Qserve CRO: Your Trusted Clinical Service Partner

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 CROs and medical device/IVD 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 and Qserve CRO 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.

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.

CRO team

Our dedicated core team

Bianca Lutters

Bianca Lutters

Head of Clinical Operations

Celien van Lochem

Celien van Lochem

Business Development Specialist CRO

Gert W. Bos, PhD, Fraps

Executive Director & Partner

Wouter Mattheussens

Wouter Mattheussens

Project Manager

Laura Castro

Laura Castro

Clinical Project Manager

Martin de Bruin, MSc

Executive Director & Partner

Ceasar Roseboom

Caesar Roseboom

Clinical Project Manager

Amber Majoor

Amber Majoor

PMCF Writer

Nienke Flipsen

Nienke Flipsen, Msc

Data Manager

Armel Plaine

Armêl Plaine, PhD

Principal Clinical Project Manager

Esther Sánchez

Esther Sánchez

Medical Writer

Maria Camara Torres

Maria Camara Torres

Medical Writer

Dulce M. Aguilar-Garza

Dulce Aguilar

Medical Writer

Patricia da Sila Peres

Patrícia da Silva Perez

Medical Writer

Jelena Kresoja

Jelena Kresoja

Medical Writer

Jorn van Binsbergen

Jorn van Binsbergen

Clinical Writer

Jasmin

Jasmin Hunter

Senior Consultant

Claire Borde

Claire Borde

Clinical Writer

Iris Verboven Qserve CRO

Iris Verboven

Team Manager

Jan van Lochem CRO Qserve

Jan van Lochem

CEO

Henk-Willem Mutsaers, MSc

Data Protection Officer

Elevating Experiences: Satisfied Clients

Strong Partnership

“By combining our expertise in clinical data management with Qserve’s regulatory experience, we’ve created a strong partnership that will help MedTech companies address the new clinical requirements brought on by the EU MDR.”

Jon I. Bergsteinsson / SMART-TRIAL | Made for Medical Devices

Empowering Training and Expert Insights

“The training opened up new avenues for interpretin…spectives. The guidance and advice provided were instrumental in bolstering my confidence and competence in my role.”

Attendee PMS/PMCF Training 

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.”

Dr. Ela Bingel-Erlenmeyer / Group Lead Clinical Trials & Deputy Director Geistlich Pharma

Achieving CE Mark Success

“It gives me great pleasure to inform you that our Notified Body will be recommending our device for the CE mark. I can’t thank Qserve enough for getting us through the final Clinical Evaluation hurdle with them.”

– Satisfied Client

Partners who support us

Quinten
QServe CRO_Smart-Trial

Customers who trust us

QServe CRO_Philips
QServe CRO_Ambu
QServe CRO_Geistlich
QServe CRO_Cingular Biotech
QServe CRO_Gelita Medical
QServe CRO_IQ Medical Ventures
QServe CRO_Inreda

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 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.

Qserve Group

Qserve Group was founded in 1998 by Willibrord Driessen and started as a small group of regulatory experts. In 2014, three new shareholders joined the Board of Directors. Since 2017, the board of Qserve Group consists of Jan van Lochem, Martin de Bruin, and Gert Bos. Now 2023, Qserve is a global player, well-known among medical device manufacturers, with offices in the EU (UK, Germany, Belgium, Italy), US, China, and headquartered in The Netherlands.

Long before the introduction of the new shareholders, Qserve was already active as CRO. With the introduction of the new EU regulation (MDR), the Qserve board decided in 2016 to form a dedicated clinical team with the aim of supporting manufacturers with all aspects of clinical data gathering and activities under ISO14155 GCP.

Jan van Lochem CRO Qserve

“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

“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

Jan van Lochem CRO Qserve