Smerud
Smerud Medical Research International AS (SMERUD) is a European drug development company and contract research organisation (CRO) with headquarters in Oslo, Norway. The core competence is strategic drug development including regulatory affairs planning. They manage clinical exploratory trials, proof-of-concept trials (phase IIa) as well as pivotal phase III trials, and they liaise with regulatory agencies world-wide to agree study plans. SMERUD has been involved in more than 1000 clinical trials. The core business idea is to develop biotech drug candidates in collaboration with small-to-medium sized biotech partners and academic institutions.
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| Type | Private |
| Industry | Pharmaceuticals |
| Headquarters | Drammensveien 41, N-0271 Oslo, Norway |
| Number of employees | 51-200 employees |
Services
CLINICAL TRIAL MANAGEMENT
- Planning of clinical development programmes
- Feasibility studies
- Setting up and management of trial centres
- Patient recruitment
- Periodic monitoring
- Closing of trial centres
PROJECT FUNDING
- Research grants
- Venture capital
- Market analyses
- Project strategy
CONSULTING
- Clinical development programmes
- Regulatory strategy
- Licensing
- Patents
- Local advice - regulatory and ethics
DATA MANAGEMENT
- Case report form design and production
- Database design
- Data entry
- Data validation
BIOSTATISTICS
- Study design
- Sample size estimations
- Power analysis
- Randomisation
- Analysis planning
- Statistical analysis and reports
MEDICAL WRITING
- Study protocols
- Study reports
- Articles for publications
- Review articles
- Investigator brochures
- Clinical summaries / clinical overview
- Regulatory dossiers
REGULATORY AFFAIRS
- Marketing authorisation applications
- Local translations and harmonisation of texts
- Clinical trial applications
- Pharmacovigilance
QUALITY ASSURANCE
- Site audits
- In-house audits
- Standard operating procedures - development and revision
EDUCATION
- Seminar
- Training courses
Top Authors
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