Contract Research Organizations are companies that conduct specific types of experiments or studies for a fee.
According to one report, the global market for contract research organizations (CRO’s) will grow to more than $45 billion by 2022, from approximately $37.8 billion in 2017. Companies of all sizes in the life sciences industry are using this research tool to increase their chances of success. However, there is more to working with a CRO than meets the eye. Follow our guide to make sure your CRO collaboration goes smoothly.
What are contract research organizations?
For any biotech or medical company, working with a CRO can be an efficient use of resources. They allow companies of any size to outsource work that would otherwise require significant capital to do in-house.
CRO’s are companies that conduct specific types of experiments or studies for a fee. They generally do not assert any ownership of the relevant intellectual property while providing access to technical knowledge. CRO allows you to avoid buying expensive equipment and hiring or training staff for a short-term project.
Companies often use CROs to conduct clinical trials because they require a highly specialized skill set. In fact, CRO is sometimes used to mean “clinical research organization.” For companies 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 to hire. In addition, many companies prefer to conduct their first clinical trials in countries where the administrative burden and costs are lower. Clinical research organizations in these countries have a “home advantage” and can therefore simplify the process.
An early-stage company can use a contract research organization to conduct their animal studies if they don’t have access to a vivarium, or to develop a new cell line. Some startups even choose to conduct their initial studies exclusively through a CRO, forgoing their own lab until they have more funding. (This is often called a “virtual startup.”)
Where can you find a Contract Research Organization?
Because there are so many CROs around the world that collectively provide a huge range of services, directories or marketplaces can be a great way to find the right contract research organization for your needs. Biocom, a life sciences association in California, has developed its own CRO directory, which is organized into twelve categories. Science Exchange is an online marketplace for CROs with additional features.
Also read:-Ophthalmology Clinical Trials Step by Step Guide
If you choose their Enterprise option, they will take an active role in managing your CRO collaboration. Scientist.com uses a similar model to Science Exchange with the addition of AI technology. Many researchers and companies prefer to find CROs based on personal recommendations. You will find that those who have good experience with CRO will be happy to share.
5 methods to help your collaboration run smoothly:
Make your expectations clear.
This may seem obvious, but we don’t just mean that you tell the CRO what experiment you expect them to perform and for how many samples. We mean telling you how often you want updates and what occurrences would cause you to consult them.
Other points that should be discussed beforehand include what level of input do you require from the CRO? We recommend using CRO experts as much as possible. Yes, you are an expert on your product, but these people have seen many drug/biological/medical device candidates over the years and probably have some great recommendations for protocol design.
Agree on a method of communication between your staff and the CRO.
It may seem like a small detail, but not having a communication strategy can greatly affect your collaboration. You’ll want to know who you need to talk to about different aspects of the project and how they prefer to communicate.
Maybe the legal team is more responsive to phone calls and the QA team already uses specific software that they can provide temporary access to. Planning your communication methods may even mean investing in a cloud-based software solution for secure data sharing. Ideally, both teams agree on what methods of communication they will use, so no one goes through the frustration of digging 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 it’s your staff or the CRO. It is important that everyone knows who is responsible for what. You want each team member to understand their deliverables.
Additionally, you want members to know who can address specific questions about different aspects of the project. We’ve all sent an email that starts with, “I’m not sure if you’re the right person to answer this, but…” Again, this may seem like a small detail in the grand scheme of the study, but it saves time and confusion throughout the project.
Agree on what will happen if there is a problem.
The problem could be in the study itself, for example the initial data points are going in a different direction than expected, or there could be a problem with the supply chain. Regardless, you need a method for dealing with potential situations that both parties agree on beforehand.
Also read:-What Is Gastroenterology Clinical Trials?
This will prevent a breakdown in communication and make it easier to overcome obstacles. When solving problems, remember to avoid apportioning blame and encourage constructive feedback. Having a framework already in place will help your team solve problems effectively and keep everyone moving towards your common goal.
Create a positive culture in your team.
For your collaboration to work well, it’s important that interactions are positive and transparent. Just as unhappy employees tend to produce subpar work, unhappy coworkers will tend to put less effort into your studio. Creating a positive culture means providing all the information your team needs to do their jobs, being responsive to communications, and encouraging the open and productive sharing of ideas.
The CRO you work with can make improvements to your protocol. They may have an excellent data sharing system that you have never tried before. They may even have a team culture that you admire and wish your company could emulate. By being open to learning from your co-worker, you can benefit in areas beyond just studying.
Contract Research Organization with you
You may have noticed that the above methods for setting up your contract research organization collaboration for success have a related theme: Communication. This is because whenever you work with others, what, when and how you communicate will affect the outcome. Although this is an overused stereotype, sometimes scientists (including yours truly) need to be reminded of this fact.
Additionally, we recommend that the best way to leverage a contract research organization is to approach them as an active partner in your project. Then you can take advantage of CRO expertise, manage expectations and quickly respond to necessary changes. All of this together will save you time and money, which is usually why 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 working with contract research organizations. If you have other CRO-related tips that could help biotech and medical startups, please visit our site! Vial
