Medfiles USA is committed to ensuring the health and well-being of patients and consumers and to collaborating with clients to meet the increasingly complex regulatory requirements within the global pharmacovigilance landscape.
Our full range of services include end-to-end case processing, efficient management, effective governance and continuous process improvement from early stage clinical development to marketed product support. Through skillful metrics management, dashboard reporting, quality compliance and adherence to regulations and customer needs, Medfiles USA creates value across the entire spectrum of pharmacovigilance and risk management.
Our team is comprised of highly trained professionals and physicians who bring years of experience from within the company, various CROs and the pharmaceutical industry.
Medfiles USA Service Items:
- Multilingual individual case safety report (ICSR) processing
- MedDRA coding
- Narrative writing
- Global expedited case reporting and management
- PV consultancy and project management
- Global periodic safety reporting (PADER, PSUR/PBRER)
- Provide support for ASR/DSUR
- Provide medical review support
- NDA and IND submissions (supporting preparation of IND/NDA annual reports, NDA ISS sections and clinical study reports)
- Addendum reports
- Summary bridging reports (SBRs)
- Drug safety reports (DSRs)
- Development safety update reports (DSURs)
- Annual safety reports (ASRs)
- Assessment strategy-routine and/or proactive data mining for signals
- Screening, identifying, prioritizing, analyzing, evaluating and reporting
- Medical event surveillance and monitoring
- Signal event analysis
- Tracking and trending of safety signals based on intervals
- Comparative and statistical analysis based on external reporting databases (AERS and WHO VigiBase)
- Evaluation of potential signals from aggregate analysis
- Formal analysis report generation
Medical Call Center
We have a dedicated medical information call center staffed with an extensive team of medical professionals, including nurses, pharmacists and PharmD-qualified health care experts.
- Centers are LIVE 24/7/365
- Multilingual support
- Compliant with HIPAA and other applicable local and global regulations
- Real-time trained professionals
- Industries supported include hospitals; biopharmaceutical, cosmetic and medical device companies; and consumer companies
- Information handled: medical information, adverse events, product quality complaints, inquiries, reimbursements, counterfeit product information, etc.