Affiliate Level Solution | Pharmacovigilance

Flexible, compliant and cost effective

Due to harmonisation of pharmacovigilance (PV) regulations and globalisation, the role of an affiliate has shifted to be a dual role - driving commercial growth along with pharmacovigilance management. The operations associated with regulatory and pharmacovigilance activities have become an unwanted burden and yet now more than ever pharmacovigilance is complex.

We deliver an efficient and regulatory compliant solution whilst retaining the effectiveness of a local presence. A centrally managed, geographically dispersed solution leverages our expertise and technology infrastructure. This flexible outsourced solution means you get the skilled resources when you need them and maintain the essential oversight into what is happening locally.

ICON has a proven record (see Case Study below) in delivering projects within the affiliate model across Asia, Pacific, Europe, North and South America, Middle East and Africa along with over 99% compliance in ICSRs submissions.

Benefits

Reduces time

A global scalable infrastructure enables flexible, dynamic and fast roll-out of PV services across all countries
From many vendors to just one - means that you have to spend less time auditing multiple vendors

Increases quality and compliance

PV expertise and consistent integrated workflows ensure regulatory compliance
Full transparency and oversight into country and global performance metrics to ensure compliance
Quality Management and continuous improvement in place

Increases cost efficiency

Streamlined processes to achieve operational excellence and maximise time and cost efficiency
Eliminates the need to hire new resources in countries where currently no direct sponsor representation

Whitepaper: Affliliate level solution

This whitepaper explores the benefits in adopting an outsourced model for pharmacovigilance that is centrally managed and geographically dispersed, ensuring efficient and compliant delivery whilst retaining the effectiveness of a local presence.

Global foot print and range of available services

Global Infrastructure

Specialised and well structured procedures, processes, technology and local relationships in place
Over 80 countries across the globe, including emerging markets
Technology infrastructure available if required by client

Expertise and Experience

Professional experienced team with a proven record in delivering projects within the affiliate model and FSP model
Services includes support from QA, Legal and Procurement.

Full range of services

Clinical Trials
Post Marketing
Medical Devices
In vitro Diagnostics
LPPV requirements

Case study

Learn how one client streamlined global oversight and processes with this solution

Flexible, compliant and cost effective

Benefits

Whitepaper: Affliliate level solution

Global foot print and range of available services

Case study

In this section

Connect with us

Pharmacovigilance Solution

Flexible, compliant and cost effective

Benefits

Whitepaper: Affliliate level solution

Global foot print and range of available services

Case study

In this section

Connect with us

Ensuring pharmacovigilance compliance and robust oversight at the affiliate level

The impact of COVID-19 on pharmacovigilance

Pharmacovigilance - Protecting Patient Safety throughout the Drug Lifecycle

ICON Pharmacovigilance Solutions

Overhaul of Pharmacovigilance in the EEA

New EudraVigilance System