NorPedMed1

NorPedMed is Norway’s national infrastructure for pediatric clinical trials. Established in 2013, NorPedMed facilitates Norway’s participation in international efforts to give children access to safe, effective, and innovative treatments. NorPedMed strengthens national capacity, ensures that pediatric trial activities align with global standards, and serves as a reliable single point of entry for international sponsors.

NorPedMed reflects Norway's strong commitment to improving the global evidence base for pediatric medicine, ensuring that children receive the same standard of research-based care as we expect to find in the adult world.

Children have historically been underrepresented in medical research. NorPedMed addresses this challenge by coordinating Norway’s national infrastructure for pediatric clinical trials and ensuring alignment with international ethical, scientific, and regulatory standards.

NorPedMed is a full member of the European pediatric research ecosystem through its role in EU initiatives such as NordicPedMed, conect4children (c4c), and Enpr-EMA. As such, NorPedMed offers a reliable single point of entry for international sponsors looking to engage with Norwegian and Nordic trial capacity within a harmonized European framework.

NorPedMed is a national collaboration of six pediatric clinical research units based at Norway’s six university hospitals, covering the entire Norwegian population. Operating under one coordinated structure, the network offers sponsors a single point of contact, rapid study start-up, and flexible site selection, ensuring efficient and harmonized conduct of pediatric clinical trials across the country.

NorPedMed is the umbrella organization for the six pediatric clinical trial units (Norwegian: KliniskForskningspost for Barn) located at Norway’s six university hospitals. Together, these units form a coordinated nationwide network with ready-to-activate capacity across the country.

A central coordination office ensures consistent procedures across all sites and serves as a single point of contact for sponsors. If challenged with tight timelines, a national pre-feasibility can be completed within days.

Each site is led by a senior pediatrician with strong links to both the pediatric department and other hospital units involved in children's care. They all have broad clinical experience, and solid scientific credentials. The six unit leads meet monthly online and collaborate closely, based on mutual trust, shared values, and national priorities - not competition.

NorPedMed holds monthly digital meetings, and annual in-person gatherings that also include all study-nurses. Long-standing professional ties ensure up-to-date alignment across the network.

The six units collaborate instead of competing, allowing studies to be allocated to the sites best positioned for success, based on patient availability, relevant experience, and current capacity.

For sponsors, this means:

- Access to the full Norwegian population (~5.5 million people) through one unified single point of contact - instead of six separate sites

- National coordination and shared expertise, paired with local insight and hands-on study execution

- Realistic national pre-feasibility assessments, fast study start-up, and harmonized procedures

- Built-in flexibility to place each trial at the site (or sites) best suited in terms of patient population, available capacity, and relevant expertise

Norway offers a unique setting for pediatric clinical research, with free and universal healthcare for all children, a digitally literate population, and a strong tradition of research participation built on trust and high ethical standards.Through NorPedMed, sponsors gain access to a nationally coordinated network with broad coverage and high-quality, decentralized study execution.

Norway combines a strong public healthcare system with a digitally competent and research-friendly population. With NorPedMed as a national platform, sponsors gain access to a well-integrated pediatric research network that spans the entire country.

Key advantages:

- Ethically sound recruitment: Families participate without financial incentives, reducing the risk of undue influence

- Universal, free access to public healthcare for all children: Funded by taxpayers money, this enables unbiased, population-based trial data

- Digitally literate population: Norwegian families are familiar with online tools, electronic case report forms (eCRFs), eConsent, and shared decision-making

- Decentralized access: Thanks to a well-integrated hospital system and advanced home care services, children can participate close to home – regardless of geography or diagnosis

- Sponsors benefit from working in a transparent, predictable, and ethically robust environment with national coverage and access to all pediatric subspecialties

NorPedMed offers industry sponsors a single point of contact for pediatric clinical trials in Norway - providing national knowledge and coordination, deep institutional insight, and practical support across all trial phases. From feasibility to ethics and recruitment, sponsors benefit from a trusted, transparent, and family-centered platform built for efficient and high-quality pediatric research.

NorPedMed provides a coordinated platform, designed to support industry and academic sponsors throughout all stages of pediatric clinical trials.

NorPedMed offers:

- System-wide insight: NorPedMed knows who does what, where, and how well - based on solid knowledge of Norway’s healthcare landscape, including local practices, care structures, and institutional roles.

- Coordinated national pre-feasibility: Delivered within days to a couple of weeks at the most, based on realistic assessments informed by solid knowledge of Norway’s pediatric healthcare landscape

- Access to experienced pediatric investigators: Senior pediatricians at each site with deep institutional insight and a clear understanding of how pediatric care is delivered, structured, and distributed across institutions

- Flexible and responsive study setup: If needed, capacity can be reallocated across sites to match study needs, thanks to the close and collaborative working relationship between the six pediatric clinical trial units

- Rapid resolution of challenges: Monthly coordination meetings and ongoing communication ‘as needed’ allow early intervention if problems arise. NorPedMed has successfully resolved delays and bottlenecks in past studies, including ethical issues

- Trusted clinical leadership: Senior pediatricians leading the trial units can play a key role in overcoming local recruitment challenges and obstacles, thanks to their clinical authority and on-site presence, thus complementing the work of sponsor-appointed coordinators

- Operational transparency: A complete overview of capacity and care structures across Norway ensures targeted, effective trial rollout

- Family-centered approach: NorPedMed supports sponsors in developing study setups that are feasible and acceptable for families, using digital tools, minimizing burden, and collaborating with patient organizations where relevant

- Regulatory navigation and REK application support: NorPedMed can assist sponsors in preparing ethics applications (REK), now a sponsor responsibility under the EU Clinical Trials Regulation (EU CTR) and CTIS system. Navigating national procedures and Norwegian regulatory expectations can be challenging for sponsors unfamiliar with the local landscape. Our team can provide practical guidance to ensure submissions align with national requirements and timelines

- Tailored informed consent materials: Informed consent documents must be adapted to Norwegian legal standards and cultural expectations. NorPedMed helps sponsors develop materials that are compliant and family-friendly, ensuring clear communication in line with how information is typically presented and understood in Norway.

- NorPedMed helps sponsors de-risk pediatric trials from the start, offering predictable timelines, robust ethics, and high-quality results.

NorPedMed is Norway’s gateway to European pediatric trials, actively contributing to a more unified and effective trial landscape across the continent. As a core partner in EU initiatives like PedCRIN and conect4children (c4c) and its permanent successor c4c-s, NorPedMed offers sponsors access to harmonized processes, shared standards, and a nationwide coordinated system aligned with international priorities.

A majority of medicines prescribed to children are still used off-label, often with insufficient or uncertain evidence to support their use. Nevertheless, pediatric clinical trials remain limited across Europe. To address this, the EU Pediatric Regulation and major initiatives like conect4children (c4c), PedCRIN, and Enpr-EMA have been launched.

NorPedMed is fully embedded in this collaborative landscape, as core partner in the c4c project and the newly established conect4children stichting(c4c-s) based in the Netherlands. 

NorPedMed contributes to harmonized trial delivery across Europe by operating in line with shared frameworks and standards:

- Harmonized procedures and quality standards are implemented and applied, ensuring consistent and efficient trial conduct in line with European frameworks and regulatory requirements

- Sponsor engagement is streamlined, both nationally and within EU-level networks, such as c4c-s and the relevant pediatric expert networks

- National tools for feasibility, contracting, and protocol review are developed in alignment with international best practices

- Operational support is consistent from startup to trial completion, mirroring expectations across the European research landscape

Through NorPedMed, sponsors gain access to a national system aligned with international priorities, committed to ethical, efficient, and child-centered research.