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The Art of Simplifying Pharmacovigilance – Part V: Deconstructing Automation

The use of automation continues to be on the rise, and that trajectory is not slowing down anytime soon, if ever. In relation to pharmacovigilance, automation’s ascent and how it is impacting the industry is especially significant. This creates multiple critical decisions for manufacturers to consider sooner rather than later.

So, where to begin? If you ask these three vital questions, you will have a fair idea:

  1. Are you fully harnessing the potential of your current safety database application to the fullest?
  2. What is the volume of cases you process in each of the case types you receive?
  3. What is the break-even point for you if you invest in newer technologies?

To address the first question, there are nearly 25 different possible ways to automate your case processing software application and get more out of it in terms of improving efficiency, standardizing the output, and aiding in quality improvement. These can be done by the deployment of rule-based automation and the implementation of edit checks. This is commonly referred to as Robotic Process Automation (RPA).

To explore the second and third questions, after the raw data has been populated, deconstruct the case count by case types (spontaneous, clinical trial, regulatory authority, literature abstracts and full-text articles, and business partner cases). Next, visualize them through the lens of one question – is it organized and structured, or is it disorganized and unstructured data? Classify the count of all cases received through any adverse event form in Excel as the structured dataset. The unstructured data should comprise a count of received cases presented in raw text format, without being pre-filled into a predefined set of standardized fields.

Create a business case to evaluate the Net Present Value (NPV), which determines the investment’s value – in this case, the investment needed to automate – by considering the time value of money. Calculate the difference between the present value of cash inflows and outflows over a specific period and what potential savings are gained by optimizing the resources. A positive NPV indicates profitability, while a negative NPV suggests financial unviability.

The next natural key question is how you will choose whom to work with. In my recent blog, “The Art of Simplifying Pharmacovigilance – Unlocking Efficiency through Consolidation,” I discuss the benefits of a vendor who can work as your partner and take care of everything you need under one consolidated umbrella. The team with the highest subject matter expertise, experience of having implemented it in real-life situations, and lived through the benefits realization journey would be the most suitable option. Complementing each of these factors is the added benefit of having a vendor who has a strategic partnership with the popular industry standard software, Oracle, and thereby can offer the most competitive pricing.

Dr. Vivek Ahuja
Senior Vice President for Delivery Excellence, Strategy, and Growth, PV, Quality, and Regulatory Services

Dr. Vivek Ahuja serves as EVERSANA’s Senior Vice President for Delivery Excellence, Strategy, and Growth (PV, Quality, and Regulatory Services) with over 22 years of experience across multiple functional offerings including Pharmacovigilance, Clinical Research,…