Drug Safety Pharmacovigilance

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Pharmacovigilance by Dr. Notghi Contract
Research
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Our Medical Drug Safety Services

• Call Centre
• Drug Safety Data Entry
• Literature Surveillance
• Analysis and Reporting
• Medical writing
• IT Services

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AE/SAE Data Collection Processing
Dr. Notghi CRO Drug Safety Unit
Safety DB
AEs/SAEs entered to DB
Literature
Call Centre
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Call Centre Services
Data Collection
Registration Data Entry
SAE transfer data to Safety Database System
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Web Portal

• Secure web-based portal for data collection
• Product Complaints
• Medical/Technical Inquires
• Adverse Events

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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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Literature Surveillance Process

• Product specific literature database search
• Librarian services
• Data Entry
• Quality Check
• Analysis and Reporting

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Safety Data Retrieval / Data Mining
Dr. Notghi CRO Drug Safety Unit
Safety Data Retrieval and Data Mining
Analysis and Reporting
Client
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IT Services for Medical Drug Safety

• Validation of e.g. ARGUS 3
• Database Maintenance
• Literature database set-up
• Programming, etc.

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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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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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Training

• Providing hands-on training for ARGUS
• Concepts and pharmacovigilance procedures
• MedDRA and GCP/ICH training

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Contact
Dr. Notghi Contract Research Zimmerstrasse 55 D-
10117 Berlin-Mitte Germany Tel. [phone]
780 Fax [phone] Email
contact_at_notghi.com Homepage www.notghi.com