Studies in Eastern Europe
- Cost-saving trials (phase II-IV) according to GCP, FDA standard (e.g. for regulatory requirements in EU / US) in Hungary, Poland, Czech Republic, Slovakia, Croatia, Macedonian, Yugoslavia, Romania and Russia
- Fast patient recruitment and high motivation of investigators and patients
- Investigational sites with international experience: large investigator pool in clinics / out patient clinics
- Local monitors (ten): physicians, pharmacists, local offices
- All procedures with authorities (submission, approval, translations, customs regulations)
- Project management by experienced physicians (native speakers) centrally at PHARMALOG
Expansion of our Eastern European Clinical Research Services to two further countries:
the Russian Federation and the Republic of Georgia (Caucasus).
Over ten years' experience of conducting studies in Eastern Europe with well-established contacts
A senior project manager with extensive experience in pharmaceutical and contract research industries and practical know-how gained in conducting studies in Eastern European countries is working for PHARMALOG to expand its Eastern European clinical research business.
Among the many advantages of carrying out clinical studies in these regions are: accelerated patient recruitment, enthusiastic investigators, highly motivated patients, as well as the investigators’ reliability and excellent working standards.
We combine over ten years' experience and the successful completion of approximately 40 clinical studies, phases II – IV in: the Czech Republic, Hungary, Poland, Slovakia, Croatia, Macedonia, Yugoslavia, Romania, as well as the Russian Federation (Western- and Central Russia) and Georgia.
Our full services include our usual expertise (study protocol development/ statistics/ data management) as well as all aspects of regional regulatory work (regulatory and ethics committee submissions), local logistics (customs’ handling for drug import and biological samples export, sample shipments), investigator selection, site training, close site monitoring with highly dedicated, well-trained, local native-speaking monitors.
Our study experience in Eastern Europe with 40 successfully completed studies, including seven studies carried out in Russia and Georgia, guarantees our sponsors a reliable and experienced study conduct within the agreed timelines.
We would be more than happy to provide you with a cost estimate for your planned trial.