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With technology advancing at such a fast rate, pharmaceutical companies and medical technology manufacturers have huge opportunities to develop groundbreaking treatments that transform the lives of patients across the globe. This is a powerful position to be in, and a lucrative one. But for every headline that’s published to announce a new medicinal breakthrough, there are many more years of work that have gone on behind the scenes.
Advances in medicine certainly don’t happen overnight. Instead, they require a dedicated team that’s committed to carrying out hours upon hours of research to develop and test the drugs before they’re put forward for approval. This painstaking process of organizing and overseeing clinical trials is often complex and challenging to manage. However, this is understandable due to the importance of ensuring that drugs are robustly tested and deemed safe and effective before being made available to the general public.
While the manufacturer’s name will obviously be listed in the final study report, this doesn’t mean that the manufacturer will manage the entire clinical trial themselves. The research itself could be commissioned by a medical device manufacturer or a pharmaceutical company, but then outsourced to an external company. There are many reasons why this happens. Often, these organizations may not have the resources or appetite to manage their clinical research themselves. This is why contract research organizations, aka clinical research organizations (CROs), are often used, and the manufacturer becomes the sponsor, while retaining overall responsibility for the clinical trial.
Keep reading to understand more about the role of contract research organizations and why they’re so important for modern clinical research.
What Does a Contract Research Organization Do?
Many people assume that pharmaceutical companies, biotech firms, and medical device manufacturers are so big that they simply carry out all their research in-house. However, the research element of new drug and device development is often outsourced to a contract research organization (CRO). Here’s how the CRO helps to facilitate research:
Recruit Trial Participants
CROs often take charge of identifying suitable clinical trial participants on behalf of the sponsor. The CRO will usually start by identifying potential participants to recruit for the trial. Once patients are recruited, the CRO will guide them through the enrolment process, answering any questions they may have. Once patients are recruited to the trial, the CRO will then implement their patient engagement strategy to manage them during the clinical trial. Taking a patient centered approach to the trial is essential to ensure high retention rates throughout the duration of the research. Effectively managing patients to ensure that they remain engaged and committed to the trial is a time-consuming task. This is one key reason that sponsors choose to outsource their trials to CROs with the experience and proven patient engagement strategies needed to retain participants.
Selecting Appropriate Sites
Identifying and recruiting the right patients to a clinical trial is essential to achieve meaningful results. But one task that is equally important is selecting the most appropriate site for the clinical trial to take place. CROs often take on the role of finding the ideal site to use for trials. This is no small task, as the chosen site can directly impact the success of the trial. This requires CROs to identify multiple potential sites and to then assess the feasibility of the site to decide whether it is the best location to host the clinical trial. Some CROs already have a list of potentially usable sites ready and waiting to access. Having a choice of sites already identified and ready to use can significantly reduce the time it takes to get the trial set up and started.
Oversee Documentation
For research to be respected and taken seriously all the paperwork needs to be completed to regulatory standards. This can be a time-consuming process and requires many elements to be taken care of before, during, and after the trial is completed. The CRO will take on this often complex task, which involves documenting data throughout the clinical trial, reporting on the efficacy of the drug or medical device, and producing the final report.
Preparing Final Analysis for Global Markets
Documenting the trial results is the final stage of the long process of clinical research for new products and medical devices. However, this isn’t a task that should be rushed. It’s vital that the CRO carefully prepares the final study report. If the study results are to be published in international journals, it’s essential that they are translated into multiple languages. But trying to translate research papers yourself is unlikely to be as successful as you hoped. There’s no room for error when sharing research reports. So, it’s important to seek the assistance of a professional translation service that offers linguistic validation. Ensuring that the documents are translated accurately and that regulatory compliance is met is a must.
Why Are Contract Research Organizations Important for Modern Medical Research?
Contract research organizations are increasingly playing a big role in medical research. Here are some of the reasons that they’re so important:
Reducing Time to Market
Getting new medications to market as quickly as possible is a must for patients to benefit from new treatments quickly, and for manufacturers to ensure they stay ahead of the competition. A CRO can make this happen by solely focusing on the management of the clinical trial.
Cutting Costs
Hiring an in-house team to carry out clinical trials is a significant expense for manufacturers. Outsourcing to an established CRO can cut costs and ease the workload on the manufacturer, leaving them to focus on the development of new treatments.
Providing Experience and Expertise
Finally, CROs should provide pharmaceutical companies with the experience needed to meticulously manage the clinical trial on their behalf, bringing their extensive expertise to the trial. This can relieve pressure at every stage of the trial for the pharmaceutical company by removing many of the time-consuming and complex processes involved in trials, such as recruiting patients, compliance, and delivering the final study report and associated documentation.
