{"id":76118,"date":"2024-02-29T00:03:07","date_gmt":"2024-02-28T23:03:07","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?p=76118"},"modified":"2024-02-29T12:48:06","modified_gmt":"2024-02-29T11:48:06","slug":"rewriting-the-business-case-for-regulatory-transformation","status":"publish","type":"post","link":"https:\/\/pantheon.veeva.com\/eu\/blog\/rewriting-the-business-case-for-regulatory-transformation\/","title":{"rendered":"Rewriting the Business Case for Regulatory Transformation"},"content":{"rendered":"<p>Regulatory teams making the case for digital transformation often encounter the same obstacle: they must persuade leadership to finance a long-term investment without visibility into potential regulatory changes, technology advancements, or company strategy.<\/p>\n<p>As Bayer and another top 20 biopharma company explain, a foundation in technology and data is a powerful enabler in a dynamic environment. But it is also just the beginning of the journey. To secure support for ongoing regulatory transformation, your business case needs to demonstrate both the immediate and long-term value that will be realized after implementation.<\/p>\n<h2>Traditional dimensions won\u2019t work<\/h2>\n<p>Regulatory transformation programs are often multi-year processes. As a result, it can take some time to build a robust business case, not least because fast-moving targets, a changing technology landscape, and <a href=\"\/eu\/resources\/solving-pharmas-regulatory-jigsaw-puzzle\/\">a dense regulatory agenda<\/a> are making it harder for biopharma companies to see around the corner.<\/p>\n<p>A successful business case will align with company strategy and answer the question: how will this investment support our broader mission? The aspiration could be to respond more nimbly to regulatory requirements, for example; or ensure more efficient ways of working across a global footprint. As one global head of regulatory operations at a large biopharma company notes, \u201cThe world is spinning faster every year\u2026 And focusing only on the traditional dimensions of efficiency, acceleration, and compliance won\u2019t give you a compelling business case.\u201d<\/p>\n<p>In our experience, the most effective teams anticipate that their investment must show value almost immediately and establish which key performance indicators (KPIs) will consistently provide the required data. Mark Davies Karvonen, global product manager at Bayer, notes: \u201cWe get asked about the value delivered by the program almost every week. We would like to prove it with data.\u201d<\/p>\n<p>Once the business objectives have been agreed upon, each of these can be mapped to associated benefits, value drivers, and KPIs that will be realized over time [Figure 1]. By defining how to realize value in your business case, you can start collecting data soon after signing off.<\/p>\n<p><strong>Figure 1: Defining the path to value realization<\/strong><\/p>\n<p><img decoding=\"async\" class=\"img-responsive mw-700\" alt=\"\" src=\"\/eu\/wp-content\/uploads\/2024\/02\/Path-to-measuring-value-defined-in-your-business-case.png\"><\/p>\n<p><em>Source: Veeva Business Consulting<\/em><\/p>\n<p>\u2003<\/p>\n<h2>Collecting data that counts<\/h2>\n<p>It\u2019s easier to start measuring once the wider business agrees on where it expects to realize the most value. Quantifiable KPIs should flow from the benefits and value drivers you have defined [Figure 2].<\/p>\n<p>Figure 2: KPIs should flow from value drivers and benefits<\/p>\n<p><img decoding=\"async\" class=\"img-responsive mw-700\" alt=\"\" src=\"\/eu\/wp-content\/uploads\/2024\/02\/Examples-of-mapping-benefits-to-value-drivers-and-KPIs.png\"><\/p>\n<p>For instance, if an intended benefit of implementation is to undertake parallel submission reviews and approvals, your value driver is reduced cycle time. A relevant KPI could then be the average time that a document sits in review or approval. Alternatively, your value driver might be improved quality (e.g., so that your business has better access to approved documents to build submissions), in which case the data required could be the percentage of submissions approved without health authority questions.<\/p>\n<p>While it may be tempting to try and measure every possible improvement, a focused approach pays off. The most effective way to build stakeholder buy-in and ensure good governance is to have an executive-level sponsor for each KPI, which means only having as many as necessary. Involve subject matter experts to select between 10 and 15 KPIs that can be tracked over time. Once these have been confirmed, clarify roles and responsibilities within your team for collecting and reporting data.<\/p>\n<p>Baseline KPIs are an important part of the measurement approach. Occasionally, baseline metrics can be sourced from data captured in legacy systems before implementation. If this isn\u2019t possible, then a snapshot six months into the program may work as a substitute baseline. Some of these KPIs will later change, but that shouldn\u2019t put you off. As Davies Karvonen notes, \u201cValue realization means using the KPIs you\u2019ve created.\u201d<\/p>\n<h2>Telling your story to the business<\/h2>\n<p>A critical component of stakeholder management is communicating the benefits of your transformation program. Teams that take a 360-degree view of their stakeholders are better placed to select the most persuasive arguments. Knowing who the decision makers and influencers are in the process means you can step into their shoes to determine the benefits that matter most to them. Each group will have its lens, and your storytelling has to address their perspectives to win hearts and minds.<\/p>\n<p>Less is more when telling your story to the business. The global head of regulatory operations emphasizes, \u201cBusiness cases that are 50-80 slides never go anywhere. If you need 80 slides, you don\u2019t have a good story to tell. Only include your strongest arguments, and it should take no more than 10 slides.\u201d<\/p>\n<p>Keeping the wider audience close and informed also generates dividends in the long run. When stakeholders lack a good understanding of the business case, their default response is often \u2018no\u2019. They advise, \u201cMemories are short, and new people will join while others will leave. Maintain a record of what you\u2019re doing and keep repeating the key messages from your story.\u201d<\/p>\n<p>Finally, leading companies don\u2019t wait to take action as data starts coming through. For instance, if one area of your business is moving slower than expected, it\u2019s worth adapting resourcing across functions. This strengthens the value realization story once the new platform is live.<\/p>\n<h3>Embracing \u2018transformation as usual\u2019<\/h3>\n<p>Developing a robust business case for a multiyear process is challenging, but it is always reinforced by a systematic approach to collecting data and measuring value. Good data will address stakeholder questions, and serve as a continual reminder of the tangible business value delivered and how transformation supports the company\u2019s mission.<\/p>\n<p>The global head of regulatory operations concludes: \u201cWe learned that siloed systems were shaping our activities. As we implement Veeva, we have \u2018aha\u2019 moments as the teams realize that we can change our dynamic, footprint, and ways of working.\u201d<\/p>\n<p>Register to attend <a href=\"\/eu\/events\/rd-summit\/register\/\">Veeva R&#038;D and Quality Summit<\/a> in Madrid to learn about regulatory transformation.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Developing a robust business case for regulatory transformation is challenging. Two biopharmas explain why it is always strengthened by a systematic approach to collecting data and measuring value.<\/p>\n","protected":false},"author":375,"featured_media":76121,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"product":[1019],"area":[976],"coauthors":[1627],"class_list":["post-76118","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","product-submissions","area-regulatory","blog-area-rd","blog-product-content-management","blog-product-data","blog-product-master-data-management","blog-product-multichannel-crm","blog-html-content-yes"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/posts\/76118"}],"collection":[{"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/users\/375"}],"replies":[{"embeddable":true,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/comments?post=76118"}],"version-history":[{"count":7,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/posts\/76118\/revisions"}],"predecessor-version":[{"id":76204,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/posts\/76118\/revisions\/76204"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/media\/76121"}],"wp:attachment":[{"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=76118"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/categories?post=76118"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/tags?post=76118"},{"taxonomy":"product","embeddable":true,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/product?post=76118"},{"taxonomy":"area","embeddable":true,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/area?post=76118"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/coauthors?post=76118"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}