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Pros and Cons to Working with a Mid-Size CRO

June 16, 2021

The complexity of running a clinical trial requires the involvement of various experts to ensure its success, and this often includes partnering with a clinical research organization (CRO). When the right CRO is chosen and a strong partnership is formed, the benefits of their assistance can be substantial. Therefore, it is important to carefully select a CRO, to analyse the options, and to weigh the strengths and expertise of each CRO.

Pharmaceutical and biotechnology companies are looking for partners who can deliver reliable outcomes, and who will add meaningful support to their research. Many of these biopharma companies default to choosing a large CRO, assuming that their size connotes a level of expertise and superiority within their industry. While it certainly may be the case that a large CRO is the right choice for some trials, it may not be the best choice for all projects. 

While some may think it is risky to work with a mid-size CRO, it may in fact be the more cost-effective and reliable solution. Here we explore the question of whether a mid-size CRO can be the right fit for your clinical trial. 

What makes biopharma choose large CROs? 

Large CROs have become increasingly competitive in recent years as they take on a larger share of the market. This is in part due to the trend of mergers and acquisitions in the industry, which brings together the robust expertise of key operations people across companies and empowers them with access to the latest technology. As these CROs have grown in size, they’ve been able to enhance their service capabilities and reach an international market, all of which has improved brand recognition.

But alongside these advantages, there are some challenges to working with large CROs. For small and medium-sized biopharma companies, the high budgets of large CROs may be prohibitive. Furthermore, within a large CRO there are many divisions and teams, with varying levels of expertise, and there’s no guarantee of being assigned the top team on any given project. In some publications, including Pharmaceutical Outsourcing\(^1\), it has been suggested that the top teams are reserved for the top clients, which can present a challenge for new and emerging smaller biopharma companies.

Another challenge associated with working with a large CRO is that the size of the organization can introduce bureaucratic hurdles. There may be multiple points of contact which can lead to miscommunication and confusion. Employee turnover may also be a problem at larger CROs\(^{2,3}\),and can disrupt the continuity and teamwork of the clinical trial.

Unique Advantages of Mid-Size CROs

For biopharma companies that struggle with these challenges of trying to work with a large CRO, a mid-size CRO may be the better choice. A mid-size CRO is more accessible and affordable, which makes them particularly attractive for start-up biopharma companies. Being smaller makes these CROs more nimble, and able to meet the distinct needs of their biopharma clients. And yet, mid-size CROs are still large enough to manage a complex international clinical trial, which may be out of scope for a small CRO.

Furthermore, most mid-size CROs are founded by individuals or groups of scientists with expertise in a specific therapeutic area, and are therefore well-positioned to be the strongest partners in their specific market. This narrow focus within a niche specialty is a unique advantage of mid-size CROs, which is not possible within the broad scope of a large CRO.

With a mid-size CRO, biopharma companies receive individualized attention, and a team can quickly be assembled that has the right experience to match the project. Collaboration is easy because there is a single point of contact, which provides personalized and flexible service. Furthermore, senior management is much more accessible, which helps with the decision-making process and ensures strategic company-level oversight, compared to large CROs. Given this personalized approach, working with a mid-size CRO often feels like an extension of the biopharma company’s team, and this can lead to a long-lasting collaborative relationship.

Risks of Working with a Mid-Size CRO

Given the strong presence of large CROs in the industry, biopharma companies may assume that working with a mid-size CRO is risky. One concern is that mid-size CROs may reach a critical point at which they don’t have the internal resources or geographical coverage to manage larger international projects. Although this does not apply to most clinical trials, when it does, it can be effectively managed by connecting with qualified vendors and contractors to assist with the services that aren’t covered by internal resources. The mid-size CROs that have a strong track record of managing international trials will have many potential partners within their network to leverage for trials as needed.

Therefore, although CRO size does matter, the choice of CRO must ultimately be based on a thorough assessment of the CRO’s strengths, limitations, and potential risks. Such an assessment should include careful review of the CRO’s financial stability, their pricing relative to the market, their operational procedures, their regulatory compliance record, the expertise of the CRO’s personnel, and their capabilities based on track record. Biopharma companies should also assess the specialization of a CRO in terms of their services or therapeutic area, to match the needs of their trial. Ultimately, there is not a one-size-fits-all solution for the successful implementation of clinical trials, but sponsors should feel confident in considering a mid-size CRO to partner with on their next clinical trial, given their unique advantages over large CROs.

Why choose Dokumeds?

Dokumeds is a mid-size CRO led by an expert dedicated team of physicians with over 25 years of industry experience. Dokumeds’ well-designed workflow management system and expertise in handling diverse projects across different geographies has led to a consistent quality of services for Dokumeds’ clients. As a mid-size CRO, Dokumeds is uniquely positioned to provide flexibility and tailored solutions to each project’s individual needs.

Dokumeds has been internationally recognized for their capabilities to conduct clinical trials on budget and on time, as well as their regulatory expertise and legal competence. Dokumeds has worked on different scopes of studies, ranging from 1 site and 1 subject up to covering over 10 countries, with over 100 sites, and over 3,000 subjects. Dokumeds’ international clinical trial management experience provides the ability to cover clinical trials in 4 geographical regions: Europe, Africa, Latin-America, and Asia. The endorsement of Dokumeds’ partners is evident from Dokumeds’ repeat business rate of over 80%. Dokumeds’ success is attributable as much to resources and expertise, as it is to the relationships built with Dokumeds’ biopharma partners. Dokumeds looks forward to partnering with small and mid-size biopharma companies on their new clinical trials.

References

  1. Finding the one: how to choose a clinical partner from a sea of service providers. Pharmaceutical Outsourcing. https://www.pharmoutsourcing.com/Featured-Articles/564708-Finding-the-One-How-to-Choose-a-Clinical-Partner-from-a-Sea-of-Service-Providers/. Accessed 8 June 2021.
  2. Static salaries, lack of opportunity blamed for five-year high in U.S. CRO trial monitor turnover. CenterWatch. https://www.centerwatch.com/articles/24515-static-salaries-lack-of-opportunity-blamed-for-five-year-high-in-us-cro-trial-monitor-turnover. Accessed: 8 June 2021.
  3. CRO workforce turnover hits new high. The Association of Clinical Research Professionals. https://acrpnet.org/2020/01/08/cro-workforce-turnover-hits-new-high/. Accessed: 8 June 2021.

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