, in turn, this new expertise transfers to our customers.

“ I think that’s what makes us stand out,” says Eric. “It’s our ability to come up with solutions to problems that aren’t necessarily traditional and to carve out the time and resources to do that.”

Additionally, we also look for opportunities to use this new knowledge to spread the word about clinical trials and educate the public.

Robust relationships at the heart of projects in industry

Understanding a client’s project vision and aims is central to providing actionable, effective solutions. That’s why we prioritise regular contact from a project’s beginning – building collaborations that ultimately deliver high-quality results.

It’s not just a case of passing information backwards and forwards,” says Robin. “We want to have collaborative conversations via video meetings – and also face to face, where possible – that involve experts in the field from both sides [the sponsor and FSS].”

For the OlympiA project, for example, FSS prioritised regular in-person meetings with key project partners, such as Breast International Group (BIG). This has translated into high-yielding partnerships with sponsor and pharmaceutical companies that go well beyond project lifecycles.

Eric credits FSS’s ability to retain exceptional staff for achieving this.

“Rarely is there any turnover in our teams when dealing with customers over the long term,” he says. “That makes a huge difference in terms of moving the work along and knowing where things are, whereas other CROs have high staff turnover in my experience.”

Robin agrees, stipulating that clients benefit from what he calls our organisation’s ‘corporate memory’ of a trial.

“We regularly get asked ’Why was the study set up in this way? Why was this decision made?’” he says. “And without having to go through our extensive records and the emails from ten years ago, our impressive corporate memory means that one of us can normally remember.”

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Publications on Aphinity, ALTTO and OLYMPIA trials

APHINITY | European Journal of Cancer (EJC)

APHINITY | European Journal of Cancer (EJC)

Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial

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APHINITY | AACR Cancer Research

APHINITY | AACR Cancer Research

Effect of young age at diagnosis on clinical outcomes and efficacy of anti-HER2 targeted therapy in patients with HER2-positive early breast cancer: Results from the APHINITY trial.

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The APHINITY Trial: Results of the Primary Analysis

The APHINITY Trial: Results of the Primary Analysis

An article published in the New England Journal of Medicine (NEJM) reports that pertuzumab, when added to chemotherapy and trastuzumab, significantly improved the rates of invasive-disease–free survival among patients with HER2-positive early breast cancer.

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The ALTTO Trial: Results of the Primary Analysis

The ALTTO Trial: Results of the Primary Analysis

An article in the JCO reports that adjuvant treatment that includes lapatinib did not significantly improve Disease-Free Survival compared with trastuzmab alone and added toxicity. One year of adjuvant trastuzumab remains standard of care.

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OTHER FSS NEWS

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