If you are developing a medical device or in vitro diagnostic and preparing for investigationa clinical investigation or clinical performance study, you will almost certainly come across the term CRO. It stands for Contract Research Organisation and it is a company that provides clinical research services to sponsors on an outsourced basis.
In simple terms, a CRO is an external partner that helps you plan, set up and run your clinical investigation. Depending on your needs, that could mean taking on the entire investigation from start to finish or providing specialist support in specific areas where you need extra resources or expertise.
What Does a CRO Do?
The scope of what a CRO can do is broad. At the full-service end, a CRO can manage every aspect of your clinical investigation including study design, study document writing (protocol, investigator’s brochure, informed consent form), site feasibility, selection, contracting and initiation, regulatory and ethics submissions, data management, site monitoring, safety reporting, biostatistics and interim/final study report writing.
For sponsors who have some internal capability but need targeted help, a CRO can also provide support in specific areas. This might be site monitoring, biostatistics, study document writing, depending on where the gaps are.
For medical device and in vitro diagnostic companies in particular, working with a CRO that understands the specific requirements of device clinical investigations or clinical performance studies is of key importance. They operate under a different regulatory framework than pharmaceutical studies, such as ISO 14155, ISO20916, EU MDR 2017/745 and EU IVDR 2017/746. A CRO with genuine medtech experience will understand these nuances and help you avoid costly mistakes.
Why Do Sponsors Use CROs?
Access to expertise
Clinical investigations require a wide range of specialist skills that most device companies, particularly early-stage ones, do not have sitting permanently on their team. A CRO brings ready-made expertise across study start-up, clinical operations, data management and study document writing.
Speed
Setting up an internal clinical investigation infrastructure takes time. A CRO already has the systems, processes and networks in place to get your study moving faster. This can make a meaningful difference to your overall development timeline.
Cost efficiency
Hiring and maintaining a full in-house clinical team is expensive, particularly for a company running one or two studies. Outsourcing to a CRO means you access the expertise you need for the duration of the study without the long-term overhead.
Regulatory credibility
Regulators expect clinical investigations to be run to a high standard. Working with an experienced CRO demonstrates that you have the right expertise in place and can support the credibility of your submission.
Full Service vs Functional Support
One of the first decisions to make when considering a CRO is how much you want to outsource. The best model will depend on your internal capabilities, the complexity of your investigation and how much control you want to retain over the day-to-day running of the study.
Big CRO vs Small CRO
Size is one of the most practical considerations when choosing a CRO and it is worth thinking about carefully.
Large, global CROs typically offer significant resource and geographic reach. They can run complex, multi-country investigations and have established relationships with sites around the world. For very large studies, this infrastructure can be an advantage.
However, for most medical device companies, and particularly for small and mid-sized sponsors, a large CRO can come with its own challenges, such as higher overhead costs, competing projects, a more generalist approach and teams with less specialized expertise.
Smaller, specialist CROs often offer a more attentive and agile service. With a focused team and a narrower area of expertise, they tend to be more responsive, more flexible and better placed to give your study the attention it deserves (Read more about that here: Why Choosing a Small Contract Research Organisation (CRO) Is a Smart Move).
The right choice will depend on the scale and complexity of your study but for many device companies, a specialist smaller CRO may deliver better value and a smoother team integration and collaboration.
Overall
A CRO can be one of the most valuable partners a medical device company works with during clinical development. The right CRO brings expertise, capacity and credibility to your investigation and helps you navigate the regulatory requirements that sit between your device and market approval.
Whether you need end-to-end support or help with a specific part of your study, feel free to book a call and we can talk through what would work best for you. Contact Us.
