Running a global trial requires careful consideration of the relevant regional and national legal requirements for safety reporting. Over- or under-reporting in pharmacovigilance can affect patient safety, and poor regulatory compliance can result in warning letters from authorities, site inspections and financial penalties. It is critical to have clearly defined procedures for the collation of regulatory intelligence to ensure compliance.

ICON’s Safety Reporting Solution combines pharmacovigilance expertise and dedicated regulatory intelligence with innovative technology to protect patient safety, maintain compliance and decrease costs

The complex nature of regulatory and legal safety reporting requirements demands a high level of expertise to ensure instant access to critical and ever-changing intelligence. Our dedicated regulatory intelligence team deciphers legal requirements and pre-programmes clearly defined reporting rules into our Safety Reporting System, ensuring that the intelligence is updated on a real time basis. We cover over 100 countries for Competent Authorities (CAs), Ethics Committees (ECs), Investigational Review Boards (IRBs) and Principal Investigators (PIs) with date-stamped decision rules, as well as maintenance of safety intelligence for over 800 local ECs or IRBs.

Our team was established over a decade ago and has strong contacts within the global regulator groups to provide additional support where there are gaps in legislation or unclear legal requirements.

We also constantly monitor the global regulatory landscape to ensure we can quickly implement any cross-functional updates to prevent delays.

Our multilingual safety specialists are located across the globe and are available for at least 22 hours per day. They are dedicated to supporting submissions and providing study-specific information to ensure compliance. We assign a dedicated and experienced project lead as a single point of contact across the portfolio to provide business continuity.

The fully validated, FDA 21 CFR part 11 compliant ICON Safety Reporting system is developed on an innovative cloud-based system, featuring automated and configurable business rules for compliant, efficient and expedited periodic reporting to CAs, ECs, IRBs and PIs at a compound level.

The system ensures compliance with global mandated submission requirements and a fully auditable distribution trail, enabling the client to gain visibility into the safety profile of a product throughout its lifecycle.

Automation is only as good as its ability to exchange data with the source through integration with other clinical trial systems. We ensure our automation is underpinned by regulatory intelligence embedded within the pharmacovigilance system and is dynamic enough to cope with rapid change. Our system enables real time updates to site and study personnel along with automated filing of submission documentation in the eTMF system. This intelligent automation leads to 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 and the cost of administration.

Where E2B submissions are globally accepted, we deploy the Oracle ARGUS Safety Database as part of the ICON Safety Reporting Solution, enabling us to configure a dedicated schematic for each client. The system is FDA 21 CFR part 11 compliant and has the capacity to generate all standard regulatory and periodic reports.

This database is also E2B (R3) compliant and therefore able to support safety submissions and country-specific requirements, as more countries make safety submissions mandatory.

The ICON Safety Reporting System can be used with our safety database or as a standalone system.

Simultaneous compliance tracking within the ICON Safety Reporting System and integrated root cause analysis enables oversight by drug safety experts. Dedicated compliance managers analyse the data from the reporting system to identify trends and risk mitigation opportunities in real time.

The Safety Reporting System generates a monthly compliance report on individual submissions and aggregates reports over time and across study portfolios. This robust reporting provides increased transparency to monitor and manage drug safety, all in one place.