Collaborating with a contract research organization (CRO) is now an essential and significant step for biotech and pharma companies during the clinical development process. Outsourcing clinical trials to a CRO is seen as an attractive option for sponsored pharmaceutical research. Among the reasons why any biopharmaceutical sponsor would outsource their projects would be the higher therapeutic expertise in the contracted company, resource management, technological advantages and as a way of cutting some of the many costs associated with clinical research.

This has fueled the CRO industry and led to tremendous growth in the number and size of CROs. Many of these CROs position themselves as offering the complete range of services needed for the drug development market. However, based on the study-specific requirements, many smaller and niche biopharmaceutical companies subcontract for their functional needs. This provides smaller CROs the opportunity to provide a more niche approach to its clients, particularly smaller sponsors who have shared synergies.

The two distinct and basic models of collaboration remain as outsourcing to a full-service CRO and functional outsourcing to specialized vendors. In full-service outsourcing, all the essential functions such as data management, clinical operations, medical management, project management, statistics, medical writing, regulatory and, in some cases, pharmacovigilance are outsourced to a selected CRO. In functional outsourcing, specific services among those listed above are outsourced to different, specialized service providers. The decision to opt for full-service or functional outsourcing at most times depends on the available in-house capabilities and phases of clinical development.

For each individual project, the expertise of the core team and the efficiency of ground operations are significant in determining the successful conduct of the study. Both are dependent more on the expertise of the team members themselves regardless the size of the provider that they belong to. The tools utilized to manage aspects of trials may differ, but the team’s skills are more critical for any study run.

The retention rate, however, is a real challenge for the industry and, regardless of the size of the CRO, turnover within a study team is disruptive to the workflow. Surveys cite a growing rate of overall turnover in CROs, a trend which is skewed towards the higher turnover of clinical trial monitors. This highlights the importance that CROs must place on maintaining the stability of the study team, retaining its skills and preserving its structure as essential factors for achieving the objectives with high quality and in a timely manner.

The variability of core competencies between the CROs should also be considered during the selection process. For instance, some CROs will have substantial therapeutic expertise, while others may boast an unmatched global reach, still others might have strong patient recruitment strategies. Thus, when a specialized study is planned in which all of these are essential, it might be more efficient to opt for selective functional outsourcing where functional components are contracted to specialized partners that have a niche capability in each contracted service.

For key functions like data management, statistics, medical management and pharmacovigilance, experience of the team and its members should be focused on during the selection process. For other functions that require ground operations like clinical monitoring and regulatory, providers with a more global footprint and local access would prove advantageous. Though strategic partnership denotes a full-service collaboration, in reality, most CROs are flexible to offer both tactical and strategic elements to a sponsor based on the demand. Hence, a flexible and well-mapped strategic collaboration based on skills, capabilities and expertise, can incorporate the best of both worlds by defining the goals and performance-based modelling.

As each study is unique, a tailored approach with built-in flexibility is essential. Accordingly, the principle of ‘one size fits all’ is not pragmatic from an operability perspective. A project-specific, dual approach of outsourcing models can prove highly efficient for sponsors, where a clear distinction is made between the functions that can be centrally delivered with distinguished expertise, high efficiency, cutting-edge tools and methodology, and services that require ground operations with local experience and regional reach.

Streamlining these services could be a challenging task for the sponsor, as there are often different providers coming together for a study. However, this integrated approach introduces transparency, enhances quality and gives more control to the sponsor from a study management perspective. With the growing CRO market expected to reach $45.2 billion by 2022, it is critical for sponsors to understand the evolution within the fabric of the outsourcing partners and garner the best sources for their development needs.¹

The European biotech industry is booming with more than 1,000 biopharma companies with their headquarters based in Europe and investment in European biotechnology increasing from $5.8 billion to $7.7 billion in the period 2017 to 2019.^2,3

At Europital, we have seen that small innovators in the UK and continental Europe have a clear need for a science-focused CRO that can bring detailed knowledge and therapeutic experience to their projects, especially during early development such as in First-in-Human, Phase I and Phase II studies where the go/ no go decision is critical. With advances in biological science and novel targets and candidates from smaller biotechnology and academic spinoffs, this demand for early clinical development services is growing. Gaining access to senior medical CRO expertise, however, can be extremely challenging for these smaller innovators as there is a real shortage of senior experience in the market due to the sheer number of trials underway. What these small pharma and biotech companies need is a partner who brings a medical department with real-world trial experience to become a scientific driving force and powerhouse behind the project’s study design, execution and ultimate success.

We have found that sponsors from niche to midsized biopharmaceutical organizations might experience challenges, not only in attracting bigger CROs, but also in getting the CRO’s highly skilled and senior personnel that they need (and have often been presented in the sales process) to be appointed to their projects. A large proportion of emerging pharma companies have also cited unexpected charges, the timeliness of resolving issues and product quality as reasons for dissatisfaction with their respective service providers. A common trend that we have noticed is that small biotechs with previous experience of working with a large CRO choose instead to work with small providers who have expertise in their respective domains in subsequent projects. This is especially the case during the early development phase where the geographical scope of the study is somewhat limited and operational presence in different continents is not required.

The dynamic shift in outsourcing methodology and service fragmentation has left companies with critical decisions to be taken at the juncture of CRO sourcing. Although this increases the workload for vendor management for these smaller companies, they find that their project receives a more quality service, which results in higher quality research and so, ultimately, leads to a higher return on investment.

The trend that we have observed is that in this process of looking for a CRO, the sponsor will often reach out to providers where they can have a greater influence on the requirements and deliverables. This is where most opportunities are created for small and niche providers. Small- and mid-sized CROs might not have a global reach or competitive technology compared to the largest. Still, they can cater to the needs of their clients in a more personalized manner and, therefore, successfully provide their niche service and expertise in project-based or tactical collaboration.

The UK is an increasingly attractive and competitive location to perform clinical studies. In the year 2018 to 2019 alone, more than 870,000 people took part in clinical trials across England. We were therefore happy to open our latest office in Oxford earlier this year as Oxford is one of the most rapidly growing hubs of drug discovery and medical device development in the UK.

The Oxford Biotech Cluster is a mature epicenter of life science research companies and one of the three closely situated regions in the UK known as the “Golden Triangle.” This Golden Triangle accounts for more than a third of biotech companies in the UK and is responsible for receiving more than 60% of the share of investment in the whole of the UK’s life sciences industry.

Since 2010 the number of diagnostics and therapeutically focused UK biotechs that have been founded has grown steadily from 14 in 2010, to 29 in 2017.⁴ While Brexit has caused a sharp decline in the number of newly founded biotechs, the amount of venture funding for UK based biotechs has remained steady over the last five years hovering around the $1.1 – $1.2 billion dollar mark each year, with only 2019 experiencing a more significant drop in funding to around the $716 million mark. While this investment in UK biotech has been affected by Brexit, the UK is still the largest country in Europe for life science research. Now, as the UK prepares to withdraw from the European Union under uncertain terms and conditions, the presence of a Europital office in the UK is also of strategic importance and a reassurance to the concerns of sponsors in the research industry.

It’s a really exciting time for innovators in the UK and the biotech hubs have a vibrant pipeline of candidates. But, much of this cutting-edge innovation lies with smaller companies and spin-outs that need the help of a science-driven CRO—not a volume-driven, large CRO that usually won’t give the study the attention it needs.

A significant window for improvement still exists in the way different functions of trial management are integrated to reach shared goals. More than the size of the provider, therapeutic expertise, efficiency, transparency, and standardized technology are critical in determining the successful conduct of a clinical trial. The sponsor needs to balance their expectations and resources to decide upon the outsourcing model to be adopted for a particular study or development program. 

References

1. Healthcare Contract Research Organization Market Size, Share & Trends Analysis Report By Type (Drug Discovery, Pre-Clinical, Clinical), By Service (Clinical Monitoring, Data Management), And Segment Forecasts, 2020 – 2027. Grand View Research, published: Feb, 2020.
2. Biopharm Insight (http://www.biopharminsight.com/)
3. Cormac Sheridan (2020) European biotech edges to new investment high of $7.7B in 2019. Available online: https://www.bioworld.com/articles/432168-european-biotech-edges-to-new-investment-high-of-78b-in-2019 (Accessed: 23 October 2020).
4. UK Life Sciences Trend Analysis 2020. Available online: https://resourcecenter.biotechgate.com/2020/01/uk-life-science-market-trend-analysis-2020/ (Accessed: 23 October 2020).