Page 4: A Single Point of Contact for Clinical Trials in Norway
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.