Pharmacovigilance Excellence

Cloud Based Pharmacovigilance Solution

Our Pharmacovigilance Solutions

Global & Local Literature Search

Case Processing

Electronic Submissions

Periodic Reports

Signal Detection

Risk Management

Medical Monitoring

Database Management

QPPV Support

We Strive to Serve Our Cause

“Passion for Patient Safety” reflects our unwavering commitment to ensuring the well-being and safety of every patient. It signifies our dedication to implementing rigorous pharmacovigilance practices, constantly monitoring and assessing the safety profile of pharmaceutical products.


Attributes of Our Pharmacovigilance Solutions

Adverse Event Reporting Systems

These systems capture and analyze data related to adverse events associated with drugs.

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.

Risk Management Plans

These plans outline strategies to minimize the risks associated with drugs.

Post-Marketing Surveillance

This involves monitoring the safety of drugs once they are on the market.

Data Mining and Analysis

This involves the use of advanced data analysis techniques to identify potential safety issues.

Pharmacovigilance Training and Education

Providing training and education to healthcare professionals

Why Choose Us

Ongoing Pharmacoviglance 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 Pharmacovigilance Support

  • Aggregate Reports – DSURs, PSURs, PADERs,
  •  Signal detection, prioritization, evaluation
  •  Risk Management Plans (RMPs), REMS
  •  Social Media Analytics for PMS and
    Spontaneous Adverse Events

Adhoc Pharmacovigilance Support

  • Medical Monitoring
  •  Risk-Benefit Assessment
  •  Regulatory Authority Requests, Audit/
    Inspection readiness, mock-audits
  •  Health Care Analytics
  •  Research Analytics and Insights

Our Pharmacovigilance curriculum is offered at Temple University, and we take pride in this accomplishment.

4C Pharma Solutions

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