Product information in life sciences: 5 things you should know

    How can richer, more holistic product information – compiled in response to regulatory requirements – help transform life sciences business outcomes?

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    In the consumer world, smartphone apps are transforming people’s visibility, into their consumption habits for example, helping them to make better choices. Now the same needs to happen in life sciences, based on more unified product and regulatory status insights.

    In the 2020s, breaking down walls, consolidating disparate applications, and behaving more cohesively as a unified global business with end-to-end operational visibility, is a commercial imperative. Whatever the short- and longer-term fallout of Covid-19, organizations will need to come back fighting – with new tools at their disposal, ready to raise their game.

    Below are five strategic areas where life sciences organizations could transform decision-making, supported by holistic insights.

    1. Identifying ‘white space’

    Without an end-to-end line of sight across all international operations, and the ability to compare, analyze and probe back into historical trends, strategic teams will be limited in their ability to maximize revenues globally. Although it might be expected that sales teams would have this kind of visibility, this is often not the case where there are complex distribution networks in place – making it hard to understand where products actually end up and who is using them.

    The extent of companies’ lack of visibility has been exposed in recent years as companies have started to capture, consolidate and clean up product data in preparation for compliance with ISO IDMP and other regulatory/market transparency initiatives. Discovering where brands or particular SKUs are or aren’t present has been a revelation for more than one major player.

    2. Ensuring global regulatory & safety compliance

    Having visibility across global operations is only as valuable as the action companies are able to take on the back of those insights. If a substance or manufacturing change necessitates edits to registered information, and/or to safety instructions included on a product’s packaging and labeling, companies need the assurance that these changes are being rolled out globally with efficiency, accuracy and speed - keeping the company compliant and ensuring patients stay safe.

    With a unified information and content management capability, built on data assets of consistent quality and integrity, life sciences organizations will be better able to see that the last few times a change was required, it took a long time for updates to happen in Argentina or in South Africa.

    Spotting this kind of anomaly, corporate teams can begin to drill down into why that might be, and what extra support or amended workflow is needed to shorten future lead times.

    3. Accuracy of affiliate data

    Outlying operations may still use manual processes and spreadsheets to document and keep track of regulatory actions and outcomes locally. If details are not reported back to head office, companies will be compromised in their ability to produce and ships goods and labels to that market in a timely fashion. This in turn will have a detrimental effect on stock levels and revenue.

    Enabling affiliates to submit accurate data directly via a unified global system as developments happen, rather than relying on after-the-event reporting to HQ, will enable more effective planning.

    4. Smarter planning

    Once corporate HQ has a direct line to products’ registration status all across the world, teams can start to plan submissions and product maintenance/updates activity in smarter and more effective ways, building in contingencies where historically there have been issues.

    Project tracking, comparative analyzes of historical registrations, and the ability to predict outcomes of approval cycles in particular markets, can inform resource management, clinical trials activity, and more.

    As companies become more confident in the value of global data, the ability to link approvals to sales performance more directly, among other cross-analyzes, begins to look attractive too.

    5. Regulatory intelligence

    With precise regulatory requirements still varying between markets, life sciences companies need the ability to keep track of evolving requirements in each location.

    A platform designed to manage regulated content and processes and publishing, on a unified, end-to-end basis globally, should be able to incorporate these information feeds. As well as providing an at-a-glance understanding of which information requirements apply in each market, this intelligence could also cover respective expectations around specific safety studies. Desired studies might be linked to certain populations, or the potential for drug interactions if the target market has high use of a particular product – an anti-malaria treatment in African countries, for instance.

    The transformation imperative

    The ability to distill holistic new insights via business intelligence capabilities and dashboard displays, promises to be very powerful for life sciences companies. In the wake of Covid-19, companies’ future prospects are likely to depend on it.

    This article was originally published on PharmiWeb

    Published on    Last updated on 21/05/2020

    #Regulatory Information Management (RIM), #Life Sciences

    About the author

    With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience. As a Vice President for AMPLEXOR Life Sciences, David’s main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite to ensure that the solution meets the needs of the customer.

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