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
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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
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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
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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
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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
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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.
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| 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. |
