Piscataway, NJ, USA -08854
Top Pharmacovigilance Solutions Provider Company
We deliver end to end of Pharmacovigilance Solutions
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Global & Local Literature Search
Case Processing
Electronic Submissions
Periodic Reports
Signal Detection
Risk Management
Medical Monitoring
Database Management
QPPV Support
Adverse Event Reporting Systems
These systems capture and analyze data related to adverse events associated with drugs.
Risk Management Plans
These plans outline strategies to minimize the risks associated with drugs.
Data Mining and Analysis
This involves the use of advanced data analysis techniques to identify potential safety issues.
Signal Detection and Management
This process involves analyzing data to detect potential safety signals and then managing those signals to determine if further action is necessary.
Post-Marketing Surveillance
This involves monitoring the safety of drugs once they are on the market.
Pharmacovigilance Training and Education
Providing training and education to healthcare professionals
Ongoing Support
- Safety Development Plan – SOP writing, Data
Migration, Implementation, Training - Case intake and Monitoring – Call centre
activities for AEs, PQCs and MI, Validity,
Duplicate check, Reportability, Triage - AE/ SAE/ processing – Data Entry, Coding,
Narrative Writing, Validation, Medical
Review, Submission, Follow-up, Compliance - Literature Search & Insights
Pre-defined Support
- Aggregate Reports – DSURs, PSURs, PADERs,
PBRERs - Signal detection, prioritization, evaluation
- Risk Management Plans (RMPs), REMS
- Social Media Analytics for PMS and
Spontaneous Adverse Events
Adhoc Support
- Medical Monitoring
- Risk-Benefit Assessment
- Regulatory Authority Requests, Audit/
Inspection readiness, mock-audits - Health Care Analytics
- Research Analytics and Insights
