4 Step Action Plan for Digital Transformation in Mid-Sized Pharma

digital transformation action plan

Digital Transformation is a very broad concept, but at its core it means leveraging computers and other digital technologies to fundamentally change the way a business operates. A simple example…Uber transformed the taxi industry by combining a mobile application for users, a digital dispatching system and a digital payments model. 

For Pharma companies, digital transformation means a shift to software technologies including AI, so-called “big data” and the internet of things to create new ways of developing, testing, manufacturing and delivering drugs and therapies. 

An example: As cancer drugs become personalized to an individual’s DNA, we need new ways to manufacture and deliver those drugs. Our current models for mass-producing generic medications will not meet the new requirements. Meeting those types will require transformational changes in the pharma industry, requiring whole new business models and processes. 

Why is Pharma Digital Transformation a Hot Topic Now? 

Because it is happening as we speak! The rapid advancements in research are demanding new ways to test new therapies, to engage with customers, and to manufacture and deliver drugs.  

Here is another example. Today, it is common to ask a patient to wear a monitor of some sort to collect diagnostic data. That means we need new ways to collect, transfer and analyze that data. Our old systems and methods are not designed for those tasks, so the advancements in science are not matched by the advancements in our processes. 

The question also touches on the regulatory model in the regions in which we operate. Regulators are also implementing new requirements that assume or even require digital capabilities regarding how we manufacture drugs, so pharma companies must invest in systems that meet those requirements. 

What Action Plan Is Required to Deal with Digital Transformation? 

It comes down to two words: assessment and investment. Every pharma company needs to look carefully at how they test drugs, how they manage quality, and how they meet regulatory requirements and invest in those areas. We can break down assessment and investment into four important steps: evaluate the current state, develop a transformation strategy, invest in the right technologies, and monitor, measure, and adapt where necessary. Let’s look at each a bit closer. 

Evaluate Current Operations 

Evaluate the current quality, regulatory, and document management processes and identify areas that can benefit from automation and digitization. In each area, look at your operations and score themselves on a “maturity model” to assess their current systems and processes. This should include an assessment of the existing documentation practices, quality control measures, and regulatory compliance procedures to identify gaps and opportunities for improvement. The evaluation should also include an analysis of the current IT infrastructure to ensure it meets the requirements of quality and regulatory standards.  

Develop a Digital Transformation Strategy 

Develop a comprehensive digital transformation strategy that aligns with the overall business objectives and regulatory requirements. The strategy should focus on improving the quality of the products and services, ensuring compliance with regulatory requirements, and enhancing the document management process. This strategy should also include the identification of digital tools and technologies that will be implemented to improve quality, regulatory compliance, and document management. You don’t have to implement the strategy all at once. Instead, consider starting with one or two quick wins that will prove the value of transformation and ensure buy-in from your executive team.  

Invest in Digital Technologies 

Invest in the necessary digital technologies to execute the strategy. This may include investing in new software, hardware, and other technologies such as electronic document management systems, electronic quality management systems, and automated regulatory compliance tools. You may also consider partnering with technology providers to gain access to the latest technologies and expertise in quality, regulatory, and document management. 

Monitor and Measure Progress 

Monitor and measure progress by tracking the implementation of digital technologies and assessing their impact on quality, regulatory compliance, and document management. Establish performance metrics to measure the success of the transformation, such as the reduction in the number of quality incidents, improved compliance with regulatory standards, and the reduction in document processing time. This will help to identify areas where further improvements can be made, and the strategy can be adjusted accordingly to ensure the continued improvement of quality, regulatory compliance, and document management processes. 

Digital transformation is critical for mid-sized pharma.  You need to make the investments required to climb up that maturity curve so that your company has the flexibility to respond to the rapid changes that have already started in our industry. 

A Great Opportunity for Mid-Sized Pharma 

What is happening in pharma, and especially in this region, is tremendously exciting. Pharma Digital Transformation is enabling pharma companies to create new ways of developing, testing, manufacturing, and delivering drugs and therapies. It is a hot topic now due to the advancements in research which require new processes.  

It’s important to develop action plans that include both assessing and understanding the investment required to meet regulatory requirements and climb the maturity model.  When we look back on this time, we will see that this is when some companies emerged as the leaders in the next generation of pharma companies in this region. If you need help understanding where to start in your company, reach out. We’d love to have a conversation.