Pharmacovigilance Solution

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

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

Contact us to day to find to out how you can benefit from this unique solution.

 

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