At Qserve CRO, we take pride in our team of highly skilled professionals who are committed to delivering high-quality clinical trial services. Today, we are delighted to introduce you to Nienke, an experienced Clinical Data Manager whose expertise ensures the integrity and efficiency of clinical data.

A Versatile Background in Medical Device Startups

Nienke joined Qserve almost two years ago, bringing with her valuable experience from various medical device startups. Working in such dynamic environments required her to manage tight budgets, wear multiple hats, and make quick, informed decisions. This adaptability has shaped her practical and solution-oriented approach, making her an asset to our CRO team.

Nienke thrives on finding solutions rather than focusing on limitations. She embraces challenges with a mindset that prioritizes possibilities and options, always seeking the most effective and efficient way forward. Thanks to her hands-on approach, she has played a key role in optimizing our CRO Quality Management System (QMS) and successfully implementing our eTMF and CTMS. Additionally, she is a certified designer for most of the leading Electronic Data Capture (EDC) systems in the market.

A Key Player in Clinical Data Management

Based in the Netherlands, Nienke works closely with our biostatisticians to ensure that clients receive valuable clinical data for submission reports to Notified Bodies and the FDA. Her expertise spans data management plans, electronic Case Report Forms (eCRF), data verification plans, data cleaning, and statistical analyses. She is known for her straightforward, pragmatic communication style, ensuring that all processes remain simple, workable, and fully compliant.

Beyond her data management expertise, Nienke also performs (expert) audits for ISO 14155. Her in-depth knowledge of ISO 14155 and MDR 2017/745, along with her experience in designing and conducting animal trials, further strengthens Qserve CRO’s capabilities in regulatory compliance and clinical research.

Partner with Qserve CRO for Reliable Clinical Data Management

If you are looking for a reliable partner to manage your clinical data efficiently and compliantly, Nienke and the Qserve CRO team are here to help. Whether you need comprehensive data management support or assistance with specific aspects of your trial, we are ready to ensure the success of your study.

Contact us today to learn more about our expertise and how we can support your clinical trial needs.