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WHY SMP ROMANIA?
Approvals
  • Quick start-up and short regulatory approval process
  • National approval is usually obtained within 30-60 days
  • Real-time decision of the scientific consultants assigned by the National Drug Agency and the National Ethics Committee
  • Smooth import procedure
  • Supportive hospital administrators
Logistical facilities
  • Presence of all major courier networks facilitating fast drug delivery and bio sample export channels
  • Secure storage facility of drugs, documents, samples and other materials
  • Management of the research centres and distribution of the materials to these units
  • ISDN lines, LAN, GSM connection, Fax, copier
  • Internet based data collection system for clinical trials
     SMP personnel
  • CRAs with up to six years of participation in multicenter clinical trials
  • CRAs are qualified physicians
  • We have the experience to avoid frequent difficulties and problems that may delay and compromise the results
  • Knowledge of national legal stipulations
  • Good cooperation with people in charge of the relevant national institutions
  • Regularly training of Monitors
Romanian patients
  • Rapid, reliable and considerable patient enrollment into Phase II-IV of clinical trials, with all types of pathology
  • Very few to none lost-to-follow-up patients and low refusal rate
  • Access to a large number of patients in major hospitals
  • High number of patients without pre-treatment or first time diagnosed subjects
  • Low internal migration allows easy long time follow-ups
  • High compliance with study requirements
Romanian physicians
  • High level of medical practice and professional culture
  • Highly motivated to participate in clinical studies
  • All investigators are registered MDs and all of the PIs are MD-PhD
  • Many of them have experience with GCP regulations through previous successful clinical trials
    Costs
  • Investigator fees are split up between the clinics and participating doctors
  • The investigator fees are directly proportional with the salary levels in Romania = much lower than in the EU region
  • The comparative costs on a patient are considerably lower than in any EU country
  • It is an undisputable fact that conducting clinical trials in Romania is considerably economical than in any Western and Central European country.
We strongly affirm that the high quality of data, short duration of the study and economical advantage are the best aspects for choosing SMP Romania.
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