CLINICAL TRIALS SAFETY
The monitoring of serious adverse events (SAEs) is critical. The early detection of adverse event trends or potential signals in development can save time, money, and most importantly, lives. When assessing compounds, it is critical to have concise, detailed initial and follow-up information that includes: relevant patient and medication history, accurate coding, and medical assessments by qualified healthcare professionals for each serious adverse event report.

DSA provides comprehensive clinical case management support by:

• Intake of serious adverse event data (SAEs and SUSARs)
• Triage and tracking all cases utilizing DSA’s proprietary CMT™ system
• Initial and final regulatory assessments
• Completing timely medical review and writing
• Data entry into 21 CFR, Part 11 compliant database
• Relevant site and investigator queries and follow-up
• Accurate MedDRA and WHO-drug coding
• Development and maintenance of the Analysis of Similar Events (AOSE)
• Complete Medical Monitoring support
• Seamless notification of all investigators, regulators, client and other contractual partners
• Streamlined, cost-effective legacy case management

DSA can build and maintain your product’s global safety database thereby ensuring regulatory time lines and obligations are met.

Many safety issues arise after products are in wide-spread use throughout the world, This is why working with safety experts is critical. DSA can provide full case management support or augment existing internal safety departments to ensure your pharmacovigilance program is robust and complies with all regulations (domestic or abroad).

Contact us to learn more about out services.