Clinical Research Capabilities
Clinical expertise is the foundation of our business. Norwich staff have been conducting clinical studies for more than 20 years, including 2,000+ biostudies that have resulted in successful regulatory submissions to FDA, EMA and numerous local agencies.
- Multiple hospital-based clinic locations
- Pharmacokinetics studies in healthy volunteers
- Drug metabolism studies
- Dose proportionality studies
- Multiple dose studies
- Experience in multiple dosage forms
Bioanalytical and Laboratory Services
Norwich Clinical Services provides quantitative measurements of active drug and/or metabolite in biological matrices. Our method development team is committed to developing methods with the lowest LOQs and quick turnaround time.
- Method development and validation
- Sample analysis
- LC-MS/MS-API 4000 UPLC
- HPLC & LC-MS/MS analysis of drug and metabolites in biological fluids
Norwich Clinical Services offers comprehensive, low-cost pharmacovigilance services for pre-marketing product safety, post-marketing surveillance and data analysis.
- Signal detection analysis and risk mitigation programs
- Oracle AERS 24x7 call center monitoring
- FDA, EMA and CEE country submissions via eCTD utilizing eCentral
- Axway Synchrony Gateway for E2B exchange
- Large volume data migration capability
- Preparation of ICSRs and PSURs
- QPPV support
- PV database support
Norwich pharmacovigilance activities are conducted in compliance with the 2012 EU Pharmacovigiance Legislation and has completed numerous filings into the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).
All Norwich pharmacovigilance services are fully compliant with GCP, GLP and 21 CFR part 11.