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Training

Within our headquarter facilities in Oslo, there is a huge conference centre with many differently sized auditoria, seminar rooms and class-rooms. This enables us to host seminars with a capacity of up to 100 people. Thus, we regularly arrange scientific and operational seminars on topics related to clinical trials, regulatory affairs and statistical methodology with the objective of offering a meeting place for the local clinical research society. In addition, we are proud to present our regular training courses within GCP-related topics, training courses that have been built on almost 30 years experience with GCP. In addition to priodic training courses, our team is able to tailor-make specific courses for smaller groups, e.g. project-specific training of study staff, where examples and cases will be taken from the specific study protocol.

 

REGULAR TRAINING COURSES

GCP Training for investigators, study nurses and monitors
These courses are mainly focused on educating study nurses, investigators and site staff in the discipline of good clinical practice and in particular the resonsibilities associated with being an investigator (site). The course includes theoretical lectures and practical workshops. We are also able to adapt a course for your specific needs. Courses can be modified to last half day, full day, or 2 days, depending on clients' wish and needs. We are also able to tailor examples and cases to a specific protocol/study. 

Accredited University course in Medical Statistics
Online statistical training is available through Smerud Statinet AS (Norwegian). This course is presented in collaboration with the Medical Faculty, University of Oslo. Currently we arrange five courses, all of which are a part of the Norwegian Medical Association's continued medical education programme.

 

To find out more about any of our seminars or training courses, please contact us.

 

 

 

 

 

 

 

Services

Smerud excels in all services required to develop a product; from strategy planning, to processing marketing authorisation.

We are highly competitive in quality, time and cost - particularly as we can provide clients with reliable and documented feasibility information before costly drug development can begin.

For more information on any of the services listed below, please contact us.

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

  • Seminars
  • Training courses
  • [For more details on these, please visit our Training page.]

Locations

Smerud's head office is based in Norway, supported by eight locally operating business units.

OFFICES

Please click on the location you would like to know more about.

  

For full contact details for each national office, please visit our Contact page.