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Our experienced team offers the following services:
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Clinical Trials
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Planning and monitoring of clinical trials, biometrical elaboration of data and documentation support |
PMS
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Planning and performance of Post Marketing Surveillance Studies |
Statistical Analysis
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Statistical Analysis of clinical studies and Post Marketing Surveillance Studies |
Data management
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Database design and validated data entry |
MedDRA
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MedDRA coding for trials, pharmacovigilance and PSURs |
| Training |
Seminars in biometrics for clinical trials |
Project management
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Planning, implementation and controlling of projects |
Quality management
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Creation, documentation and maintenance of your QM system according to EN ISO 9001:2000 and EN ISO 13485:2003. |
Quality assurance
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Preparation and performance of audits |
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Marketing authorisation applications, eCTD, reimbursement applications and
pharmacovigilance www.aracgmbh.com
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This overview shows the areas we cover. Our staff with extensive expertise in the pharmaceutical field can
help with your projects.
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© Dr. Robert Heinz & Partner GmbH,
Medical Consulting, A-1070 Vienna, Kaiserstrasse 84/10
All rights reserved. Suggestions and technical support under |