InClin offers customized Drug Safety solutions to match your needs while maintaining the highest internal standards to meet regulatory obligations. We provide Drug Safety oversight at every step including intake, evaluation, processing, site interaction, and regulatory reporting. Additionally, InClin offers the Argus database platform, a fully qualified and validated system, for your pharmacovigilance and drug safety needs.
Drug Safety and Pharmacovigilance is much more than case processing. We can structure our services to suit your needs. Whether you have a Phase 1 or 4 study, or whether you are looking for a stand-alone service or a full-service package, we can customize a solution that works for you.
DRUG SAFETY AND PHARMACOVIGILANCE SERVICES:
- Argus Database Implementation – Fully qualified, validated Argus database for serious adverse event intake, evaluation, and reporting. Available to function independently to support for studies conducted by the sponsor or other sponsor collaborators
- Safety Case Processing and Reporting – Optimized Drug Safety data collection and processing to make the steps efficient, seamless, accurate, and responsive to client needs
- Risk Management and Assessment – Continuous monitoring and assessment is critical to the establishment of an accurate safety profile
- Pharmacovigilance and Drug Safety Auditing – Experienced auditors providing safety assessments and auditing to determine compliance with regulatory requirements and inspection readiness
- Regulatory Reports– Preparation and evaluation of aggregate safety data insuring regulatory compliance. Includes DSUR, IND annual reports and Clinical Study Reports
- Training – InClin Drug Safety and Pharmacovigilance team provides training and support to all team members through Investigator Meeting presentations, SIVs, client team meetings, and additional training as requested