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EastHORN Phase 1 Unit

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An overview of the EastHORN phase 1 unit

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EastHORN Phase 1 Unit

  1. 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. 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

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