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Pharmacovigilance by Dr. Notghi Contract Research
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Dr. Notghi Contract Research in Berlin Our Medical Drug Safety Services Call Centre Drug Safety Data Entry Literature Surveillance Analysis and Reporting Medical writing IT Services
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Dr. Notghi Contract Research in Berlin AE/SAE Data Collection & Processing Safety DB AEs/SAEs entered to DB Literature Investigator (Europe, USA, etc.) Call Centre Dr. Notghi CRO Drug Safety Unit
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Dr. Notghi Contract Research in Berlin 24-7 and multilingual Call Centre Services Data Collection Registration Data Entry SAE transfer data to Safety Database System
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Dr. Notghi Contract Research in Berlin Web Portal Secure web-based portal for data collection: Product Complaints Medical/Technical Inquires Adverse Events
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Dr. Notghi Contract Research in Berlin Product and Clinical Trial Safety Monitoring AE/SAE Reports (per fax, email, mail) Data Entry by trial specific trained personnel Quality Check Monitor/Investigator contact Analysis and Reporting
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Dr. Notghi Contract Research in Berlin Literature Surveillance Process Product specific literature database search Librarian services Data Entry Quality Check Analysis and Reporting
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Dr. Notghi Contract Research in Berlin Analysis and Reporting Client Dr. Notghi CRO Drug Safety Unit Safety Data Retrieval / Data Mining Lit. DB Safety DB Safety Data Retrieval and Data Mining
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Dr. Notghi Contract Research in Berlin IT Services for Medical Drug Safety Validation of e.g. ARGUS 3 Database Maintenance Literature database set-up Programming, etc.
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Dr. Notghi Contract Research in Berlin Quality Assurance Compliance with regulatory requirements Client & internal quality assessments Training QC Checks Ensuring consistency and validity, coding accuracy, clinical assessment
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Dr. Notghi Contract Research in Berlin Client Specific Compliance Corporate Standard Operating Procedures Client SOPs and Working Procedure Client Specific Templates Client Specific Trial Management Systems and DM Systems
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Dr. Notghi Contract Research in Berlin Training Providing hands-on training for ARGUS Concepts and pharmacovigilance procedures MedDRA and GCP/ICH training
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Dr. Notghi Contract Research Zimmerstrasse 55 D- 10117 Berlin-Mitte Germany Tel. +49-30-46064 780 Fax: +49-30-46064 733 Email: contact@notghi.com Homepage: www.notghi.com Contact
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