Clinical Drug Safety

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.

We deliver solution‑oriented safety oversight using standardized processes and the industry‑leading Argus Safety database. Our approach ensures accurate assessment, analysis, and evaluation of clinical adverse event data; helping you navigate complex global regulatory requirements while maintaining the highest standards of patient safety, 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).

THE INCLIN ADVANTAGE:

• Scientific/Medical Expertise — Trained scientists with an average of 25+ years of experience, skilled at evaluating, processing and reporting according to global regulatory requirements
• Comprehensive Experience — Our broad industry knowledge allows us to tailor our services to achieve each Sponsor’s specific goals
• Customized Solutions — We work with a wide range of companies, from regional to global corporations, who have diverse products and development needs
• Proven Quality Processes — We use validated systems and processes to provide drug safety clinical trial oversight and support at every step including intake, evaluation, processing, site interaction, and regulatory reporting.
• Collaborative Environment — We work as an integral part of the project team with the belief that we can achieve more together
• Resource Rich — We are flexible and can add resources for your studies and team, as needed, to ensure that timelines are met as your project evolves
• Availability – Providing rapid response to inquiries, our US-based team ensures availability to sponsors to support agile and well thought-out responses to inquiries and a hands-on approach delivering the positive experience that is a trademark of InClin.

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 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 ensuring regulatory compliance. Safety data for DSUR, IND annual reports, and Clinical Study
• 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

These reports are written by InClin Med Writing so be sure the information on both is complimentarty.