In the high-stakes world of clinical trials, timing is everything, but that doesn鈥檛 mean faster is always better. In the latest episode of Sharp鈥檚 Our Experience is Your Strength podcast, guests Melissa Peirsel and Sean McCaig join host Steve Jacobs to unpack what it really takes to avoid stockouts, bottlenecks, and surprises as your study moves from protocol to patient.
Together, they emphasize a recurring truth: the secret to speed is planning. While clients often approach CDMOs like Sharp with ambitious 鈥榝irst patient in鈥� timelines, Peirsel and McCaig explain that success starts by working backwards and building in time for every step, from label translation to comparator sourcing.
鈥淵ou need buy-in across departments,鈥� McCaig notes. 鈥淨uality assurance, label control, packaging, all have to move together if you want to meet compressed deadlines.鈥� Peirsel adds that rare diseases, orphan drugs, and adaptive trial designs only raise the stakes, especially when protocols change mid-trial.
Episode 3 鈥� Hurry up and wait! Avoiding delays and stock outs in your clinical supply
From push vs. pull models to auxiliary labeling and resupply triggers, Peirsel and McCaig deliver hard-earned insight into how sponsors can keep clinical supply running smoothly, without sacrificing quality, compliance, or sleep.
And when it comes to keeping supply aligned with demand? Sharp鈥檚 just-in-time strategies and integrated IRT systems are helping sponsors stay nimble, avoid waste, and mitigate overestimated enrollment figures.
This podcast is the third instalment in a series by Sharp, titled Our Experience is Your Strength. Across the episodes, host Steve Jacobs is joined by seasoned experts in formulation, sterile manufacturing, clinical supplies, commercial packaging, and sustainability to explore a range of challenges across drug development and commercialization, with a focus on getting the best results through contract services. Each episode draws upon key learnings gathered across Sharp鈥檚 decades of experience as a CDMO, helping to set listeners up for success with their chosen vendor.
Listen to episode 1 and 2 below:
