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Tailored pharmacovigilance solutions for biotech and small to mid-sized companies

Our tailored, flexible, and scalable pharmacovigilance solutions empower biotech and small to mid-sized companies to manage their pharmacovigilance obligations with the same efficiency and quality as larger firms, all while ensuring cost-effectiveness.

 

At ICON, we take pride in serving biotech and small to medium-sized pharmaceutical companies, which constitute 75% of our pharmacovigilance client base. Our comprehensive drug safety and pharmacovigilance solutions leverage our extensive expertise and experience, providing compliant, tailored, scalable, and innovative services. 

Flexible service models

We provide a variety of safety resourcing options, including unit-based, full-time equivalent (FTE)-based, and Embedded Solutions™ staffing models, allowing you to pay only for what you need.

Scalable solutions

Whether you are a startup with a single product or a mid-sized company with a growing portfolio, our solutions can adapt to your evolving demands.

Cost-effective services

Our high-quality pharmacovigilance solutions are supported by teams located in cost-efficient regions, ensuring you receive maximum value while effectively managing your budget without compromising quality.

A trusted pharmacovigilance partner

With over 25 years of experience supporting biotech clients, ICON’s pharmacovigilance team provides advice and support from pre-clinical safety through commercialisation. We prioritise transparency and are dedicated to ensuring patient safety and adherence to global and local regulatory standards throughout the product lifecycle, from early development to late-stage and post-marketing.

Our cross-functional experts understand the challenges of clinical development and create customised solutions to meet evolving needs. We strive to be a true partner to our biotechnology clients, integrating seamlessly as an extension of their development teams. 

We adhere to four key principles, ensuring that we grow alongside our clients, delivering the support you need at every stage of your journey.

  • Tailored pharmacovigilance approach

  • Value-driven case processing

  • Quality oversight

  • Expert consulting

We offer a comprehensive range of services, including:

  • Data migration and safety database hosting
  • Case processing and reporting in over 100 countries
  • Regulatory intelligence consulting
  • Specialised pharmacovigilance support, including signal detection, literature surveillance, aggregate report generation, and risk management planning
  • Pharmacovigilance quality system support and gap analysis
  • Consulting on required pharmacovigilance activities for marketing authorization and commercialisation strategies
  • Full post-marketing support, including medical information call center services, PSMF generation, and QPPV and LPPV services

Safety surveillance during clinical trials and beyond

Safety surveillance is essential throughout the drug development lifecycle, encompassing both clinical trials and post-marketing phases. To establish the safety profile of an investigational medicinal product or an approved product, it is essential to detect safety concerns early, conduct comprehensive benefit-risk assessments, and determine the necessity for additional activities, studies, and risk minimisation measures.

For biotech and small to mid-sized pharmaceutical companies, partnering with ICON provides access to specialised safety expertise and advanced tools, such as SIGNET, which can streamline safety monitoring, enhance data analysis, and support regulatory compliance without the need for substantial internal resources.

SIGNET is ICON’s advanced signal detection and visualisation tool, used to analyse aggregate safety data during clinical trials and post-marketing, allowing for the prompt identification of safety issues. Regular review of aggregate safety data is integral to proactive drug safety management throughout the product lifecycle, and implementing well-defined processes for evaluating safety data is crucial for ensuring patient safety.

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