Working with a Mid-Size CRO: What should you keep in mind?

Working with a Mid-Size CRO: What should you keep in mind?

The success of a clinical trial hinges on partnerships between experts and other stakeholders, such as a clinical research organization (CRO).  Pharmaceutical and biotechnology firms are seeking alliances with viable entities to achieve substantial outcomes. Thus, the selection of a suitable CRO remains a fundamental process to successful clinical trials. Such a process may encompass evaluating the capabilities of every CRO as well as the available alternatives. While there is a widespread misconception that large CROs are superior, the level of expertise and superiority may not entirely depend on their size.

Contrary to the widespread misconception that associates mid-size CRO with heightened risks, working with such entities may prove cost-effective and reliable. This article delves deep into the viability of mid-size CRO in clinical trials.

Mid-Size CROs Exhibit Unique Advantages

A mid-size CRO may be a better option for biopharma firms, which can experience challenges in working with large CROs. Mid-size CROs exhibit distinctive features, which make them attractive for specific biopharma organizations. They are affordable and accessible and are therefore suited to address the specific needs of their biopharma customers. Fortunately, such mid-size CROs are well equipped to handle complex international clinical trials beyond the reach and capability of their smaller counterparts.  

Moreover, mid-size CROs derive their strength from their formation, particularly by individuals or groups of specialists with expertise and experience in a given therapeutic area. In doing so, these organizations are more attractive as more feasible partners, especially in their niche. The narrow focus on a specific market presents enormous advantages to the midsize CROs, unlike broad focus, where they can encounter significant limitations compared to their larger counterparts.

Biopharma businesses benefit from collaborating with mid-sized CROs due to the broad array of benefits attributed to the latter. One notable feature is getting specialized attention and flexibility in assembling the team with the relevant expertise to conduct a swift clinical trial. Communication is effective, and coordination is made easier by the single point of contact that offers customized and agile services.

Unlike larger CROs, mid-size CROs exhibit flexibility in decision-making and general management, an issue attributed to accessibility. The leadership of such CROs can ensure strategic oversight and personalized services, which make them suitable for a harmonious and potential long-term collaboration with biopharma companies.

Why Biopharma may select Large CROs

Large CROs have an advantage of larger market share and have since become increasingly competitive. One of the primary reasons behind such a trend is the pursuit of mergers and acquisitions, which brings together a large pool of expertise and experience coupled with advanced technology. Therefore, such CROs have managed to access the global market and increase their international presence, enhancing their brand recognition.

However, working with these organizations is not a free ride. One notable limitation is the relatively huge budgets that tend to discourage small and medium-sized biopharma. Besides, coordination and work assignment is unpredictable due to the many teams and divisions. Thus, you are not assured of a top team to work with on a given project. Some articles, such as Pharmaceutical Outsourcing1, have speculated that the best clients are allocated the best teams, posing a significant challenge to the new and growing smaller biopharma businesses.

Also, the bureaucratic nature of large CROs presents significant challenges, especially in the communication and coordination of projects. Such organizations often experience high turnover rate2,3, thereby compromising the operations of clinical trials.

Risks of Partnering with Mid-Size CRO

Working with small-sized CROs may be deemed risky due to their small market share. A major concern is the limitation of these organizations in managing large international projects due to resources or geographical coverage. Nevertheless, such an issue can be addressed by engaging contractors and qualified vendors when such a need arises. Mid-size CROs with a proven record of managing international trials are likely to have many potential partners at their disposal in case of any international trials.

There is a need to prioritize CRO’s strength, potential risks, and limitations while assessing their partnership capability, not entirely based on size. A careful review is necessary, encompassing CRO’s financial stability, pricing, operational procedures, regulatory compliance record, the expertise of their personnel, and performance record. There is no universal answer to the effective execution of clinical trials, though funders may find it prudent to work with small-size CROs due to their benefits.

Why should you use Dokumeds?

Dokumeds is a mid-size CRO with experienced and highly qualified physicians. Their experts boast more than 25 years’ of experience and provide a complete range of clinical operations services, irrespective of the treatment niche. Dokumeds offers exceptional services to clients due to its excellent workflow and experience in managing a wide range of international projects. As a mid-sized CRO, Dokumeds is flexible and offers customized solutions to meet the specific requirements of each project it undertakes.

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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Nicolas Desjardins

Hello everyone, I am the main writer for SIND Canada. I've been writing articles for more than 10 years and I like sharing my knowledge. I'm currently writing for many websites and newspapers. All my ideas come from my very active lifestyle, every day I ask myself hundreds of questions to doctors, specialists, and physicians. I always keep myself very informed to give you the best information. In all my years as a computer scientist made me become an incredible researcher. I believe that any information should be free, we want to know more every day because we learn every day. Most of our medical sources come from Canada.ca and government research. You can contact me on our forum or by email at info@sind.ca.

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