IN PARTNERSHIP


the team and impact on the process of medical writing will ensure your decision making is not burdened by technical decision points (e.g. API integration) that will add value eventually, but should not drive your decision making in how technology will help the medical writing team.


Setting a course Knowing your priority is important but also understanding if you need a roadmap of capability (e.g. adding document types / addressing other steps of the medical writing process) should be considered. Whether your roadmap is short and with limited documents and milestones or long and intended to drive value across the content continuum can ensure you select a partner that is prepared not only with solutions but also the same vision that you have. Either way, establishing a plan, securing


stakeholder buy-in from partners in IT, ensuring there is executive sponsorship and medical writing subject matter experts prepared to evaluate solutions will ensure you build the right team to drive a collective decision. Budget naturally enters into the equation but should not be a starting point as this constrains the evaluation process. Cost and budget are worthy discussions once other considerations have been properly assessed. If you are looking to consider a roadmap- based approach, be prepared to pilot a solution as an opportunity to evaluate its effectiveness. When Generative AI is introduced, medical writing resources often need training on Generative AI. Ask your partner if they can support this. Training will reduce the potential distrust of the solution and ensure medical writers maintain an open mind to the advantages the technology brings. Another important consideration in the


evaluation of a pilot solution is the implementation roadmap. Planning out the sequence of releases of either additional documents or capability should include ongoing assessment of the outcome experience and impact. Be sure to calculate this before you move onto the next release. The long term view and the solution components should in many ways be interconnected so that if you enable a specific


10 | Outsourcing in Clinical Trials Handbook


document, this contributes to the automation of another document further in your roadmap. This can ensure that the goal of automating the content continuum is logical and sequenced, and solutions can both build onto other documents and in some cases can be repurposed for different documents as well. Medical writers should assess if the solution


builds confidence in the accuracy of the output being produced by the technology. If the technology being evaluated is not able to show how it is performing an activity that changes text or data then the perceived risk by a medical writer is high and decreases the value of the system. Medical writers also do not benefit from poorly written text, so unless the technology is able to apply best practices in medical writing then any text written by a machine will have to be re-written by the medical writer, negating the perceived benefit. Solutions that can assist the medical writer in the decision-making process have the greatest chance of adoption since they keep the medical writer in control of the final document. Medical writers value the practitioner’s


approach to authoring, applying best practices that ensure consistency in the delivery of the message. Technology, however, may require new ways of working to drive acceleration and efficiency. Medical writers don’t always author a complete document in one day and they need to pick up where they left off or even create an environment where their peers can pick up where they stopped. These natural ways of working must be factored into the assessment of effective or ineffective writing solutions.


Reaching your destination Keep in mind that any change that has an impact on the process may require upskilling of resources and training to ensure compliance. As each incremental technology solution in your roadmap builds on the last, be prepared to include a team of technical, subject matter, business process, and executive sponsors in the initial planning and incremental evaluation of your content continuum roadmap. Doing this will ensure both quick wins and effective long term outcomes as you achieve your content automation goal.


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