Contract Research Organizations have seen a rise in popularity in the Life Sciences industry in recent years.
But, before we go into the facts and figures, let’s take a moment to really delve into what a Contract Research Organisation (CRO) is and what they do. A CRO is basically what it says on the tin – they are specialised research services for the Pharmaceutical, Biotechnology and Medical Device sectors that work on a contract basis.
A CROs role during clinical trials is to ensure strict vigilance during all stages of the clinical trial process. For data integrity and human subject protection, laws, regulations, and industry standards must be adhered to.
Pharma companies outsource to CROs for various reasons. Staying competitive and flexible is essential; especially as technology develops, knowledge is growing exponentially, and the economic environment is unstable.
There are 6 phases carried out during a clinical trial, these are:
CROs can be involved in any of the phases. They can either be part of the full cycle of the trials or bought in for one phase, depending on the requirements of the Sponsor.
There are various trials carried out, these include broad trials of drugs, devices, and procedures. As with most sciences, there are subcategories within each trial – they could be looking at preventions, diagnostic, treatment, and/or epidemiological trials. Therefore, a strict program needs to be adhered to – this is where the use of a CRO comes in.
The global CRO industry saw growth in the years up to 2018 by approximately 8%, reaching around $37.1 billion.
Then 2020 hit, there’s no need to mention the “C”word, we all know what I’m talking about!
There were approximately 62,000 trials started between February and May before the pandemic, of which only 57% would have occurred if there had been no pandemic.
As with any other company at that time, CROs also had to adjust their working methods during this period. Despite the pandemic’s impact, it was not entirely negative. It forced suspension of trial activity or its discontinuation, thereby reducing revenue, but also provided an opportunity to grow, whether it be by making an acquisition or changing from a jack-of-all-trades to a niche-specific entity. For example, some CROs adapted the way they conducted their trials. They managed to change their processes so they could be conducted at home. This not only enabled the trials to continue in an uncertain world, but also enhanced patient engagement efforts.
The number of clinical trials has increased significantly over the past couple of years. As of September 2021, there were around 390,000 studies registered globally.
How can Sponsors benefit from working with CROs? In a nutshell – they can save the company a lot of time and more importantly money! Have a CRO as part of the clinical trial program, and the Sponsor can delegate all their duties and functions to them, giving the Sponsor time to operate a drug development program when otherwise they might not be able to.
CROs already have the resources in place – clinical trials are complex exercises in project management, collaboration, and clinical patient care. To effectively conduct these trials, a Sponsor can rely on the CRO. With the necessary resources, CROs are prepared to move forward quickly, and of course, time is of the essence with clinical trials. If the Sponsor had to create and acquire everything themselves, the project would suffer considerable delays. When you use a CRO, the time needed to get a trial up and running is significantly shortened.
With CROs working globally, Sponsors can use that to their advantage if the requirement is needed to develop an application to market a drug in a different country. To distribute said drug in said country, the research must be carried out in that specific country. Thus, a Sponsor can select a CRO with research facilities and teams across the globe, meaning it gives them immediate access to market their drug in multiple countries.
Over the past couple of years, the FDA have had high drug approval rates. The current record for drugs approved is 59 in 2018. Keeping this in mind – the 2020 pandemic saw 53 drug approvals, and 50 in 2021. Without the help of CROs, this may not have been possible for pharmaceutical companies to deliver their products to the market.
Although delegating all duties and functions to a CRO can be beneficial, it also has its drawbacks. Yes, the program tasks will get completed, but there is no assurance they will be completed properly.
This is an issue, as the Sponsor ultimately holds full responsibility. If there are any issues with anything related to the CROs actions, it is the Sponsor that must face the consequences.
It is hard for Sponsors to keep up with what’s going on through the process – especially if their CRO is based abroad. Day-to-day operations can’t be overseen, and sometimes the line of communication is unclear. This fact raises concerns about the ability to maintain oversight of the entire program.
During the life cycle of the program, multiple audits are necessary. To ensure the Sponsor’s interests are protected, these must be conducted. Audits can include prequalification (ensuring the CRO has the requirements needed), routine audits at points during the trial to ensure the quality of the trial is upheld, and an audit towards the end of the program to ensure it is properly closed. Audits aren’t a con, but more of a must have.
Let’s consider what this means for the Life Science industry. We can safely say it is an ever-growing industry. The analytics market grew at 16% from 2019 to 2021 in two consecutive years.
According to estimates, the market will grow by approximately 7.5%-8.4% each year over the next five years. Clearly, the Life Sciences sector has a bright future ahead, and CROs are a crucial component of their success.
So, if you are a CRO looking for people to join or grow your team, contact a member of the Focus on Lifescience Recruitment Team.