Outsourcing Clinical Activities in 2024: Choosing A CRO

In Greenlight Guru’s 2024 State of the MedTech Industry Report, 70% of respondents told us they were going to outsource at least some of their clinical activities to a contract research organization (CRO) or consultant this year. 

That number makes sense, as planning, conducting, and analyzing clinical activities can be an enormous amount of work. Many MedTech companies find it much simpler to get outside expertise to help them get the clinical data they need. That could mean a consultant helping with a single aspect of clinical operations, a full service CRO, or anything in between. 

Regardless, if you’re one of the many MedTech companies considering outsourcing some (or all) of your clinical activities, this article will help guide you through the process.

BONUS RESOURCE: Click here to download a free cheat sheet, with 7 key considerations, to help you choose a Contract Research Organization (CRO).

What services do CROs provide?

A CRO is an organization that another company (the sponsor) engages with to take the lead in managing that company’s trials and complex medical testing responsibilities. Nearly three quarters of medical device clinical trials are conducted by CROs on behalf of a sponsor, making them a very common choice for clinical operations.

However, there’s often a misconception that CROs are just for conducting pre-market clinical studies. The reality is there’s a need for clinical activities and resources at every stage of the device lifecycle. As the image below shows, pre-market clinical studies are far from the only clinical activities that MedTech companies will need to carry out.

That means there’s a wide range of services that a CRO can provide your MedTech company, including:

• Pre-clinical services
• Feasibility assessments
• Participant recruitment
• Project management
• Regulatory dossier and ethics submissions
• Phase I, phase II-III, and phase IV clinical trial management
• Site selection
• Trial monitoring
• Data Management
• Pharmacovigilance
• Statistical analysis
• Medical writing
  

A full-service CRO may offer you all of these services, while other CROs may specialize in specific areas. Whether you choose to use all of the services offered, or decide to perform some of these in-house is dependent on your specific circumstances.

How to determine what you’ll need from a CRO

It’s a good idea to look internally and at least get a general sense of which clinical activities you’ll need help with before approaching a CRO. That’s not to say you have to know exactly what you’ll need help with, but it’s worth figuring out a general breakdown of what you’re capable of doing in-house and what you’d like to outsource. 

Here are a few steps you can take to help determine what you’ll need from a CRO:

1. Define your requirements (consider the SMART approach). In other words, your requirements should be Specific, Measurable, Attainable, Relevant, and Time-bound. This will help ensure that when you present your needs to a specific partner, they’ll quote you for what you need and nothing more or less.
2. Map which requirements can be handled in-house. Many internal clinical teams are fairly lean, and you’ll need to take a hard look at internal resources available to you. Consider whether you want to bring on more staff internally, or if you’d rather outsource more of the work.
3. Document results and refer back to your initial requirements. Once the process is underway, it’s important to track progress and continually assess whether your initial requirements are being met. Understanding your partner’s performance will help you course correct, if necessary, and help you decide whether this partner is the best fit for future clinical activities.

What clinical activities should you stay involved in when outsourcing?

Keep in mind, working with a third-party doesn’t necessarily mean handing over your entire clinical operations and then forgetting about it. There are some areas where even if you’re working with a CRO or consultant, it’s still a good idea to stay involved in the process. 

The following breakdown is based on our experience at Greenlight Guru, and is a subjective list that might not apply to every situation. However, this is a pretty common split we tend to see between what companies will want to hand off entirely and what they should stay involved with.

Traditional outsourcing activities with less sponsor involvement:

• Writing the clinical protocol

• Contracting (e.g. with sites/investigators)

• Monitoring

• Overall project management

Activities where sponsor involvement pays dividends:

• Defining primary and secondary endpoints of clinical studies
• Defining key elements in informed consent and data processing consent
• Defending the ethics application for your device (i.e. why should your study be approved)
• Patient recruitment and biostatistics

You’ll notice that the items I’ve listed in the second section are heavily related to the device itself. Your CRO is an expert in clinical operations, but you know your device best. When it comes to defending it to an IRB or defining the endpoints for your studies, your knowledge and perspective on the device is irreplaceable.

BONUS RESOURCE: Click here to download a free cheat sheet, with 7 key considerations, to help you choose a Contract Research Organization (CRO).

What to bring when meeting with a CRO?

The more information about your proposed study, your device, and your patient population that you can bring to the table during your meeting with a CRO, the better. Below, I’ve listed the ideal documentation you should bring (or send ahead of time, really), but it’s okay if you don’t have all of this prepared beforehand:

• Proposed timeline of the study
• Description of the device plus its indications for use
• Description of the study / synopsis of the proposed protocol
• Patient information inclusion and exclusion criteria
• All documentation for the proposed study including the protocol
• Scope of work being done in-house vs. what’s being outsourced

At the very least, you want to come to the table with your proposed timeline and the description of the device. The more of these bullets you can bring to the table, the better, but the first two points are the bare minimum. 

One tip here: Try to give as much of this information as possible to the CRO ahead of time. This will help them better understand your needs and it should help them prepare for the meeting. If you realize that the team hasn’t reviewed what you’ve sent before the meeting, that could be a sign this isn’t the right CRO for you.

Looking for a CRO? The Greenlight Guru Partner Network Can Help

At Greenlight Guru, we help support clinical teams not only with our award-winning electronic data capture (EDC) software, Greenlight Guru Clinical, but also by helping our customers find the services we don’t provide. 

As part of the Greenlight Guru Partner Program, we’ve been partnering with some of the top CROs to help bring their services to our customers. If you’re looking to outsource your clinical operations, our partner directory is an excellent place to start. You’ll be able to filter and search for CROs (and other partners) based on device class, device type, product lifecycle stage, or even by specific services. 

And if you’re ready to experience the leading clinical data collection toolbox—built specifically for MedTech, then get your free demo of our software today→.