Health Care

Innovation or Stagnation: Overcoming the Challenges of Model Governance in Life Sciences

Life Sciences organizations have never had more critical time to adopt strategies that help them balance risk mitigation and refuel innovation. AI creates many exciting opportunities for these organizations to drive breakthroughs faster than ever before. Not surprisingly, 66% of life science companies are already using Generative AI to enhance operations. This number will continue to grow as more organizations use AI to sell new drugs, medical devices and other products faster.

However, life science organizations operate in a highly regulated, high-risk environment, and safety must always be first come first come safety. That’s why having a strong model governance is absolutely crucial. AI Boom highlights the importance of organizations having visibility and control over their data, especially as regulatory requirements develop and grow.

Despite the availability of modern governance solutions, many life science organizations still take a largely manual approach to modeling governance. However, this outdated strategy hinders innovation, creates silos, and becomes increasingly unsustainable in today’s rapidly changing landscape. By viewing model governance as an active and integral part of operations rather than a box to check facts, life science organizations can maintain compliance, better allocate resources and gain competitive advantage.

Let’s take a closer look at how life science organizations deal with today’s model governance and how they can modify their approach to improve business outcomes.

Take a risk-based approach

Generally speaking, life science industries like medicines are highly risky. This makes sense too. When people’s lives are largely the most important. However, adopting a risk-based approach (the most critical risk of organisations focusing on patient safety, rather than the most critical risk of conducting the same review in all aspects of their operations) is the best strategy to protect patients) is the best strategy to protect patients. and Promote business plans forward.

What does this look like in action? Risk-based approaches can help pharmaceutical companies sell their drugs faster without compromising safety. Speed ​​is the name of the game when the game is developed, and even spending an extra day or two to approve the model can have a significant financial impact. To introduce this, “big pills” generate up to $2.7 million a day, so adopting a risk-based approach to accelerate operations will in turn unlock huge unrealized unrealized financial potential.

Manage processes, not documents

Many life science organizations still rely on a combination of manual processes and different tools to perform model governance: they have tools to manage processes, such as workflow orchestration and business tool families, and quality management systems (usually based on Excel) to manage compliance. The goal should be from managing documents and different tools to managing process.

Embed governance directly into tools that organizations rely on execution processes improves efficiency and, perhaps most importantly, overall visibility into the process can be improved. This enables life science organizations to define their plans and methods to develop models/analysis while being able to relate to the work efforts and relate to the plan. In addition, life science organizations can document and demonstrate that the process is followed to generate these work items. Ultimately, this will automatically guide and limit the process and the next step to ensure the process is aligned.

Adopt automatic solutions

Life science organizations may hesitate or slowly adopt automated governance solutions because of preconceived notions about their talent, budget and time investment perspectives. And, historically, automated model governance Have done it It requires a lot of time and resources. However, modern solutions do not require organizations to hire new talents or spend a lot of time overhauling their infrastructure to experience the benefits of automated governance.

Today’s systems can be easily connected to your organization’s existing tools, providing automatic versioning, tracking and repeatability for compliance. As a result, life science companies can allocate resources more efficiently because the time spent on manual governance processes. This can improve their talents and focus on making more impactful contributions to the business.

Join the entire team

Whenever an organization introduces a new way of doing things, there is usually a certain degree of resistance. As life science organizations transition to modern approaches to model modern approaches to governance, it is important that they must educate on the appearance of new strategies. Model governance is not something to fear, nor is it just another obstacle that will slow down: it is just a process guardrail that allows them to get their work done more effectively and focus their energy on different areas.

Education teams educate on the reasons behind adopting any new technology and are transparent about how it will affect their day-to-day work. Organizations should emphasize the allowance for automatic governance: to let employees excite themselves to release it to what they actually like to do, whether it’s programming, AI development, or other areas.

Modern governance solutions quickly become a necessary condition for life science organizations to keep up with changing regulations, maintain compliance and support innovation. As AI continues to spread, the demand for these solutions will only become more obvious. It’s time for life science organizations to rethink their approach to model governance in order to speed up breakthroughs and market life-changing innovations faster.

Image: tuk69tuk, Getty Image


Christopher McSpiritt is Vice President, Domino Data Lab’s Life Science Strategy. He promotes understanding of customer needs and works with product management and marketing teams to drive a methodology to market in the life sciences. When Christopher joined a small eClinical startup in 2005, he began to focus on the life sciences industry. Since then, he has had the opportunity to work as a project manager, business analyst, consultant, product manager and strategist in consulting companies and leading software companies.

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