CRO’s are companies that do specific types of experiments or studies for a fee.
According to one report, the global market for Contract Research Organizations (CRO's) will rise to over $45 billion by 2022, up from approximately $37.8 billion in 2017. Companies of all sizes in the life sciences industry are taking advantage of this research tool to increase their chances of success. However, there's more to working with a CRO than meets the eye. Follow our guide to make sure your CRO collaborations go smoothly.
For any biotech or medtech company, working with CRO’s can be an efficient use of resources. They allow companies of any size to outsource work that would otherwise require significant capital to do internally. CRO’s are companies that do specific types of experiments or studies for a fee. They generally do not assert any ownership over the intellectual property involved while providing access to technical expertise. CRO's let you avoid buying expensive equipment and hiring or training staff for a short-term project.
Companies frequently use CRO's to run clinical trials, as they require a highly specialized skill set. In fact, CRO is sometimes used to mean "clinical research organization." For a company taking a drug or device into the clinic for the first time, clinical research organizations can provide an entire team of experts that the company would otherwise have had to hire. Additionally, many companies prefer to run their first clinical trials countries where the administrative burden and costs are lower. Clinical research organizations in those countries have the "home field advantage" and therefore can simplify the process.
An earlier-stage company might use a CRO to run their animal studies if they do not have access to a vivarium, or to develop a new cell line. Some startups even choose to run their initial studies entirely through CRO's and forego a laboratory of their own until they have more funding. (This is often called a "virtual startup.")
Because there are so many CRO's all over the world that collectively perform a huge variety of services, directories or marketplaces can be a great way to find the right CRO for your needs. Biocom, a life science association in California, has developed its own CRO directory that is organized into twelve categories. Science Exchange is an online marketplace for CRO's with additional functions. They will take an active role in managing your CRO collaborations if you choose their Enterprise option. Scientist.com uses a similar model to Science Exchange, with the addition of AI technology. Many researchers and companies prefer to find CRO's based on personal recommendations. You'll find that those who have had good experiences with a CRO are happy to share.
Communicate your expectations clearly. This may seem like a no-brainer, but we don’t just mean telling the CRO what experiment you expect them to do and for how many samples. We mean communicating how often you want updates and what occurrences would be reason to consult you. Other points that should be discussed up front include, what level of input do you want from the CRO? We recommend utilizing the experts at the CRO as much as possible. Yes, you are the expert on your product, but these folks have seen many drug candidates/biologics/medical devices over the years and probably have some great recommendations on protocol design.
Agree on a method of communication between your employees and the CRO. This might seem like a minor detail, but not having a communication strategy can significantly impact your collaboration. You’ll want to know who you need to talk to regarding different aspects of the project, and how they prefer to communicate. Maybe the legal team responds better to phone calls and the quality control team already uses a specific software to which they can provide temporary access. Planning your communication methods might even mean investing in a cloud-based software solution for secure data sharing. Ideally both teams will agree on what methods of communication to use, so no one will go through the frustration of searching through old email attachments.
Define roles and responsibilities for everyone on the team. When we say “team,” we mean everyone working on this project, whether they are your employees or the CRO's. It’s important for everyone to know who is accountable for what. You want each team member to understand their deliverables. Plus, you want members to know who can address specific questions on different aspects of the project. We've all sent an email starting with, "I'm not sure if you're the right person to answer this, but..." Again, this might seem like a minor detail in the grand scheme of a study, but it saves time and confusion throughout the project.
Agree on what will happen if there’s a problem. A problem might be within the study itself, such as the initial data points going in a different direction than expected, or there might be a supply-chain issue. Regardless, you need a method for addressing potential situations that both sides have agreed upon ahead of time. This will prevent communication from breaking down and it will make obstacles easier to overcome. Things to remember when addressing problems are to avoid apportioning blame and to promote constructive feedback. Having a framework already established will help your team solve issues efficiently and keep everyone moving forward toward your common goal.
Create a positive culture within your team. In order for your collaboration to work well, it’s important to make interactions positive and transparent. Just as unhappy employees tend to produce sub-par work, unhappy collaborators will tend to put less effort into your study. Creating a positive culture means providing all the information that your team needs to do their work, being responsive to communications, and promoting an open and productive sharing of ideas. The CRO you partner with may have improvements to make on your protocol. They might have an excellent data sharing system that you've never tried before. They could even have a team culture that you admire and wish your company could emulate. By being open to learning from your collaborator, you may benefit in areas beyond just the study at hand.
You may have noticed that the above methods for setting your CRO collaboration up for success have a related theme: Communication. That's because whenever you are working with others, what, when, and how you communicate is going to affect the outcome. Although it is an over-used stereotype, sometimes scientists do need to be reminded of this fact (yours truly included.)
Additionally, we suggest that the best way to utilize a CRO is to treat them as an active partner in your project. Then you can take advantage of the CRO's expertise, manage expectations, and react quickly to necessary changes. All of this together will save you time and money, which is usually the reason you’d choose to work with a CRO in the first place--because it’s cheaper and easier than doing the work yourself.
Using these methods will help you get the most out of your collaborations with Contract Research Organizations. If you have other CRO-related tips that might help biotech and medtech startups, please share them below in the comments!
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