Big data provided by devices and apps has led to a wave of new insights into consumer and business behaviors. Can the same approach help life sciences companies identify opportunities to market products, meet compliance and optimize submission planning?
Traditional methods of managing regulatory information and processes within global life sciences companies have changed little over the years. Core data sheets and safety information are set down centrally, and it is then left up to each regional affiliate to do what is required to get a product approved in the local market.
At the same time, major submissions are handled on the corporate level (HQ) and then sent to affiliates, where each local organization prepares and submits what is required locally. However, this information is rarely provided back to corporate HQ. As a result, in many instances, global HQs have minimal insight of what has been submitted and what follows in the interim. This not only hinders the brand’s compliance position, but also the understanding of how organizations are performing in distant markets and what it would take to improve success.
Unifying regulatory information management (RIM) across the global organization, including regional affiliates, can be the answer to this problem. RIM creates a clear line of sight across all current product registrations and market authorization and submission activity.
Breaking down walls, consolidating disparate applications, and behaving more cohesively as a unified global business with end-to-end operational visibility, is crucial for your success.
In a new series of blogs, we will discuss five strategic areas that can be empowered by rich new insights - enabled by a unified global RIM capability, to transform decision making and operational processes.
As long as corporate HQs continue to hand off regulatory and safety information to subsidiaries and local affiliates without any link back to HQ, strategic decision makers have no clear visibility of their product registrations across the globe and where there may be untapped opportunities. It could be that certain variants of a product are not yet licensed in a particular territory, or that approval of a marketing authorization submission has been held up; or that a whole category of product is missing from a market - for reasons not known to head office.
Central teams can only take action based on the information available to them. Without an end-to-end line of sight across all global 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 challenging to understand where products end up and who is actually 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 in global life sciences.
By introducing visibility and clarity across the business, companies can begin to close the gap and eliminate the white space.
In our next blog, we’ll look at the next strategic area that's ripe for transformation: global regulatory and safety compliance, enabled by globally unified data.
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.