A Contract Research Organization (CRO) is a company that provides support to the pharmaceutical, medical device, and biotechnical industries with research services outsourced on a contractual basis. The range of services includes preclinical trials, clinical research, clinical trials management, biopharmaceutical development, commercialization, pharmacovigilance, and others.
For clinical trials, the sponsor (a company that wishes to test the new treatment and determine its safety and efficacy) hires a CRO on a contract. In this case, the contract research organization provides the sponsor with expert advice and guidance, helping it perform the clinical trial safely. That way, a company doesn’t have to hire full-time staff.
The CROs were created to simplify entry into the drug market and reduce costs for companies working on new treatments and medicine in niche markets. Some CROs specialize in clinical trials and assist in moving the drug from its conception all the way to the EMA/FDA market approval.
In this article, you’ll learn more about what CROs do and what type of services they offer.
Pharmaceutical companies create a new drug or medicine intended for eventual commercialization. When the selected treatment is ready for the testing stage and clinical trials, such a company hires a Contract Research Organization to plan, coordinate, and execute the clinical trial.
Therefore, a CRO doesn’t participate in the process of making the drug or treatment. These independent companies serve as a guide through the entire trial and testing process.
Clinical outsourcing happens when a company hires another company consisting of experts and researchers to conduct medical research and assist in realizing medical trials. This allows the sponsor to keep the company’s infrastructure without hiring additional staff. Moreover, by collaborating with a CRO, the medical company receives expert medical testing while saving money and time.
Consequently, an increasing number of pharmaceutical companies nowadays collaborate with CROs and reduce development and research costs.
A CRO can offer different services, but they are most commonly categorized depending on the sponsor company’s needs that should be in line with the contract research organization’s main function. Here are the main four CRO categories:
Depending on the nature of the contract ad type of CRO, the company roles vary accordingly. Nevertheless, in terms of clinical trials, contract research organizations are in charge of planning, setting up, and day-to-day management and execution of different trial stages.
One of the largest parts of CRO’s job consists of supervising the technical side, collecting data, and the medical testing process. Moreover, CRO plays a vital role in connecting the sponsor with other stakeholders, such as regulatory agencies, vendors, hospitals, ethics committees, etc. Therefore, it’s essential that the work a CRO does complies with the standards and rules imposed by GCP (Good Clinical Practice).
The entire process of device and drug development and the need to rapidly introduce the product to the market to beat the competition and meet the customers’ requirements puts a lot of pressure on the production companies. That’s why a growing number of sponsors partner with contract research organizations.
The CROs play a vital role in all the aspects of the development process, from the discovery to launch. However, they primarily focus on Phase I, II, and III of clinical trials that can take anywhere between three and six years. By nature, trials imply a vast selection of activities, including protocol design, material preparation for the FDA submission, etc.
So, rather than hiring in-house experts to do all the work, sponsors employ a CRO and transfer their responsibilities in writing. It’s a crucial step as all CROs are legally liable for carrying out all the tasks. However, the sponsor is still responsible for the accuracy of all data provided by trials.
For example, an X company wants to create a new drug that helps relieve anxiety, but it doesn’t have in-house staff to design, develop and test the drug. So, the X company hires a Y company — a CRO. Then, the Y company takes part in all the phases, including the pre-clinical laboratory research phase.
When it’s time to start the trial, the CRO will recruit patients for all the trial phases. The CRO will also need to understand how the body reacts to the drug and see if any side effects appear. Before the drug is submitted for approval by the FDA, the CRO will collect and analyze the data and prepare the study results.
Even after the drug obtains approval and is launched to the market, the CRO will keep evaluating and testing the drug’s safety and efficiency.
Just like the type of CROs vary, so do the services. Most commonly, the companies offer the following:
Certain CROs will offer a wide range of services. On the other hand, some CROs focus on specific areas and collaborate with a certain client type.
The most obvious advantage of outsourcing a CRO is that the company solely focuses on the development process. At the same time, the CRO does everything else, including all the stages of clinical trials.
Moreover, delegating these tasks that imply project management, data collection, and patient care to a CRO with previously established systems seems like an attractive and efficient solution to most sponsor companies.
Finally, hiring a CRO saves resources — namely money and time. With a CRO at the company’s side, the clinical trials require less time, and the sponsor lowers overhead costs and expenses.