Keeping It Compliant

By Suzanna Gamwell

Keeping It Compliant

‘It’s fantastic! But is it compliant?’ A question we are often asked when explaining how CREATION Pinpoint can help our clients study conversations between their Healthcare Professional (HCP) customers on public social media.

The answer, of course, is a resounding ‘yes’. At CREATION, we are not only serious about compliant research; you could say we are passionate about it.

Since CREATION was established in 1998 we have pioneered online behaviour analysis, and as such have never been far from conversations about pharmacovigilance, adverse event reporting, and compliance.

Over the years, we have led industry conversation around compliant online research: publishing a global study of reportable mentions on social media; working with PIPA (Pharmaceutical Information and Pharmacovigilance Association) and speaking at their conferences; working with MHRA (Medicines and Healthcare products Regulatory Agency) to identify and mitigate social media risks; and acting as expert advisors in client representation to ABPI (Association for the British Pharmaceutical Industry) on adverse event reporting, which has helped to inform ABPI’s social media guidelines. In the US market, we actively analysed and commentated on the FDA’s (Food and Drug Administration) 2015 social media guidance for drugmakers.

As specialists in what HCPs are saying on public social media, we see that volumes of specific product mentions by HCPs are generally low. Our studies have shown that HCPs are more likely to talk about a therapy area or class of drugs, rather than named products. However, even a small volume of product mentions creates the potential for a reportable event within a study, and this being the case, we have robust internal processes in place to complement the reporting requirements of our clients. Our analyst and client facing teams are BHBIA AE accredited, complete additional pharmacovigilance training with our clients’ drug safety teams, and use our in-house, auditable system for recording reportable events.

Why do we take compliance so seriously? Firstly, because it is a major consideration for our customers when commissioning a study. Knowing that our team understands the highly regulated pharmaceutical and healthcare environment, undertakes regular pharmacovigilance training, and can work effectively with drug safety teams, gives assurance to clients that they can commission great research without creating unnecessary risk.

However, looking beyond risk management, pharmacovigilance exists to improve patient safety and drug efficacy. Proactively detecting reportable events across a range of indicators contributes to product information staying current and accurate, meaning that patients and HCPs can make informed decisions around treatment. We know that our compliant studies are part of a much wider global pharmacovigilance effort, that isn’t just about ticking a box; it’s about contributing to an ongoing dialogue that, ultimately, protects and improves the lives of patients.

For more information on pharmacovigilance download our free Whitepaper on Pharmacovigilance in HCP social media listening.

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Meet the Author

Suzanna Gamwell