NorPedMed

The NorPedMed Coordinating Office is the national contact point for pediatric clinical trials in Norway. The office is physically located at the Pediatric Department at Haukeland University Hospital in Bergen.

We receive and process inquiries related to both industry-sponsored and investigator-initiated studies. We connect you with investigators and sites across our nationwide network, or with other relevant experts, including highly specialized pediatric expertise as well as regulatory and ethics expertise, thereby functioning as a one-stop-shop for study initiation in Norway.

External partners considering clinical trials in children are welcome to contact us.

A short email with basic study information is sufficient to get started.

We are generally available by phone or SMS.

We aim to respond to inquiries within the next working day, and no later than one week.

Direct contact

Thomas Halvorsen
Director and consultant pediatrician
📞 +47 924 64 843
✉️ thomas.halvorsen@helse-bergen.no

Sigrun M. Hjelle
Coordinator
📞 +47 971 97 520
✉️ sighje@helse-bergen.no

NorPedMed provides a single entry point to Norway’s paediatric clinical trial capacity across the country’s six university hospitals.

We coordinate rapid, realistic national pre-feasibility based on input from relevant clinicians and laboratories across the country.

We support site selection and study placement by aligning study requirements with patient pathways, referral practices, recruitment potential, and current site capacity.

NorPedMed’s dedicated paediatric Clinical Trial Units conduct studies locally within routine clinical care pathways, ensuring practical study delivery while maintaining patient safety.

Once a study is initiated, NorPedMed can provide follow-up and coordination across sites, helping address operational challenges and supporting momentum if recruitment slows.

Before study placement

Initial enquiry

Sponsors or CROs contact NorPedMed with enquiries related to paediatric clinical trials at any stage of planning or conduct, including questions about patient populations, clinical practice or study feasibility.

National pre-feasibility dialogue

Based on shareable information and strong insight into paediatric care in Norway, NorPedMed discusses the enquiry within the network and with relevant senior clinicians or laboratories before providing a coordinated reply on feasibility and patient availability.

Site selection strategy and study placement

Based on this dialogue, NorPedMed supports site selection and study placement by identifying paediatric Clinical Trial Units best suited for the study, drawing on national insight into patient pathways, referral patterns, recruitment potential and relevant clinical expertise.

Preparing study start-up

Regulatory, ethics and country-specific considerations

NorPedMed draws on practical experience with Norwegian regulatory and ethics requirements within the CTIS framework and can provide guidance on ethics committee expectations, consent requirements and data protection considerations.

Coordinated study start-up

Once sites are selected, NorPedMed can help coordinate communication between the sponsor and the participating sites, and take part in site start-up meetings upon request.

During study conduct

National follow-up and troubleshooting

The network regularly reviews ongoing studies across sites to identify challenges early and discuss practical solutions. If operational, regulatory or recruitment challenges arise during study conduct, NorPedMed can support sites through the local paediatric Clinical Trial Unit leads. These senior, clinically active paediatricians can engage directly with colleagues, investigators or hospital departments to resolve issues and keep studies moving, and support regulatory and ethics prosesses.

NorPedMed is a national collaboration of six paediatric Clinical Trial Units (pCTU) serving the paediatric departments at Norway’s six university hospitals, operating through a shared national structure.

Each pCTU is led by a senior, clinically active paediatrician with a strong position within their department and solid research credentials, with PhD-level as a minimum.

The units collaborate rather than compete and meet regularly in monthly network meetings. Together they ensure that studies are placed at the most appropriate sites and conducted successfully once initiated.

All participating pCTUs operate in accordance with Good Clinical Practice (GCP), and the network has experience with audits from sponsors and major regulatory authorities.

The network has broad and longstanding experience across all aspects of paediatric clinical trials, including sponsor audits, regulatory inspections and operational challenges. Sites draw on this collective experience when new challenges arise.

Norway’s publicly funded healthcare system provides universal access to specialist care, supporting broad and representative recruitment and population-based clinical trial data.

Despite its relatively small population, high public trust, a well-coordinated healthcare system and a digitally competent, financially secure population support efficient identification and recruitment of study participants, reliable long-term follow-up, and ethically robust clinical studies.

Well-established clinical care pathways and integrated hospital and outpatient services allow children to participate in studies closer to home while maintaining appropriate clinical oversight. The network has established and continues to develop experience in decentralised and hybrid trial models.

Norway is a highly digital society where both the healthcare system and the population are accustomed to digital interactions, supporting efficient trial conduct and digital or decentralised study elements where appropriate.

Unique lifelong personal identifiers and comprehensive national health registries enable reliable follow-up and high data completeness, supporting long-term safety and outcome analyses where relevant.

Under the EU Clinical Trials Regulation (CTR), submission and communication in CTIS remain the sponsor’s responsibility.

NorPedMed supports sponsors and CROs with practical, country-specific guidance on Norwegian regulatory and ethics expectations, including consent considerations and aspects with study design that may affect timelines.

Where sponsors find it useful, NorPedMed can facilitate early dialogue around regulatory and ethics considerations. Our experience shows that early dialogue through NorPedMed can help identify potential challenges and facilitate practical solutions during study set-up.

NorPedMed is not a separate legal entity.

Instead, NorPedMed is embedded within Norway’s university hospital system and forms part of the clinical and administrative structure where paediatric trials are conducted.

Clinical trial agreements and budgets are handled locally by each university hospital, supported by experienced legal, contracting and finance teams who routinely manage industry-sponsored clinical trials across both paediatric and adult specialties.

NorPedMed supports sponsors by coordinating expectations across sites, facilitating early alignment on budget assumptions and institutional requirements, and helping sponsors navigate country-specific aspects of contracting and data protection in Norway.

Established in 2013, NorPedMed has more than a decade’s experience supporting paediatric clinical research, enabling children to participate in well-designed industry-sponsored and investigator-initiated studies and as well as providing sponsors with a professional framework.

NorPedMed is embedded within Norway’s public healthcare system and supported by national health authorities through dedicated funding and national health policy priorities.

This national foundation integrates paediatric clinical trials into routine clinical care and supports consistent quality, regulatory compliance, and patient safety across the country.

Through close collaboration with clinically active investigators, NorPedMed supports a broad range of industry-sponsored paediatric trial designs across therapeutic areas.

NorPedMed contributes to the European paediatric research ecosystem through long-standing and active participation in collaborative initiatives and infrastructures, including NordicPedMed, ECRIN, PedCRIN, Enpr-EMA, conect4children (c4c), and its successor c4c-s.

This engagement ensures alignment with European standards and processes and enables sponsors to access Norwegian and Nordic paediatric trial capacity within a coordinated European research environment