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Pharmacovigilance by Dr. Notghi Contract Research.

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Presentation on theme: "Pharmacovigilance by Dr. Notghi Contract Research."— Presentation transcript:

1 Pharmacovigilance by Dr. Notghi Contract Research

2 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

3 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

4 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

5 Dr. Notghi Contract Research in Berlin Web Portal Secure web-based portal for data collection: Product Complaints Medical/Technical Inquires Adverse Events

6 Dr. Notghi Contract Research in Berlin Product and Clinical Trial Safety Monitoring AE/SAE Reports (per fax, , mail) Data Entry by trial specific trained personnel Quality Check Monitor/Investigator contact Analysis and Reporting

7 Dr. Notghi Contract Research in Berlin Literature Surveillance Process Product specific literature database search Librarian services Data Entry Quality Check Analysis and Reporting

8 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

9 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.

10 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

11 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

12 Dr. Notghi Contract Research in Berlin Training Providing hands-on training for ARGUS Concepts and pharmacovigilance procedures MedDRA and GCP/ICH training

13 Dr. Notghi Contract Research Zimmerstrasse 55 D Berlin-Mitte Germany Tel Fax: Homepage: Contact


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