Contract research organisations (CROs) are becoming increasingly important in the pharmaceutical industry. These organisations provide research and development services, enabling medicine companies to bring their products to market faster and more efficiently.
But when is it necessary to work with a CRO? What are the benefits of doing so? In this blog post, we’ll look at when it’s required to work with a CRO and examine some of the advantages of working with them.
From helping you get FDA approval for your medicine faster to saving you time and money in the long run, plenty of benefits come with working with a contract research organization.
What is CRO?
Contract research organisations provide various services to pharmaceutical and biotechnology companies, including clinical trial management, data management, and biostatistical analysis. CROs (contract research organisations) can also provide regulatory affairs support, help with patient recruitment, and market research. In addition, CROs often have access to specialized laboratory facilities and equipment that can be used for medicine development and testing.
When should you work with a CRO?
There are many instances where working with a CRO can be beneficial. If you are a small company without an in-house research team, partnering with a CRO can give you access to the resources and expertise you need to get your product to market quickly and safely.
Likewise, if you are developing a new product or therapy that requires specialized knowledge or equipment, working with a CRO can help ensure that your product meets all regulatory requirements.
In general, it is often most efficient and cost-effective to work with a CRO when:
- You lack the internal resources (e.g., personnel, expertise, or equipment) needed to complete the project.
- The project is complex and/or time-sensitive.
- You need access to specialised knowledge or equipment.
Where is CRO used?
The clinical trial’s lifecycle is planned, coordinated, carried out, and managed by the CRO safely and efficiently. In addition to acting as the principal point of contact between the sponsor and other stakeholders throughout the trial, the CRO interacts with vendors, medical specialists, research coordinators, regulatory staff, ethics and compliance committees, and vendors.
Clinical trial management includes the following components:
- The first step in clinical trial management services is to assist the sponsor with clinical study design. This might entail creating the entire protocol from scratch or reviewing and offering feedback on the sponsor’s draught protocol.
- Another service provided by clinical trial management companies is site viability. The CRO’s responsibility is to find clinical research sites that will participate in the trial. Depending on the trial period, this service might take a while.
Finding websites with relevant experience and getting in touch with them to find out about their interest in and access to resources requires a lot of tracking and follow-up.
- One of the primary services provided by a CRO is project management. By assessing project metrics and timelines, putting corrective measures in place, keeping an eye on study budgets, managing third-party vendors, and developing an all-around trustworthy relationship with the sponsor, the project management service ensures that the project is carried out as intended.
- Monitoring services are heavily utilized during clinical trials. The sites’ main points of contact are the CRAs (clinical research associates) or trial monitors.
CRAs frequently communicate with the sites to review project timelines and expectations, discuss study updates, AEs/SAEs (adverse events/serious adverse events), assist with study supply needs, and provide general support. This is done to ensure that the sites believe their involvement is significant.
To make sure the protocol is followed and to look for data errors, the CRAs visit the sites.
- A CRO may be hired to offer medical monitoring services. Medical monitoring services ensure patient safety during clinical trials. In addition to reviewing adverse events, concurrent medications, and safety data, medical monitoring services offer 24/7 availability to project teams and sites for safety-related questions.
- The data, analysis, and reports from the clinical study are delivered to the sponsor by biometrics services. Among the services provided is the creation of the data collection forms, software programming to guarantee accurate data entry into the system, statistical programming and analysis, and writing of the sponsor’s final clinical study report.
When working with a CRO, it is essential to understand when and why you may need to seek out their services. Each situation will be different, but some of the most common scenarios include medicine development processes, clinical trials, or medical device approvals.
With the right set of skills and resources, a CRO can provide invaluable assistance in navigating these complex processes. Choosing when and how to work with a CRO depends on your individual needs and goals.
Alicia Saxon did her degree in psychology at the University of Hertfordshire. She is interested in mental health, wellness, and lifestyle.