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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.]