IN PARTNERSHIP
Navigating the ocean of choices to plot a course toward content automation
VLADIMIR PENKRAT, ASSOCIATE VICE PRESIDENT – REGULATORY AFFAIRS AT INDEGENE I
ncreased attention on content automation has advanced significantly over the past two years, largely due to the commercialisation of Generative
AI and the potential that this technology might provide in authoring documents for medical writers. The enthusiasm for Gen AI and the potential impact on medical writing has gone from excitement to a flood of information across the industry. The innovation overload with promises that AI will do all the writing makes it challenging to navigate the jungle of technological promises, leaving a medical writing organisation having to choose a tool that might address one or two document solutions, apply editorial support solutions, or be so paralysed by the options that they do nothing at all.
Getting started Understanding what technology can and cannot accomplish requires a scrutinising eye to self-educate, challenge suppliers, and ensure the solution presented creates an impact and adds value. Each organisation has its unique business needs to consider: the types of documents being authored, volume of work, standards and templates being used, approach to writing style, and communication, plus any existing use of technology. Most organisations in life sciences have a
technology function that can partner with medical writing to own the burden of technology assessment. Additional support from the IT function plus the data sciences function can ensure that the AI supplier is truly delivering on their promises. Knowing whether the supplier is leveraging third party large language models or strictly applying Robotics Process Automation with BPM process automation is important to understand both the supplier’s leverage
and approach. An additional consideration is checking that
there are controls to ensure that the outcomes from technology can be consistently produced. Apart from expertise in technology, domain and process, organizations need a technology supplier to demonstrate robustness in testing, consistency in performance of AI models, and assurances of business continuity in cases of any disruption in the underlying technology.
Knowing what you want to accomplish Whether to go with Generative AI or a rules-based solution might be less important than knowing what you want to accomplish. At the very core, consider the impact you would like to effect. Is there an overload of work? Is quality review a burden? Do you want to standardise and simplify processes through technology? Is the administration of content overshadowing the authoring effort? Or do you want to reduce administrative activities to allow medical writers to focus on medical assessment and judgement? Indicating a metric such as efficiency or
quality is a good starting point but should be further expanded with use case examples of where and how those metrics can be impacted by technology. Some flexibility and understanding of available technology should additionally be considered allowing you to access existing solutions, opposed to waiting for something not yet invented. Taking this one step further, the provider of the solution should understand how the solution is impacting your metric and be able to quantify a business impact. This score card and business impact calculation will allow you to independently derive a return on investment (ROI) once cost becomes part of the conversation. Assessing a new solution on the benefits for
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