Service Partner for clinical activities
Our benchmark is the unique combination of our Qserve CRO team with field experience, regulatory intelligence and practical approach. The clinical consultants had former positions within CRO’s and medical device manufacturers dealing with a broad range of clinical data. Together with the Regulatory and Quality experience of the Qserve team, the clinical experts support manufacturers with top class clinical strategies based on the data available. Our experts know in detail the requirements of the Notified Body. Many of the Qserve employees had former positions at a Notified Body which provides detailed knowledge of the process, the requirements, and the practical issues of clinical reviews.
Qserve CRO serves as a partner for pre-CE clinical investigations, PMCF studies, registries, retrospective data collection and surveys.
Qserve CRO mission
Our mission is to help improve patient safety and health through supporting the advancement of (bio)medical technology. We assist medical device and in-vitro diagnostics manufacturers worldwide with clinical strategies, pre-CE clinical investigations, PMCF studies, registries, retrospective data collection and surveys, while achieving and maintaining regulatory compliance. We strive to do this with a practical approach balancing business needs, regulatory compliance, and budget. We are passionately working for our customers on clinical, regulatory, and quality challenges and see it as our responsibility to create a diverse global team of professionals who share the same passion for medical device technology, a high standard of quality, competence and customer service, and enjoy the fun of working on this together every day. Our people make our firm.
The Qserve Group
Qserve Group is founded in 1998 by Willibrord Driessen and started with a small group of regulatory experts. In 2014 three new shareholders joined the Board of Directors. Since 2017 the board of Qserve Group consists Jan van Lochem, Martin de Bruin and Gert Bos. Now 2020, Qserve is a global player, well known among medical device manufacturers, with offices in EU (UK, Germany, Belgium), US, China, and headquartered in The Netherlands.
Long before the introduction of the new shareholders, Qserve was active as CRO. A medical doctor, CRA’s and clinical managers where helping medical device manufacturers with clinical studies, mostly with implants in the cardiovascular, orthopedic and neurovascular field. With the introduction of the new EU regulation (MDR), Qserve board decided in 2016 to form a dedicated clinical team with the aim to support manufacturers with all l aspects of clinical data gathering, researching, and documentation. The team is ready now for the next step that manufacturers will encounter, the reviews and audits of Notified Body under the MDR.
“To serve our customers to the fullest, CRO activities do fit naturally in our portfolio, making maximum use of the broad knowledge and experience within our company. The changing regulatory environment request more clinical data collection to be fully regulatory compliant.
Our CRO services answer directly to this request.”
Jan van Lochem, CEO Qserve
Our partners
Our customers
April 2020
Qserve gives a clear overview
“The ISO 14155 GCP training provided by Qserve gives a clear overview of all the ins and outs of clinical trials with medical devices.
The trainers adjust the training to the public demand and provide enough space for questions and brainstorming sessions.”
April 2020
Really appreciated the enthusiasm
“Although the training was virtual, I have really appreciated the enthusiasm of the trainers, their experience in the field and the fruitful discussions.”
April 2020
Very clear concrete and effective
“The training gave me the full picture about what is needed to be compliant with the ISO 14155. As my first training on the topic, I found it very clear concrete and effective.”
22 January 2020
Hands on approach
“I work since the beginning of 2019 with Qserve and we are currently running multiple studies.
The CRO team have a hands on approach and deliver practical support, the fact they have good relations with the notified bodies make live much easier.”
18 December 2019
Strong partnership
“By combining our expertise in clinical data management with QServes regulatory experience, we’ve created a strong partnership that will help MedTech companies address the new clinical requirements brought on by the EU MDR.”
9 January 2020
We highly appreciated their method
“Qserve CRO enriched our project with their pragmatic and solution-oriented approach. We highly appreciated their method, coupled with agile execution. This enabled us to allocate our resources optimally.”
18 December 2019
Good refreshment
“I found the ISO 14155 training course a very good course. For me it was a good refreshment but for people with no or only basic knowledge of ISO 14155 the course is also very suitable. The interactive elements and the test at the end are a nice variety from the theoretical part. The course exceeded my expectations.”
25 November 2019
Good advises
“The training provided me another options of interpretation of the new MDR; good advises; strengthened me in what I do.”
Our team
Loes Pelgrim
Sr. Clinical Project Manager
Sr. Business Developer
Wiebe Postma, PhD
CRO Lead
Nadira Salah, PhD
Clinical Research Associate
Celien van Lochem
Business Development Specialist CRO
Leonard Buchner
Sr. Statistician
Daan Pelgrom
Business Development Manager Europe
Ra’na Saleem
Sr. Data Manager
Jan van Lochem
CEO
Abigail Jaitman
Clinical Project Manager
Rachel Derksen
Clinical Project Manager
Vacancy: Clinical Project Manager
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Vacancy: Clinical Writer – Medical Devices
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