Affiliate level solution

A mid-size pharmaceutical company with numerous affiliates and local vendors across 80 countries sought a reliable partner for effective Pharmacovigilance (PV) and Medical Information (MI) services. The company's consolidated PV operations were provided by local vendors and affiliates, creating significant challenges in consistency, oversight, and compliance. 

The burden on sponsor resources to ensure effective management and alignment across these affiliates and vendors was immense, leading to:

• Overwhelming responsibility to provide consistent oversight
• A lack of oversight and consistency
• Variable global compliance 

ICON implemented a comprehensive PV affiliate level solution for a streamlined and harmonised approach to PV and MI services

Global case processing

ICON centralised and streamlined case processing for adverse events, ensuring that all data was accurately captured and compliant with regulatory standards.

Medical information services

The team provided medical information management, offering expert, consistent responses to inquiries across all regions

Local literature searches

Localised search activities were standardized to ensure thorough and compliant medical literature reviews.

Local QPPV services

ICON provided Qualified Person for Pharmacovigilance (QPPV) services at the local level, ensuring full compliance with country-specific regulatory requirements.

The transition to ICON’s Pharmacovigilance and Medical Information Affiliate Model led to a significant improvement in operational performance and regulatory compliance for the sponsor.

ICSR compliance improvement from less than 90% prior to ICON’s involvement to over 99% post-implementation.

Improved oversight: The client gained enhanced visibility and control over its global PV and MI activities, enabling them to report ongoing performance and compliance metrics effectively.

Process harmonisation: ICON implemented consistent and standardised processes across all regions, significantly reducing regional variations and improving communication between teams.

KPI targets: ICON consistently exceeded Key Performance Indicators (KPIs) related to case processing times, response accuracy, and overall efficiency.

Client satisfaction: The client expressed high levels of satisfaction, citing improved operational efficiency and regulatory compliance as key benefits.

Cost reduction: By streamlining operations and eliminating inefficiencies, the client experienced over 20% reduction in operational costs.

To more information on how ICON’s pharmacovigilance expertise can streamline complex global operations and drive better compliance and outcomes, visit ICONplc.com/pv.