Increasing compliance and efficiency
Navigating and Interpreting Evolving Regulatory Environment
The complex nature of regulatory safety reporting requirements demands a high level of expertise to ensure instant access to critical intelligence.
Global review capability to ensure compliance with mandatory regulatory safety reporting
Monitoring the regulatory landscape and assessing the impact of changes to ensure readiness for any wider cross-functional updates
Dedicated, multilingual, pharmacovigilance intelligence team specialise in the evaluation of safety reporting requirements through daily review of information from
- Contracted database
- Legal regulations and guidelines
- Authority web pages
- Direct established contact with regulatory bodies
Automation - Applied Innovation
Using regulatory intelligence gathered from 80 countries, the drug safety reporting system is configured with date-stamped decision rules. This facilitates the required safety information to be submitted and distributed automatically to all relevant stakeholders including sites, Ethic Committees, Institutional Review Board and Competent Authorities within due dates. The safety information is submitted in the mandated format in each case and a fully auditable distribution trail is provided.
The solution is developed on an innovative cloud-based system with automated and configurable business rules. It features reporting functionality and a dashboard showing both individual and aggregate submissions at a study and portfolio level. This provides you with increased transparency to monitor and manage developments and visibility into the safety profile of an investigational product throughout its lifecycle.
Increasing Compliance, Decreasing Site Burden
The result is higher quality, increased speed and stronger regulatory compliance. In addition, compound level reporting removes duplication of notifications to those sites participating in multiple studies investigating the same compound, thereby reducing investigator burden.