InClin offers customized Clinical Drug Safety monitoring solutions, for evaluation, processing, site interaction, and regulatory reporting crucial to study success. We are dedicated to maintaining the highest standards for data integrity to meet regulatory guidelines and obligations following study-proven management processes facilitated by a highly skilled and experienced safety team.
Risk Mitigation and solution-oriented oversight utilizing standardized processes, including the industry leading Argus Safety database, to effectively meet the increasingly complex global regulatory requirements to assess, analyze, and evaluate clinical adverse event data to ensure patient safety while maintaining data compliance and security.
Clinical Drug Safety is more than case processing. Our USA-based service is locally processed but globally accessible. Our goal is to make Drug Safety and
Pharmacovigilance Efficient, Responsive, Accurate and Seamless (ERAS).
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