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. We offer Pre and Post Marketing Pharmacovigilance Services.
Our services include:
EudraVigilance
- Registration within the EudraVigilance database (EVCTM)
- Responsible person for EudraVigilance
Adverse Event (AE) and Adverse Drug Reaction (ADR) handling in clinical trials and Post-marketing
- Safety Database set-up and maintenance in Clinical Trials
- Receipt, initial assessment (of seriousness, expectedness and causality) and follow up
- Local Pharmacovigilance contact person with National Competent Authorities
- Literature review for Adverse Drug Reactions
- Narrative writing and reporting to Sponsor and entering into Sponsor’s or MAH’s safety database
- Source records maintenance
Expedited submissions to Competent Authorities (CAs)
- Via EudraVigilance
- Via National Competent Authorities
Aggregated reports and Other submissions
- Periodic safety update (e.g. Annual Safety Reports (ASR), Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSURs)) submission to Ethics Committees / Principal Investigators / Competent AuthoritiesCommittees / Principal Investigators / Competent Authorities
- Suspect Adverse Drug 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
- Development of Safety Management plan and Risk management plan
- Development of Safety Reporting plan
- Sales representative safety training
- Clinical Trial Site personnel training
- Detailed Description of PharmacoVigilance System
Medical Device Vigilance
- Set up and maintenance of complete MDV system
- Collection, investigation, and assessment of medical device incidents
- Medical device incident reports submission to Competent Authorities
- Medical device incidents records maintenance
- Development of Periodic Summary Reports