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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Navigating compliance
Compliance is the leading concern for IM services executives, and they need industry experts to meet their needs.
Oct 23, 2020
If you are worried about regulatory compliance in information management (IM), you aren’t alone.
Our recent survey of life sciences IM services executives found that ‘compliance requirements’ was the most important issue influencing their decision to adopt any IM technology. Fully 60 percent ranked compliance requirements as one of the top two reasons they considered an outside solution, and for many smaller and mid-sized firms it was the single key driver for considering these investments.
It’s not surprising. The continuous evolution of regulations and increasing demand for data sharing is putting pressure on life sciences companies to deliver more robust compliance processes. This is piquing their interest in IM solutions that promise to streamline their compliance activities and regulatory reporting.
Experts only
The focus on compliance also sets the tone for their IM platform research, shaping what they look for in a vendor, and how they decide which solution will best meet their needs. The key for many decision makers in this space is choosing a vendor with deep ties and expertise in the life sciences industry.
Risk-averse life science leaders want a solution that will improve their ability to adhere to these rules, and to rapidly adapt when the rules change. To do that they need vendors who grew-up in this industry so they can trust. The survey found that 65 percent of respondents said vendor expertise was the top attribute they consider when vetting a partner followed by price.
This is an important distinction. While there are many IM technology vendors in the marketplace, most have their roots in technology rather than pharma. They build platforms with all the bells and whistles, then customize them for the unique needs of each industry. While these platforms are technologically sound, they weren’t built by industry experts, who have spent their careers navigating the complex and constantly changing regulatory environment of the global life sciences landscape.
Our industry regulations can change on a daily basis, and every country has its own versions of the rules, each of which comes with complicated compliance requirements. If a vendor doesn’t fully understand the complexities and dynamics of this environment, even small choices in a platform, like failing to include an opt-in field while collecting personal information, can put organizations at significant risk of violations. This is why it is so important to rely on vendors with a deep bench of both regulatory and technical talent, who can help them manage compliance issues to a level of detail that accommodates global trends.
Vetting vendors
When searching for an IM solution, companies should seek out vendors who have experts dedicated to monitoring global regulations, and who understand the implications these shifting rules have on platform dynamics and workflows. When regulations change, the platform should be flexible enough to adapt where necessary, ensuring users can avoid ‘failure to comply’ risks that could otherwise result in significant fines -- as much as four percent of revenue in cases related to GDPR compliance.
They should also look for proof of value. A good IM platform doesn’t just reduce the risk of fines. When companies deploy end-to-end IM solutions to create an integrated information management environment it generates efficiencies in the internal processes, improves data quality and increases the reliability of their data analysis. This makes it easier to generate regulatory reports, lessens the risk of missing or incomplete data, and can shorten the time to achieve or maintain product approval.
When companies take the time to find the right technology – and vendor partners – they can generate substantial business value from their IM solutions.