Choosing a partner for your clinical research projects is a big decision. If you are considering working with Qserve CRO, you probably already know who we are and what we do. To help you picture the collaboration, we’ve gathered the most common questions we receive from sponsors and provided clear answers.
We begin with a structured kick-off where your project team and ours align on the details of what is needed, such as protocol definitions, endpoint ideas, timelines, deliverables, and communication preferences. This ensures clarity from the start and sets expectations on both sides. You’ll have direct access to the core team members managing your study, not just a project manager in the middle.
You will have a dedicated project manager as your central contact, but you’ll also know the lead clinical writer, regulatory expert, or statistician working on your project. Claire Borde, Wouter Mattheussens, and Daphne Smit-van den Hof are Qserve CRO's experienced project managers. We believe in efficiency, short communication lines, a practical approach, and transparency, so you always know who is handling your deliverables.
We combine the flexibility of a specialized CRO with the regulatory depth of Qserve’s global consulting team. This means you get a partner who understands not only how to run a study but also how to make sure the data stands up to MDR and IVDR requirements.
Yes. Some clients want us to fully integrate with their systems and tools, others prefer us to work independently and use our EDC and other suppliers of choice. The main goal for both approaches is to get the best results. We try to adapt to your way of working to respect your expectations while still ensuring compliance with regulatory requirements.
We cover the full range, from small post market clinical follow-up (PMCF) surveys to larger clinical investigations for all therapeutic area's MDR and IVDR. We also provide specialized services like clinical evaluation reports, literature searches, and data (statistical) analysis.
All work is carried out under our ISO 14155 and ISO 9001 aligned quality system. We document decisions and processes so you have a clear audit trail. Regulatory compliance is at the heart of every deliverable we provide. All of our team members do hold a recent ISO 14155 and GCP certificate.
Flexibility is one of our key strengths. We work with you to reassess scope, timelines, and resources, so your project continues smoothly. We make sure that compliance is covered and that timelines are respected.
Simply reach out to us with your project outline. We will discuss your goals, assess the best approach, and provide a tailored proposal with a clear budget and timeline.
Working with Qserve CRO means more than outsourcing a project. You gain a partner who understands the regulatory challenges of MedTech and brings clinical, regulatory, and quality expertise into one team.
Ready to discuss your pre-market study or PMCF needs? Feel free to contact us today.