Safety Reporting Group

ICON’s Safety Reporting Group ensures seamless compliance and efficient safety management for clinical trials, supported by advanced automation and global expertise.

The global regulatory landscape for safety reporting is complex and constantly evolving. Staying informed on changes is crucial, as non-compliance can lead to fines, product recalls, and legal liabilities. ICON’s Safety Reporting Group actively monitors these developments to ensure compliance and mitigate potential risks.

Comprehensive safety services

Our safety reporting services deliver efficient, reliable compliance support across the product lifecycle, including pre- and post-market activities for drugs, biologics, medical devices, and in-vitro diagnostics.

Regulatory expertise:

Guidance on global and local compliance requirements.
Impact assessments of regulatory changes and cross-functional change management.
Direct contact with worldwide regulatory authorities.

Global reach and support:

A regulatory intelligence database covering 100+ countries.
Multilingual teams in Europe, Asia, and Latin America providing 24/7 coverage and regional expertise.

Advanced automation and efficiency:

Robotic process automation for reliable, fully tracked regulatory submissions.
Streamlined retrieval and analysis of compliance documents.

Comprehensive safety management:

End-to-end regulatory reporting setup and maintenance.
Routine compliance updates, reporting, and consultancy.

Quality and transparency:

Robust QC processes and clear monthly submission metrics.

EudraVigilance expertise for the EEA Market

For products entering the European Economic Area (EEA), ICON provides specialist guidance on EMA registrations, EudraVigilance submissions, and XEVMPD. Our experts, trained directly by the EMA, regularly participate in EMA programs to stay updated on evolving regulatory standards.

ICON’s Safety Reporting Solution

Our cutting-edge solution combines pharmacovigilance expertise and dedicated regulatory intelligence with innovative technology to protect patient safety, maintain compliance and decrease costs.