Collaborate with us

The Clinical Trial Unit for Paediatrics and Adolescent Medicine is a specialised research unit at Rigshospitalet, serving as a study site for clinical research involving children and adolescents. Our activities include both sponsor-initiated and investig​ator-initiated studies, including clinical drug trials, registry studies, and medical device studies. We work closely with our partners throughout the entire study lifecycle and support both national and international clinical research projects.

We manage all key study activities, including:

• Feasibility assessments
• Study start-up and site initiation
• Patient identification and recruitment
• Planning and conduct of study visits​
  
• Delivery of study-related treatments and procedures, including medication administration and parent training in medication administration where relevant
• Handling, processing, and storage of biological samples in our research laboratory
• Data collection and study documentation
• Monitoring visits, sponsor visits, and regulatory inspections
• Coordination with relevant clinical departments and support functions

• Study close-out and archiving

Read more about our research here

Experience and expertise

The Clinical Trial Unit for Paediatrics and Adolescent Medicine has extensive experience in the planning, start-up, and conduct of clinical drug trials involving children and adolescents. Our multidisciplinary team consists of Principal Investigators, Sub-Investigators, Clinical Research Coordinators, Research Staff, and Management personnel with specialised expertise in both clinical research and paediatric disease areas. Together, they ensure that clinical trials are conducted in accordance with the highest scientific, ethical, ​and regulatory standards, including ICH-GCP E6(R3), ALCOA++, and the requirements of the Danish Medical Research Ethics Committees and the Danish Medicines Agency.

We have established procedures for the management and maintenance of GCP documentation for all study personnel, including CVs, GCP certificates, and delegation logs. Documentation is collected, verified, and regularly updated to ensure compliance with current regulatory requirements and sponsor expectations. The unit operates according to a comprehensive set of Standard Operating Procedures (SOPs), which support quality assurance and ensure consistent processes across all study activities.

In addition, we have well-established procedures for study start-up, study conduct, documentation, and quality control. Our clinical research coordinators play a key role in ensuring that studies are conducted in accordance with the study protocol, applicable legislation, and quality requirements.

Facilities and infrastructure

As part of Rigshospitalet, we have access to highly specialised clinical and diagnostic services, as well as expertise across a wide range of medical specialties. This enables us to conduct both national and international multicentre studies across a broad spectrum of paediatric disease areas.

Our unit offers dedicated facilities for clinical research, including consultation and examination rooms for study visits, sample collection and infusion, monitoring facilities, storage of biological samples, and secure handling and archiving of study documentation.

​Collaborators and clinical partners

We collaborate with both national and international research partners. Below are some of the departments and functions at Rigshospitalet with which we work closely in the conduct of our studies.

Juliane Marie Centre

• Department of Paediatrics and Adolescent Medicine, including all subspecialties
• Department of Growth and Reproduction
• Department of Clinical Genetics​
  

The Neuroscience Centre

• Department of Neuroanaesthesiology
• Department of Neurology​

Centre of Head and Orthop​​aedics​

• ​Department of Occupational Therapy ​and Physiot​herapy​
  

The ​​Heart Centre

• Department of Cardiology
  

Clinical Immunology

• Histocompatibility Lab​oratory
  

Centre of Diagnostic Investigation

• Department of Diagnostic Radiology​
  

Other Collaborators

• Clinical Trial Unit for Children and Adolescents with Cancer
• Capital Region of Denmark Pharmacy​
  
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