In partnership with Trilogy Writing & Consulting Plotting a course toward I
n Malcolm Gladwell’s book, the Tipping Point, Gladwell shares how the Cambell Soup Company’s Prego pasta sauce brand went on a journey to find the best sauce with the goal of beating the market leader (Ragu at the time). What Prego discovered was that there are many perfect sauces and people have preferences to meet personal needs. One sauce would not suffice and today the pasta sauce epiphany cuts across every grocery aisle and product; filling shelves with an overabundance of mayonnaise, mustard, bread and other choices to meet a consumer’s needs. I’m sure most of us agree we wish finding the perfect technology were as simple as buying pasta sauce! Even with choices, today’s technology options provide partial solutions that don’t always meet all of industry’s requirements. Buyers should not be wary, however, as the important thing to remember is that today’s technology has potential to be highly scalable and extensible if you make the right choices. Increased attention on content automation has advanced significantly over the past two years, largely due to the commercialisation of Generative AI and the potential 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:
Just 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.
Clinical Trials Insight /
www.worldpharmaceuticals.net
Regulatory
content automation
With Generative AI reshaping content automation, organisations must ensure they select technology that is scalable and fit for purpose. Here Vladimir Penkrat, associate vice president – regulatory affairs at Indegene, parent company of Trilogy Writing & Consulting, discusses strategies for evaluating and adopting such technologies.
Most organisations in Life Sciences have a technology function that can partner with medical writing to own the burden of technology assessment; most usually assessing core IT-related functional requirements to ensure a provider can pass the muster of technical assessments.
Additional support from the IT function plus the data sciences function can ensure the AI supplier is 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, organisations 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 where you want to go: 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
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Clear goals, thorough evaluation, and effective collaboration are essential to harnessing AI for efficient, precise, and scalable medical writing.
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