1. East Health Outcomes Research Network
An East European Full Service CRO with an Impeccable Record
in Patient Recruitment for Clinical Trials from Phase I to Phase IV.
Not only has EastHORN NEVER failed to reach a recruitment target; in multi vendor trials EastHORN has rescued studies by
providing additional patients to supplement other, under performing vendors (averaging 140% of initial recruitment target).
EastHORN staff is highly experienced and studies to date include:
Oncology Cardiovascular Gastroenterology Diabetes, Respiratory,
Breast Cancer Deep vein Thrombosis Upper GI Bleeding
Immunology, CNS,
Colorectal Cancer Hypertension Ulcerative Colitis
Prostate Cancer Pulmonary Embolism Crohn’s Disease Paediatric & Medical Devices
Please see our website for further examples of our therapeutic experience. www.easthorn.eu
EastHORN is able to provide all the regulatory and medical writing services required for undertaking a clinical trial in CEE. We
work closely with the regulatory bodies in each country using native English speaking staff and a dedicated start up team for
each study. A large percentage of our staff are medically qualified and experienced, therefore able to help in protocol design
(and translation) if required.
EastHORN takes great pride in its relationships with sponsor companies, sites and investigators and this is highlighted through
our clinical trail patient recruitment results.
We would welcome the opportunity to help you in the development of your clinical projects, large or small. Please do not hesitate
to get in touch to find out more about us or to arrange an informal meeting.
Chris Birch – Global Business Development Director
Chris.birch@easthorn.eu +44 1280 816919 (office), +44 7973 287751 (mobile)
2. List of Services
Phase I – IV Clinical Trial Management Regulatory Services
28 bed Phase I Unit – Prague – Czech Republic Regulatory Board submissions
Site Ethics Committee Submissions
Medical Writing Site & Investigator Contracts
Experimental Drug importing (Russia) Study materials
Protocol review or writing Pharmacovigilance
Translations
Study Documentation including all trial related documents Client Managed Clinical Staff
(informed consent, patient Information leaflets) Project Management
Investigator Brochures Lead CRA
CRF design and printing Clinical Research Asociate
Integrated Trial Reports Clinical Project Assistant services
Local Trial Marketing
Post Marketing Pharmacovigilance Talinn
Maintenance of the electronic and paper ADR Database Riga Moscow
Validation of the ICSRs and reporting of the applicable Vilnius
cases via applicable means Warsaw
Periodical clinical evaluation of ADRs in ADR database Prague Kiev
Literature reports Bratislava
Budapest
Preparation of PSURs Zagreb
Reporting to EudraVigilance system, registering to EV system. Belgrade Bucharest
Sarajevo
Sofia
Providing QPPV services Skopje
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
