Kirsten Clinical Research

Kirsten Clinical Research is a trusted partner for the coordination and management of clinical trials. Accredited by the French Ministry of Higher Education and Research under the Research Tax Credit (CIR), the company has been supporting sponsors and study partners since 2011.

Based near Geneva and backed by more than 20 years of operational experience, your studies are conducted with rigor, close collaboration, and strong commitment across a wide range of therapeutic areas, with a strong expertise in rare diseases.

We provide independent, tailor-made consultancy built on trust, clarity, and seamless collaboration. Kirsten Imbert works hand in hand with sponsors and study partners, adapting the support to each project’s needs while ensuring strict respect for timelines, budgets, and current quality standards. My approach is rooted in proximity, adaptability, and operational excellence.

 

Your projects will be a success thanks to our:

  • Strong commitment to advancing medical research
  • Energy and momentum, driven by hands‑on involvement and rigorous work
  • Solutions‑oriented approach, turning complexity into clear, actionable steps
  • Strong ability to connect people and bring teams into alignment
  • Clear and responsive communication
  • Solid professionalism, ensuring quality and integrity, including in “rescue” situations

 

Expertise

Founded and led by Kirsten Imbert – van Harmelen, who brings more than 20 years of experience in research and clinical study operations across the world, the company offers expertise in clinical trial coordination, project management, monitoring, quality assurance, and recruitment and retention strategies.

Operational and Therapeutic Expertise

  • Phase I-IV, drug, nutrition research, and medical device trials.
  • Metabolic diseases,
  • Endocrinology,
  • Hepatology,
  • Pneumology,
  • Inflammatory diseases,
  • Orthopedics, Neurosurgery,
  • Haematology
  • Cardiovascular.
Over the past decade, I have developed particular strength in rare diseases and pediatric studies, where adaptive approaches, close site collaboration, and tailored recruitment strategies are essential to study success.

 

Scientific Background - Kirsten Imbert

I graduated from Wageningen University in the Netherlands with a Master’s degree in Nutrition and Health Sciences, specializing in both Nutrigenomics and Toxicology. This strong scientific foundation supports my rigorous, analytical approach to clinical research. Over the past 20 years, I have contributed to the successful development of multiple drugs, medical devices and medical food products, supporting studies conducted across Europe and the United States, and have been instrumental in the development of several products that are now on the market.

Approach

I am often called upon to step into complex or stalled projects, re-establish collaboration among stakeholders, clarify priorities, and restore progress, particularly in participant recruitment and site engagement, with clarity and momentum. My approach is people-centered and solution-oriented. I connect stakeholders, build trust quickly, and turn complex situations into clear priorities and actionable next steps. When timelines stall or communication breaks down, I step in to restore collaboration and move studies forward with structure, transparency, and efficiency.

 

Services

With a people-centered and solution-oriented approach, our mission is to deliver tailored support that adapts to your clinical needs at every stage of a study. All projects are conducted with strict respect for confidentiality, international Good Clinical Practice (ICH-GCP), and the highest ethical standards.

Studies can be conducted in French, English, German, and Dutch. Based near Geneva, we are ideally positioned to support European sites quickly and efficiently, ensuring responsive, hands-on collaboration across the continent.

CLINICAL TRIAL COORDINATION

KIRSTEN CLINICAL RESEARCH coordinates all study partners involved in a clinical study while maintaining a strong focus on client satisfaction, operational excellence, and close collaboration.

Relations and engagement, timelines, budget and quality form the foundation of our approach, ensuring rigorous and reliable study management.

Our coordination services include:

  • A highly experienced project manager as your primary point of contact
  • Study Feasibility, assessment of country and site suitability
  • Design and writing of study and participant facing documentation
  • Preparation of contracts, cost negotiation, and global budget oversight
  • Submissions of regulatory and ethics applications
  • Training of sites and investigators meetings
  • Recruitment management and performance tracking within agreed timelines
  • Development and implementation of a study-specific quality plan, including audits and co-monitoring
  • Coordination of all study partners (local CROs, logistics providers, central labs, data management, statisticians)
  • Central communication point ensuring regular, transparent reporting to the client, reinforced by operational proximity, adaptability, and a strong collaborative partnership.

 

RECRUITMENT AND RETENTION

Recruitment and retention are critical to the success of any clinical study, particularly in Phase 2 and Phase 3 trials, where timelines, patient availability, and protocol complexity can significantly impact outcomes. With extensive experience as Recruitment and Retention Manager in multiple large trials across the World, we coordinate sponsors and investigator sites in achieving realistic enrolment targets and maintaining strong participant and site engagement throughout the study.

Our recruitment and retention services include:

  • Strong engagement with investigators and sites, and patient advocacy groups to stimulate and maintain enrolment
  • Feasibility assessment of recruitment potential across selected countries and sites
  • Development of creative, tailored recruitment plans, strategies and solutions to strengthen recruitment and retention
  • Creation of educational materials for participants, study websites, site‑ and patient‑facing materials to support engagement and study understanding.
  • Continuous tracking of recruitment metrics and proactive issue resolution
  • Identification of recruitment barriers to participation and work hand in hand with sites to find solution and improve recruitment.

 

MONITORING AND QUALITY ASSURANCE

KIRSTEN CLINICAL RESEARCH delivers high-quality monitoring services for Phase I–IV clinical trials. With more than 20 years of experience in clinical operations, the company brings strong expertise and a practical, hands-on approach focused on meeting quality standards in an efficient and operationally sound manner. Together with the sponsor teams, we provide sites with the operational support they need, and we foster confidence, efficiency, and a strong sense of partnership.

A tailored monitoring approach, adapted to your needs

  • Serving as the central point of contact for investigators and the sponsor, from qualification to close‑out
  • Supporting recruitment and maintaining strong site engagement
  • Verifying source data and CRFs to ensure accuracy and consistency
  • Overseeing data collection and resolving queries within appropriate timelines
  • Ensuring full compliance with the protocol and ICH‑GCP
  • Applying strong project and data management skills to harmonize quality across sites
  • Restoring alignment and momentum when challenges arise
We provide a range of quality assurance services to ensure compliance, robustness, and inspection readiness:
  • Audits of investigator sites, study partners and vendors
  • Co-monitoring visits and training and supervision of Clinical Research Associates and CRO teams

 

CONTACT US

Let’s Advance Your Clinical Research Together

Whether you need full study coordination, targeted recruitment support, site engagement, or high-quality monitoring, together we can move your project forward with trust, efficiency, and partnership.

Contact us to discuss your study needs.