To help you select a partner who fits your study and your way of working, here are eight practical questions worth asking early in the process.
1. What experience do you have with my type of device or therapeutic area?
Every device has its own technological challenges, risk profile, intended purpose, and user group. Your partner’s hands-on experience with similar devices is one of the strongest predictors of smooth execution. Ask:
- Have you conducted studies for this type of device or indication?
- What challenges did you encounter in previous projects with similar technologies?
- A partner with relevant device experience can anticipate issues early and provide practical, targeted advice.
2. What regulatory pathway experience do you have?
Your regulatory strategy shapes your clinical strategy. Whether you’re targeting the EU, US, UK, or global markets, your partner should fully understand the requirements that apply to your chosen route. It’s a huge benefit if your partner not only has CRO experience, but also regulatory experience or services. Ask:
- Are you familiar with MDR/IVDR expectations for this type of submission?
- Do you have experience preparing studies for FDA (IDE, PMA, 510(k) with clinical data)?
- How do you ensure alignment between study design and regulatory expectations?
A partner with regulatory-pathway experience can help you avoid amendments, delays, and unnecessary back-and-forth with regulators.
3. Is your focus primarily Medical Devices, IVDs, Pharmaceuticals or all?
Not every CRO or consultancy specializes in MedTech. Some are more pharma-driven, others IVD-focused. Ask:
- What percentage of your work is in MD vs. IVD vs. pharma?
- Does your team include specialists with deep MedTech regulatory and clinical knowledge?
A clear focus ensures that your partner’s mindset, processes, and best practices truly fit your project.
4. How do you ensure compliance with MDR/IVDR and applicable ISO standards?
Compliance must be more than theoretical, it must be embedded in daily operations. Ask:
- Do you work fully in line with ISO 14155?
- How is MDR/IVDR expertise built into your QMS and SOPs?
- How do you ensure data integrity, documentation control, and audit readiness?
Strong compliance reduces both regulatory and operational risk.
5. Do you have established relationships with Notified Bodies and local regulatory experts?
This is often overlooked but extremely valuable. Ask:
- Have you supported clients through Notified Body clinical evidence reviews?
- Do you have in-house or collaborate with country-specific experts for submissions to Competent Authorities and Ethics Committees?
- Are you familiar with local nuances (e.g., Germany’s BfArM, France’s ANSM, the Netherlands’ CCMO/METC, US IRBs)?
Partners with these connections can navigate local requirements smoothly and prevent unnecessary delays.
6. How flexible can you be with study design and execution?
MedTech studies often require adaptable approaches, small sample sizes, or hybrid setups. Look for examples of:
- Risk-based, tailored monitoring;
- Hands-on approach where you’re also in charge of what’s happening;
- Scalable operational models;
- Pragmatic problem-solving when issues arise.
A flexible partner can avoid delays and keep momentum without compromising quality.
7. What does the collaboration look like from first meeting to study completion?
Smooth execution depends heavily on how teams work together. Ask:
- Who will be my dedicated point of contact?
- How do you communicate progress and escalate issues?
- How do you manage handovers and milestones?
A transparent, predictable working style builds trust and prevents misalignment.
8. What systems and digital infrastructure do you use to support the study?
Modern clinical operations rely heavily on robust systems to ensure data integrity, transparency, and audit readiness. Your partner’s digital infrastructure can significantly impact the efficiency and quality of your study. Ask:
- Do you have an eTMF in place, and is it compliant with industry standards?
- Which CTMS, EDC, or safety systems do you use?
- How do you ensure system validation and data security?
- Can sponsors access study data or documents in real-time?
A partner with well-established systems provides smoother collaboration, better oversight, and stronger inspection readiness.
Final thoughts
Choosing a clinical partner is about much more than comparing service lists or budgets. It’s about selecting a team you trust to guide your study through a complex, regulated environment while staying practical, transparent, and responsive.
By asking these eight questions, you gain a realistic picture of how a partner actually works, not just how they present themselves. And ultimately, that’s what determines whether the collaboration leads to smooth execution, strong evidence, and a confident submission.