Safety Comes First

Dokumeds has an extensive background in managing all aspects of drug safety and pharmacovigilance monitoring. Phamacovigilance during a clinical study is integrated into our study service, with the appropriate specialists assigned based on services contracted. For individual services, or a comprehensive safety program, Dokumeds can help.

Our services include:

EudraVigilance

• Registration within the EudraVigilance database (EVCTM)
• Responsible person for EudraVigilance
• EudraVigilance Medical Production Dictionary updates (EMPDU)

Adverse Event (AE) and Adverse Drug Reaction (ADR) handling

• Receipt, initial assessment and follow up with reporter
• Assessment of seriousness, expectedness and causality
• Narrative writing
• Reporting to Sponsor and entering into Sponsor’s or Marketing Authorization Holder's (MAH's) safety database
• MedDRA coding
• Source records maintenance
• Literature review for adverse drug reactions

Expedited submissions to Competent Authorities (CAs)

• Using EudraVigilance Webtrader (with or without safety database, in E2B format)
• Using Sponsor’s / MAH safety database and gateway

Other submissions

• Periodic safety update (e.g. Annual Safety Reports (ASRs), Periodic Safety Update Reports (PSURs), submission to Ethics
• Committees / Principal Investigators / Competent Authorities
• Suspect Adverse Reaction Reports (CIOMS) creation
• Expedited report submission to Ethics Committees / Principal Investigators

SOPs, Documentation and Training

• Development and Adaptation of Safety SOPs
• Development and Adaptation of training materials
• Personnel training
• Risk management plan
• Detailed Description of PharmacoVigilance System