Step up with 4C's Pharmacovigilance Solutions

4C excels in providing end to end effective monitoring of safety and efficacy for Drugs, Devices, Biologics & Nutraceuticals. 4C is run and managed by medical doctors who have evolved from the Industry of  Clinical Research and Pharmacovigilance. We have handpicked best talent and trained them on robust 4C curriculum to deliver best in class service and experience to our Small, Medium and Large pharma clients. 

4C ADVANTAGE

4C excels in providing end to end effective monitoring of safety and efficacy for Drugs, Devices, Biologics & Nutraceuticals. 4C is run and managed by medical doctors who have evolved from the Industry of  Clinical Research and Pharmacovigilance. We have handpicked best talent and trained them on robust 4C curriculum to deliver best in class service and experience to our Small, Medium and Large pharma clients. 

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

Predefined Support

  • Aggregate Reports – DSURs, PSURs, PADERs, PBRERs
  • Signal Detection, Prioritization, Evaluation
  • Risk Management Plans (RMPs), REMS
  • Labelling Updates

Adhoc Support

  • Medical Monitoring
  • Risk-Benefit Assessment
  • Regulatory Authority Requests
  • Audit/ Inspection readiness, Mock-Audits

Argus hosting Support

  • Offers an integrated, highly scalable end-to-end safety platform
  • Models virtually any business process, supporting case
  • Provides comprehensive visibility into reporting metrics and compliance
  • Supports worldwide operations with single global database
  • Leverages a common code base and regular release schedule

Pharmacovigilance Services

  • Medical Information Call Centre
  • Follow up with reporters
  • Literature Search
  • In- House Argus  
  • Case Processing
  • Quality Check
  • Medical Review
  • Paper, SRP, ESG Submissions
  • PI/IRB Submissions
  • Periodic Reports
  • QPPV Support
  • Signal Management
  • Regulatory Intelligence
  • Risk Management
  • Data Quality Management
  • PMS and PASS
  • Reconciliation
  • Metrics Management

Pharmacovigilance Systems have been moving towards better environment and better reporting  platforms. This change was initiated by EMA which is preparing its systems to accept E2B(R3) reports from 22-Nov-2017.

4C Pharma Solutions is a comprehensive healthcare solutions provider company, specializing in Pharmacovigilance, Argus Hosting, Medical Information Call Center, Regulatory Affairs, Medical Writing and Hosting Solutions

15 Corporate Place South 
Suite 402 
Piscataway 
New Jersey 
USA. 08854  
Off: +1(732)529-6989     
Email: info@4cpharma.com