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SERVICES
Clinical Research Support

  • Feasibility assessment of protocols


  • Writing protocols, patient information and consent forms


  • CRF design


  • Translation of research related material for the relevant national regulatory institutions and for the potential patients


  • Trial permission/approval from the National Drug Agency and the National Ethics Committee


  • Consultations on local variations of GCP and other regulatory documents


  • Organising of investigator meetings


  • Experienced investigator identification, selection of investigators according to criteria defined by SMP and/or the Sponsor


  • We can offer investigators or freelance monitors

  • Site identification, evaluation, selection and initiation


  • Negotiating the right hospital agreements


  • Project management


  • Drug import and distribution


  • Monitoring and organising bioequivalence studies and clinical trials phase II - IV


  • Standard operating procedures designed to fully meet international guidelines on clinical trials and are adapted to Romanian conditions


  • Audit and Quality Control of investigator centers during the clinical studies


  • Close-out visits and final reports (Clinical Study Report)

We are fully prepared to contribute to ongoing trials.

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