The Global Safety and Pharmacovigilance team at Technical Resources International, Inc. (TRI) provides vision, leadership, strategic planning, budgeting and oversight to the execution of clinical operations in multiple therapeutic areas, including Oncology, Cardiology, Ophthalmology, Dermatology, and Infectious Diseases for our clients. TRI offers individual safety monitoring services as well as a turn-key Safety Monitoring Program.
Key Services
- Pharmacovigilance
- Risk Evaluation and Mitigation Strategies (REMS) and protocol-specific Pharmacovigilance Plans
- Data mining and safety data analysis
- Signal detection and signal evaluation reports
- Safety alerts and safety distributions
- Company core data sheets
- Investigator’s Brochures
- Package Inserts
- Adverse events expectedness lists
- Risk-related position papers
- Literature reviews and summaries
- Drug safety gap analysis
- Regulatory Reporting
- AE/SAE evaluation, narratives, physician review
- Generation of MedWatch 3500A/CIOMS I Forms
- Timely regulatory submissions
- Aggregate reporting per FDA Final Rule requirements
- Safety Monitoring Committee/DSMB Management
- Periodic Safety Update Reports (PSURs)
- Development Safety Update Reports (DSURs) and Annual Reports
- Dictionary Management
- MedDRA coding, upversioning, uncodable AE terms review, and MSSO submissions
- CTCAE coding
- SOPs and report templates
- Training
- eLearning, webinar, and face-to-face formats
- AE/SAE reporting
- Pharmacovigilance
- MedDRA coding
- Medical monitoring
- Signal detection
Our Safety and Pharmacovigilance team can act as your Subject Matter Expert helping you navigate the challenging international regulatory safety requirements for your pre- and post-marketed medicinal products.
Our team is staffed with highly qualified medical professionals (licensed MDs, RNs, PharmDs, and PhDs) who are well versed in safety reporting regulations. Over the last 5 years, our high throughput process allowed us to flawlessly receive and review more than 25,000 SAE reports from more than 4500 protocols and 3800 sites. TRI’s Global Safety and Pharmacovigilance team is a key member of the National Institutes of Health MedDRA Working Group.
