Selecting a Clinical Research Organization (CRO) is a decision that requires careful consideration. The choice of partner can directly impact timelines, costs, and regulatory outcomes. To make the best decision, it is important to review not only the CRO’s service portfolio but also the clinical expertise of its team. This helps you assess if the CRO is truly capable of supporting the type of project you need. 

As a business development manager at Qserve’s CRO, I hear the same questions from sponsors almost every day: 

• - What is sufficient and valid clinical data for MDR/IVDR compliance? 
• - Is a PMCF survey enough, or do we need a full clinical study?
• - How long does it take to collect the necessary clinical data? 
• - Do we need to submit applications in each country, or is everything centralized through EUDAMED?
• - How many monitoring visits are required per site?
• - Is our current clinical strategy strong enough for the MDR/IVDR? 
• - What type of statistical justification do we need to prepare? 
• These questions became more common after the MDR came into force on 26 May 2021. The regulation introduced stricter requirements, and many companies still struggle to navigate them. It is easy to get stuck when trying to interpret the rules alone, and sometimes a second pair of eyes is all you need to gain clarity. 
• At Qserve, we offer this kind of support. Our clinical team combines hands-on trial experience with in-depth knowledge of MDR and IVDR requirements, helping clients design the right strategy and avoid costly missteps. To make this process more accessible, we always provide a free 30-minute consultation with one of our Senior Clinical Consultants. In this meeting, you can ask your key questions, get practical answers, and walk away with a clearer next step. For many companies, this is enough to solve the immediate issue, while for more complex projects it provides the direction needed to move forward. 

What to Consider When Selecting a CRO

When you evaluate potential CRO partners, here are some key areas to focus on in your first conversations: 

- Scope of Services: Does the CRO offer only clinical trial support, or can they also provide QA, RA, and CA expertise? A partner with a broader scope can give you holistic support across all regulatory touchpoints.

- Medical Device Focus: Is the CRO specialized in medical devices, or is it primarily pharma-focused? A 100% MedTech focus ensures deeper knowledge of device-specific regulatory requirements and Notified Body expectations.

- Customized Proposals: Does the CRO provide a tailored proposal based on your project needs, or a generic template? A customized approach ensures you only pay for the time and resources your project requires.

- Flexibility: Can the CRO manage a full-service project such as a clinical investigation, registry, or PMCF survey, but also step in for smaller tasks like protocol review or data strategy guidance? Flexibility means you get the level of support that fits your company best, with one central point of contact who understands your product. 

Get Expert Guidance, Risk-Free

Selecting the right CRO is about more than cost. It is about trust, expertise, and the ability to guide you through complex MDR and IVDR requirements. At Qserve, we pride ourselves on being a MedTech-focused partner with a broad service scope, tailored proposals, and a flexible approach. 

If you would like to discuss your project or get clarity on your next steps, we invite you to book a free 30-minute consultation with Celien van Lochem, Qserve CRO's Business Development Specialists, and one of our Senior Clinical Consultants. With no strings attached, it is an opportunity to get your questions answered and see how we can support you.