8 DECEMBER 2024LIFE SCIENCES REVIEWIN MY OPINIONIN MY OPINIONhen one thinks about recent innovations and hot topics in clinical development, big-ticket items like AI, technology, data science, and analytics come to mind. Advancements in each of these fields are now being more widely used and finally making a positive impact on bringing new drugs to market more efficiently. Other `hot' areas include data privacy, health equity, clinical trial diversity and the need to manage R&D's impact on the greenhouse effect. All in all, these elements make this one of the most interesting times to work in clinical development.However, when I get asked by teams to support projects, I find myself time and again coming back to more basic strategies that involve the culture and behaviors of such teams especially when it comes to challenging the status quo and acting with a sense of urgency. These are not often discussed as they are somewhat opaque and fuzzy in an industry that prizes things in black and white, standard operating procedures, governance and formality. Until humans are replaced by the technologies I alluded to at the start of this piece, we will always need to manage culture and relationships. If managed well, they drive performance.I will share two small actions in a little more detail to illustrate what I mean. I was recently asked to support a project team charged with accelerating a clinical trial expanding into Asia Pacific. Upon assessing the situation, we identified several target areas to focus on. Firstly, we noticed that it sometimes took more than a month to schedule site initiation visits after all the other formalities were completed. When the usual approach didn't work, the team didn't waste time before asking the customer's medical director to make contact, given their scientific seniority. Amazingly, one of these visits was brought forward by a whole month.Another obstacle we identified was the long time translations were takinga key step for document preparation in Asia. We discovered the source of the problem was the customer's preferred translation By Ken Lee, General Manager and Region Head, Clinical Development, Asia Pacific, Syneos HealthTHE SIMPLE THINGS IN LIFE ARE STILL THE BEST, EVEN IN CLINICAL DEVELOPMENT Ken LeeW
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