Step up with 4C's Pharmacovigilance Outsourcing Solutions
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 or Pharmacovigilance (PV) Outsourcing. 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 Outsourcing 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.
15 Corporate Place South
Suite 110
Piscataway, New Jersey 08854
USA
Phone: +1 (732) 529-6989
Fax: +1 (732) 529-6990
Email: info[at]4cpharma.com