Pharmacovigilance Support and Consultancy
Maintaining the safety data of medicinal products/medical devices and reporting of safety information to regulatory authorities is mandatory for Marketing Authorization Holders (MAH) throughout their use in healthcare practice. Therefore each MAH requires to operate pharmacovigilance system.
There are multiple steps involved in pharmacovigilance process including case intake, case triage, data entry, case processing, quality review, medical review, preparation of summaries and submission to regulatory authorities as Individual Case safety Reports (ICSR). The safety data is then compiled and evaluated as a part of aggregate reports in the form of periodic safety reports, benefit-risk evaluation, signal management and risk management.
EPharmaceuticals offers end to end pharmacovigilance services to ensure pharmaceutical developers meet regulatory requirements. Our PV team is comprised of physicians, pharmacists and other healthcare professionals who expertise in handling activities for setup and management of effective and efficient pharmacovigilance system.
What We do
Pharmacovigilance Processes
- Setup and implementation of Pharmacovigilance system, including preparation/maintenance of Pharmacovigilance System
- Master File (PSMF), preparation and maintenance of SOPs.
- Pharmacovigilance consultancy and Project management
Case Management and ICSR Processing
- Case intake and Triaging
- Data entry
- Coding of products
- Coding of events and other medical
- information using MedDRA
- Writing narratives
- Causality Assessment
- Labelling Assessment
- Quality review
- Medical Reviews
- Expedited reporting cases to Authorities
- Electronic reporting and reconciliation
- Case Follow-up activities
- The company is experienced in data entry for ARGUS.
Literature Searching Services
- Epharmaceuticals offer weekly reviews of reference databases using PubMed or routine in-house investigations. We also document all the safety findings that have been identified and reported in preparation for periodic reports and signal detection,
Aggregate Reporting
- Developmental Safety update reports (DSUR)
- Periodic Safety Update Reports (PSUR)
- Periodic benefit-risk assessment reports (PBRER)
- Periodic Adverse Drug Experience Reports (PADER)
- Risk Manamegement Plans (RMPs)
- Risk Evaluation and mitigation plans (REMP)
- Safety Assessment Reports (SARs)
- Safety Narratives
- Annual Safety Reports (ASRs)
Signal Management
- EPharmaceuticals offers the creation of signal detection reports from safety database and evaluation of any new or ongoing signal which impact benefit-risk profile.
GET IN TOUCH NOW
For more information on our expert clinical operations services, call us at (410) 928-8187 to speak to one of our knowledgeable team.