Our Team is specializes in the management of ICSRs originating from various sources for human and veterinary pharmacovigilance:
- Spontaneous
- Clinical/Solicited
- Literature
- Health Authority
- E2B
- Legal
- Social Media
Single Cases
The scientists and physicians at Vin-Wal have deep expertize in management of activities across the spectrum for ICSRs:
- Case Intake & Triage
- Case creation/Duplicate detection
- Data entry & MedDRA coding
- Quality Check
- Medical Review
- Follow-up queries and tracking
Vin-Wal deploys unique work management tools to ensure extremely high compliance and well formulated strategy to deliver high quality services.
Vin-Wal also offers the following allied services in support of case processing:
- Compliance and Quality Monitoring
- Independent Quality Review
- SAE Reconciliation
- Management of bolus cases
- Migration of safety data/legacy data
Aggregate Reports
Vin-Wal has best-of-class capabilities for the analysis of grouped/aggregate data for a drug over a prolonged period of time (months or years) and the subsequent incorporation of such data into prescribed reports on behalf of our clients. These reports include:
- PBRERs/PSURs
- PADERs
- PSUR Addendum Reports
- PSUR LL Reports
- ACOs
- IPSRs
- SUSAR Reports (six-monthly)
- DSURs
- Drug Safety Reports/Ad-hoc reports
- PQC reports/HHEs
For all the reports above, we help determine strategy, review and analyze data/literature/signals, provide guidance, and review and implement comments.
Additional services, such as generation of listings for Aggregate Reports, Clinical Expert Statements and Independent Quality Reviews, are also offered.
Medical Writing
Vin-Wal team of experienced scientists and physicians offer services for preparing
- RMPs and RMP Updates
- Safety Narratives for Clinical Study Reports & Protocols
- Clinical Summaries/Product Feasibility Reports for Medical Devices
- Guided Questionnaires
- Company Core Safety Information
Safety Physicians
We offers the services of dedicated safety physicians to its clients. These physicians, while employed by Vin-Wal, are a part of the clients´ global product teams and support the following areas:
- Benefit-risk evaluation, safety risk management and execution
- Signal detection
- RMPs/REMS
- Responding to safety-related queries from internal and external sources
- Responding to HA Assessment reports
- Ad-hoc reports
- Review of clinical protocols and study reports
- Review of safety sections of IBs and Regulatory Authority submissions
- Preparation, maintenance and review of DCSIs, CCSIs, USPIs and SmPC
- Presentations to Global Drug Safety and Labeling Committees and Health Authorities
Literature
We recognize that scientific and medical literature is an important source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues. Literature search and review is therefore a critical activity that we undertake for the safety profiling of drugs.
Vin-Wal has extensive capabilities for this activity and highlights of the service include:
- End-to-end literature services for ICSRs, PSURs, DSURs, signal detection and ad-hoc reports
- Search strategies
- Literature Search (EMBASE, PubMed, MEDLINE and non-indexed journals)
- Review of abstracts and articles
- Quality Review on sample of screened abstracts, articles and processed ICSRs
- Article Ordering
- Safety signals detection and analyzes
- Summarization of literature articles with MAH comments
- Literature management tools (QUOSA, Pi2, Reference Manager, pvPub, Infotrieve, DataStar)
