Phase I-IIa Patient Studies

PRA has a strong strategic presence in the Central European countries of Poland, Czech and Slovak Republics, and Hungary. PRA coordinates our dedicated Central and Eastern European (CEE) group from our Berlin office. The CEE group focuses on:

• Phase I studies in special patient populations, primarily PK studies in patients with impaired hepatic or renal function
• Phase I-IIa studies in:
  • oncology
  • endocrinology (i.e. Diabetes Mellitus, obesity)
  • rheumatology
  • neurology

It is often difficult to motivate patients to come to a clinical research center. Through our CEE group, PRA is using an innovative business model to bring the center to the patients. We essentially establish a Phase I study environment in central medical facilities that specialize in the treatment of the target patient population. Residing physicians in these hospitals are able to recruit high volumes of patients and are supported by extensive networks of referring GPs. This can vary from single center studies to multinational settings.

PRA provides and maintains staff, equipment, SOPs, and documentation at the center while performing the clinical trial in close collaboration with local investigators. Utilizing this model, PRA can plan and perform all studies in conformity with the clinical study protocol and in full compliance with GCP. Using this so-called 'Virtual Phase I' model, patients participating in a clinical trial remain under the medical care of the residing physician for the period of the study. PRA remains responsible for all study-related activities from start to finish.

PRA has successfully used this 'Virtual Phase I' model for more than 15 years, having completed over 160 studies. PRA's CEE group has developed networks of clinics, investigators and referring specialists with proven access to patients. These networks help to ensure fast and effective recruitment. In addition to this 'virtual' setup, PRA operates a separate 8-bed unit located within a nephrology clinic in Prague, dedicated to conducting Phase I patient studies.

Our experienced Berlin-based project managers coordinate clinical studies and:

• track studies to ensure they are completed on schedule
• coordinate all regulatory submissions across various countries via our local offices
• manage IRB and CA (Competent Authority) submissions
• support our clients through the entire approval process

While the approval process for these studies typically takes 60 days, PRA offsets this longer process through accelerated patient enrollment as compared to western countries.

For more information on our EDS group in Central and Eastern Europe please contact:

Christian Reh, M.D., Ph.D.
Vice President EDS CEE
Strasse Des 17.Juni 106/108
10623 Berlin
Germany
+49 30 323049-030
RehChristian@PRAIntl.com