A clinical investigation is where the evidence strategy stops being theoretical. Once a device needs prospective clinical data, the work becomes more demanding very quickly: approvals, sites, contracts, monitoring, data handling, safety workflows, timelines, and day-to-day control all need to hold together.
Qmed supports medical device and IVD manufacturers through that process across Europe. We act as an EU medical device CRO and consultancy, with the ability to take on full-service study delivery or a defined part of the investigation where that is the better fit.
What this service covers
This service covers pre-market clinical investigations designed to generate the data needed to support safety, performance, and clinical claims before market access or major regulatory milestones.
Typical support can include study planning, protocol and document input, country and site strategy, submission support to ethics committees and competent authorities, Trial Master File (TMF) setup, database planning, monitoring, vendor coordination, data and safety management, close-out, and reporting support.
How Qmed supports the investigation lifecycle
Set-up. We help turn a study objective into something operationally ready. That can include the submission path, site and country feasibility, contracts, risk-based planning, study documentation, training, vendor set-up, TMF structure, and database planning.
Study conduct. We support the control mechanisms that keep the investigation moving: project management, site communication, monitoring, issue handling, data workflows, query management, safety processes, and coordination across stakeholders.
Close-out. We support data cleaning and lock, analysis coordination, final reporting, archive readiness, inspection support, and the close-out work needed to move into the next regulatory step.
Typical situations
Typically, medtech innovators come to us with one or more of the following challenges:
- they have funding and a clear product direction, but the clinical investigation is not yet operational
- the evidence objective is understood, but the execution model is still weak or fragmented
- they need an EU partner that understands medical devices rather than a generalist trial model
- they want one team to manage the interfaces between approvals, sites, data, monitoring, and reporting
- they need senior delivery close to the work, not a hand-off after an agreement is made
Talk to Qmed
Tell us what device you’re investigating, which stage the study is at, and where you need support to move it forward.