The Thomayer University Hospital Phase I Unit in Prague, Czech Republic offers facilities and equipment for conducting Phase I and Phase IIA clinical trials. [1] The 6,300 square meter facility has examination rooms, 28 beds, laboratories, and ICU capabilities. [2] Equipment includes refrigerated storage, centrifuges, freezers, and imaging devices. [3] The unit is capable of pharmacokinetic, pharmacodynamic, drug interaction, and other types of studies. It is conveniently located near the Prague airport and has medical and clinical staff on site.

1. East Health Outcomes Research Network
PHASE I/IIA
Established and operated in conjunction with EastHORN Clinical Services in CEE, a full-service CRO, Thomayer University
Hospital Phase I Unit in the Czech Republic offers high-value full-service solutions for First-In-Man clinical trials.
Facilities Include Equipment Includes Study Specific Capabilities
Approx. 6,300 M² Area Refrigerated Drug Storage Phase I (Healthy Volunteer)
6 Examination Rooms Phase IIA (Special Patient Populations including
Refrigerated Centrifuge
sample preparation room cancer and diabetic patients)
28 Beds Programmable Freezers (-86° C) Pharmacokinetic
24/7 On-Site Physician Back-up Generator (UPS) Pharmacodynamic
Hospital Laboratories
High Speed Internet Drug Interaction
(Czech reference lab)
X-Ray, MRI,CT & DEXA Scanners linked
Hospital-based ICU Bioequivalence
to PACS available in hospital
Emergency Management EKG Monitoring Bioavailability
Secure Drug Storage Blood Draw Stations Renal Insufficiency
Kitchen Oxygen Hepatic Insufficiency
Patient Lounge & Diner Defibrillator/AED Metabolic & Nutritional Studies
Conveniently located in the heart of Prague, just 30 minutes from the Ruzyne International Airport, the unit is both an inpatient
and outpatient facility. Staff Includes, 21R.N.s, 6 M.D.s, 1 Pharm. D, 1 Anesthesiologist.
For more information please contact:
Europe and Asia/Pacific: North America:
Chris Birch Leonard Gold
+44 1280 816919 +1 908 317 2846
chris.birch@easthorn.eu leonard.gold@easthorn.eu
ICH, GCP, and GLP compliant; ISO 9001:2008 Accredited

2. List of Services
Phase I-IV Regulatory Services
Monitoring by native, English speaking, highly Regulatory Board submissions
experienced CRAs Site Ethics Committee Submissions
Site & Investigator Contracts
Study materials
Medical Writing Pharmacovigilance
Experimental Drug importing (Russia)
Protocol review or writing Client Managed Clinical Staff
Translations Project Management
Study Documentation including all trial related documents Lead CRA
(informed consent, patient Information leaflets) Clinical Research Asociate
Investigator Brochures Clinical Project Assistant services
CRF design and printing
Integrated Trial Reports
Local Trial Marketing
Talinn
Post Marketing Pharmacovigilance Riga
Vilnius
Moscow
Maintenance of the electronic and paper ADR Database
Warsaw
Validation of the ICSRs and reporting of the applicable Prague Kiev
cases via applicable means Bratislava
Periodical clinical evaluation of ADRs in ADR database Zagreb
Budapest
Literature reports Belgrade Bucharest
Sarajevo
Preparation of PSURs Sofia
Skopje
Reporting to EudraVigilance system, registering to EV system.
Providing QPPV services
Biostatistics and Data Management
EastHORN Clinical Services in CEE, U Družstva Práce 43, 140 00 Praha 4, Czech Republic
Tel.: +420 244 462 241 Fax: +420 244 462 271
www.easthorn.eu