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We deliver end to end of Pharmacovigilance Solutions

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Pharmacovigilance Solutions

Global & Local Literature Search

Case Processing

Electronic Submissions

Periodic Reports

Signal Detection

Risk Management

Medical Monitoring

Database Management

QPPV Support

Pharmacovigilance
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
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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
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