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. 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. East Health Outcomes Research Network PHASE I/IIA ICH, GCP, and GLP compliant; ISO 9001:2008 Accredited For more information please contact: Europe and Asia/Pacific: Chris Birch +44 1280 816919 [email protected] North America: Leonard Gold +1 908 317 2846 [email protected] Facilities Include Equipment Includes Study Specific Capabilities Approx. 6,300 M² Area Refrigerated Drug Storage Phase I (Healthy Volunteer) 6 Examination Rooms sample preparation room Refrigerated Centrifuge Phase IIA (Special Patient Populations including cancer and diabetic patients) 28 Beds Programmable Freezers (-86° C) Pharmacokinetic 24/7 On-Site Physician Back-up Generator (UPS) Pharmacodynamic Hospital Laboratories (Czech reference lab) High Speed Internet Drug Interaction Hospital-based ICU X-Ray, MRI,CT & DEXA Scanners linked to PACS available in hospital Bioequivalence 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
EastHORN Phase 1 Unit
Jun 20, 2015
An overview of the EastHORN phase 1 unit
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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.
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.
East Health Outcomes Research Network
PHASE I/IIA
ICH, GCP, and GLP compliant; ISO 9001:2008 Accredited
For more information please contact:
Europe and Asia/Pacific:Chris Birch
+44 1280 [email protected]
North America: Leonard Gold
+1 908 317 [email protected]
Facilities Include Equipment Includes Study Specific Capabilities
Approx. 6,300 M² Area Refrigerated Drug Storage Phase I (Healthy Volunteer)
6 Examination Roomssample preparation room
Refrigerated Centrifuge Phase IIA (Special Patient Populations including
cancer and diabetic patients)
28 Beds Programmable Freezers (-86° C) Pharmacokinetic
24/7 On-Site Physician Back-up Generator (UPS) Pharmacodynamic
Hospital Laboratories (Czech reference lab)
High Speed Internet Drug Interaction
Hospital-based ICUX-Ray, MRI,CT & DEXA Scanners linked
to PACS available in hospitalBioequivalence
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
List of Services
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
Medical Writing Experimental Drug importing (Russia) Protocol review or writing Translations Study Documentation including all trial related documents
(informed consent, patient Information leaflets) Investigator Brochures CRF design and printing Integrated Trial Reports Local Trial Marketing
Regulatory ServicesRegulatory Board submissionsSite Ethics Committee SubmissionsSite & Investigator ContractsStudy materials Pharmacovigilance
Client Managed Clinical StaffProject ManagementLead CRAClinical Research Asociate Clinical Project Assistant services
Post Marketing Pharmacovigilance Maintenance of the electronic and paper ADR Database Validation of the ICSRs and reporting of the applicable
cases via applicable means Periodical clinical evaluation of ADRs in ADR database Literature reports Preparation of PSURs Reporting to EudraVigilance system, registering to EV system. Providing QPPV services
Biostatistics and Data Management
Phase I-IV Monitoring by native, English speaking, highly
experienced CRAs
Moscow
Talinn
Riga
Vilnius
Warsaw
Prague
BratislavaBudapest
Zagreb
SarajevoBucharestBelgrade
SofiaSkopje
Kiev
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