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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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