Smerud Medical Research Denmark
Smerud Medical Research Group (SMERUD) is a leading full-service clinical Contract Research Organisation (CRO) operating mainly in Northern Europe, providing comprehensive clinical trial services to biotech, pharma, med-tech, and academic sponsors. With headquarters in Norway and offices across Europe and the US, SMERUD specializes in early-phase clinical trials, especially in oncology, rare diseases, and precision medicine, emphasizing high-quality services, local presence, and a strong ethical commitment. The company has a rich history since 1993, with extensive experience in drug development, regulatory affairs, data management, biostatistics, and medical writing, and actively engages in co-development, grants, and internal R&D projects.
Industries
Nr. of Employees
small (1-50)
Products
Full-Service Clinical Trial Services
Smerud Medical Research Group (SMERUD) is a leading, commercial clinical Contract Research Organisation (CRO) providing full-service clinical trial services to biotech, pharma, med-tech, and academic sponsors primarily in Northern Europe.
Full-Service Clinical Trial Services
Smerud Medical Research Group (SMERUD) is a leading, commercial clinical Contract Research Organisation (CRO) providing full-service clinical trial services to biotech, pharma, med-tech, and academic sponsors primarily in Northern Europe.
Services
Full-service clinical trial operations including project management, monitoring, feasibility, and site management across all trial phases.
Regulatory strategy and dossier preparation, local regulatory support, agency interaction preparation and QA support.
eCRF design, database build and validation, data cleaning, coding and final database QC using validated EDC/SaaS platforms.
Statistical design, sample size estimation, randomization generation, analysis per SAP, and production of TLFs and regulatory-ready outputs.
Safety monitoring services including SAE/SUSAR processing, medical review, safety reporting registration and annual safety reports.
Preparation of regulatory dossiers, clinical study protocols, CSRs, manuscripts and grant proposals by senior scientific writers.
Full-service clinical trial operations including project management, monitoring, feasibility, and site management across all trial phases.
Regulatory strategy and dossier preparation, local regulatory support, agency interaction preparation and QA support.
eCRF design, database build and validation, data cleaning, coding and final database QC using validated EDC/SaaS platforms.
Statistical design, sample size estimation, randomization generation, analysis per SAP, and production of TLFs and regulatory-ready outputs.
Safety monitoring services including SAE/SUSAR processing, medical review, safety reporting registration and annual safety reports.
Preparation of regulatory dossiers, clinical study protocols, CSRs, manuscripts and grant proposals by senior scientific writers.
Expertise Areas
- Clinical trial management
- Pharmacovigilance and medical monitoring
- Clinical data management and EDC implementation
- Biostatistics and statistical programming
Key Technologies
- Electronic data capture (EDC) and eCRF systems
- RTSM (randomization and trial supply management)
- CDISC standards (CDASH/SDTM/ADaM)
- MedDRA and WHODrug coding