Drug safety

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Safety-specific medical writing

The Drug Safety Department with 5 MDs, all previously employed by pharmaceutical companies prepares:

• Periodic safety update reports (PSURs)
• Annual safety reports (ASRs)
• Risk analyses for authorities
• Safety analyses of studies and post-marketing observations
• Safety-specific parts of study protocols, study reports and other regulatory documents containing safety information
• Templates for study protocols in specific indications
• Check of CRFs capturing safety information
• Case narratives

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Safety services during clinical trials

Pertinent activities encompass:

• Collection, documentation and follow up of SAEs (>150 studies, >30,000 patients)
• SAE processing in safety database
• Qualified medical review of SAEs
• AE-data entry in clinical trial database and query generation
• Validation and analysis of AE data
• AE-listings (CIOMS II-listings, frequency tables, etc.)
• Data reconciliation of pharmacovigilance and clinical trial databases
• Science reviews
• Project-specific AE-guidelines and correspondence with investigators
• Drug-safety-specific training and support of study responsibles
• Safety surveillance and risk prevention

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Post-authorization safety services

Pertinent activities are:

• Receipt, assessment and follow-up of spontaneous reports (SADRs)
• Analysis of international specialized literature
• Qualified medical evaluation and assessment of reported SADRs and literature cases
• ADR processing in pharmacovigilance database, within required timeframes
• Surveillance of risk profile
• Risk prevention and management strategies
• Drug safety consulting to study responsibles

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Reporting of safety information to authorities and coding

Activities are:

• Generation of CIOMS I / MedWatch reports
• Case reports to authorities according ICH-E2B format
• Management and dispatch of expedited reports
• Coding using MedDRA, WHO, ICD, and sponsor-owned thesauri
• Code control
• Thesaurus management
• Coding principles manual