Beyond approval

How the right partnership simplifies complex pharmacovigilance

Collating information about adverse events, assessing their seriousness and causality, and meeting regulatory reporting obligations requires rigorous systems and subject specialists.

Partnering with an organisation to efficiently manage pharmacovigilance processes ensures your focus remains on commercialisation and your product remains safe and compliant.

Choosing a pharmacovigilance partner requires the same care that applies to protecting patient safety.

When assessing potential pharmacovigilance partners, seek one that provides the following end-to-end solutions:

– Collection and documentation of adverse events from sources including patients, healthcare professionals, literature and post-approval studies
– Triage and case prioritisation based on seriousness and potential risk to patient safety
– Assessment and causality evaluation that is thorough, accurate and consistent with known safety profiles
– Data entry and medical coding using standardised medical coding systems (MedDRA and WHO Drug Dictionary) to ensure consistent categorisation of adverse events and drug names
– Determining seriousness and regulatory reportability: assessing events as serious or non-serious in line with established criteria to ensure timely regulatory reporting and mitigate risks.

Additional considerations should include prior post-marketing pharmacovigilance experience, a global presence to support your product’s launch in new territories and around-the-clock support.

All of this must be done with the utmost commitment to accuracy, consistency and compliance.

Balancing the risks and rewards of automation

Many of the tasks associated with post-marketing pharmacovigilance are repetitive and time consuming.

Technology and automation have the potential to increase efficiency and reduce costs.

However, with such high stakes, drug and medical device developers are understandably extremely cautious in adopting new technologies, no matter how promising they seem.

Some organisations may be able to develop in-house automation tools, while others are hesitant to adopt these.

Failing to explore the possibilities offered by new technologies has a cost in terms of missed opportunities and potential time and money savings.

Capitalising on the benefits of automation while minimising risks requires working with a partner with a keen understanding of pharmaceutical industry-specific needs.

A pharmacovigilance partner that ticks every box

ICON’s post-marketing pharmacovigilance team supports pharmaceutical, biotech and medical device organisations of all sizes and across all therapeutic areas.

With a global team of more than 1,000 pharmacovigilance professionals, ICON can provide 24/7 support for pharmacovigilance.

Automation, machine learning and generative AI tools are judiciously deployed only where they deliver the most value, with an acute awareness of possible impact on patient safety and regulatory compliance.

Our technology has significantly reduced outsourcing costs without compromising accuracy and most of our solutions are system agnostic for easier collaboration with existing systems.

Crucially, our use of automation and AI is always overseen by experienced pharmacovigilance professionals and underpinned by powerful cybersecurity systems.

Services can be delivered as standalone, full service, consulting, FSP or blended.