Qmed is an EU medical device CRO and consultancy, helping manufacturers plan, start, run, and close clinical investigations across Europe. We support pre-market and post-market work, and we work with both organisations that want a full-service partner and organisations that need a defined part of the work handled well.

We do cover work in other markets as well, such USA or Australia, in collaboration with thoroughly selected partners. 

What Clinical Affairs means at Qmed

For us, Clinical Affairs is not a narrow monitoring function. It is the operational engine behind clinical evidence generation.

That includes study planning, country and site strategy, start-up, ethics and authority interactions, project management, monitoring, vendor coordination, data handling, safety workflows, close-down, and reporting support. It also means understanding the regulatory purpose behind the work, so clinical execution does not become detached from the evidence and market-access goals it is meant to support.

Projects are led by experienced specialists. Clients should feel that the people shaping the work understand both the detail in front of them and the wider path still ahead.

How we support the study lifecycle

Set-up

We support the work that turns a study from intent into something operationally ready. That can include submission planning, country and site selection, contracts, Trial Master File (TMF) setup, database planning, vendor coordination, training, risk-based planning, and start-up activities.

Live phase

During study conduct, we support the day-to-day control that keeps a trial on track: study management, monitoring, site communication, issue handling, data workflows, query handling, safety processes, vendor oversight, and practical coordination across stakeholders.

Close-down

At the end of the study, we support the work that turns activity into a usable outcome: data cleaning and lock, analysis coordination, final reporting, archive readiness, inspection support, and the close-out activities needed to move into the next regulatory or commercial milestone.

Where we support

Our Clinical Affairs work spans:

• Clinical investigations for medical devices before market access
• Performance evaluation support for IVD-related work where relevant
• Post-market studies
• PMCF activities
• Registry- or survey-based evidence generation where appropriate
• Focused operational support where a client does not need a full-service CRO model

Flexible support, not one fixed model

Some clients want one partner to take ownership of the full clinical workstream. Others want to keep parts of the project in-house and use Qmed in a more fractional way. Both models can work.

What matters is that responsibilities are clear, interfaces are managed properly, and the clinical work supports the broader regulatory objective from the beginning. Where needed, we step in with a defined scope. Where it makes more sense, we take on the full operational package.

Typical situations

Usually, medtech innovators are experiencing one or more of the following:

• they have funding and a clear product direction, but the clinical workstream is not yet operational
• they need a European CRO that understands medical devices, not a generalist trial provider
• they have a protocol or evidence objective, but not the delivery structure behind it
• they need post-market evidence without building a large internal organization
• they want senior support close to the work, not a hand-off to junior delivery after the sale

How Clinical Affairs works with Regulatory Affairs

Clinical execution does not sit on one side of the business while regulatory work sits on the other. The strongest projects are built with both in view from day one.

At Qmed, Clinical Affairs works in step with Regulatory Affairs and Clinical Development. That means claims, evidence gaps, study design decisions, approvals, and post-market obligations are considered early, not handed over late. The point is not to make projects feel more complex. The point is to stop them becoming more complex later.

Talk to Qmed

Tell us about your next milestone, which countries are in scope, and what you’re looking for in a clinical partner. We’ll take it from there.