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Pharmacovigilance Services
AnaCipher CRO offer end-to-end PV services and Services from clinical trial development to post-marketing Services for Pharmaceutical, Medical device and Biotech companies.
End-to-end Pharmacovigilance services include:
- ICSR (Individual Case Safety Report Management)
- Aggregate Report Writing
- Signal Detection Management
- Risk Management Activities
- Literature Search
- Medical Information Call Center
Other Services Included
- QPPV services
- Audit and Inception Support
PHARMACOVIGILANCE SERVICES
ICSR (Individual Case Safety Report Management)
We process adverse events arising from clinical trials as well as those arising from post-marketing sources.
- Triage / Duplicate Search
- Data Entry
- Case Narrative
- Medical Review
- QC
- Submission
Aggregate Report Writing
We can support the document preparation and submission of Aggregate safety reports in both pre-authorization and post-authorization.
- Periodic Safety Update Report (PSURs)
- Periodic Adverse Drug Experience Report (PADERs)
- Periodic Benefit Risk Evaluation Report (PBRER)
- Development safety Updated Report (DSUR)
Signal Detection Management
We can support on continuous and periodic signal detection & management are written in accordance with GVP: Module IX – Signal management for products both pre- and post-authorization.
Qualitative Analysis
- Quantitative Analysis
- Signal assessment reports
- Signal Tracking
Risk Management Activities
We can support you in writing the Risk Management Plan that is required for most of the products as part of a marketing authorization application.
Literature Screening
Literature searches should be constructed in such a way to identify both Individual Case Safety Reports (ICSRs) of Adverse Reactions and relevant safety information (e.g. class effects) for consideration in periodic reports.
Medical Information Call Center
- 24*7 support
- Qualified HCPs for MICC
- Inbound MI / AE / PQCs
- Follow-up Calls
- Targeted Questionnaires and FAQs, A globally integrated, validated database.
