The success of any clinical trial — and the biotech organization behind it — hinges on how well data is managed from design through submission.
Poor data strategy is not just inefficient - it’s risky, leading to inconclusive trials, costly mid-study rescues, regulatory delays, and even refusal-to-file decisions that can derail an entire development program.
As data volume, protocol complexity, patient diversity growth, and pressure mounts to accelerate timelines under regulatory scrutiny, data strategy must be treated as a core, not tactical, concern. Yet traditional outsourcing models often continue to focus heavily on clinical monitoring, with data strategy often relegated to an afterthought – sometimes just two slides at the end of the bid defense meeting.
To gain a scientific and commercial advantage, and to mitigate risk of failure, biotech sponsors are embracing specialized, best-of-breed partnerships that embed data expertise from the start. These partnerships treat data as a critical asset and source of insights, empowering smarter decisions across trials and programs.
In this panel discussion, drug development experts will explore how forward-thinking biotech companies are reimagining their approach to outsourcing –and transforming data risks into opportunities. Topics will include:
- The benefits of the trial statistician or ‘design architect’ having a seat at the table from the earliest planning stages and throughout study conduct to deliver better R&D outcomes.
- How data-focused partnerships, embedding quality by design principles, help sponsors anticipate regulatory requirements, reduce downstream risk, and pave the way for submission success.
- What value data specialization enables across the trial lifecycle— from design and data collection set-up, to spotting risks early through in-stream monitoring, and speeding up final reporting by working smarter earlier in the process.
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Register now →Meet the Speakers
Moderator
Ben Dudley
Chief Commercial Officer, MMS
Mary E. West, MS
SVP, Clinical Development Operations, Tectonic Therapeutic
Irving Dark
Biometrics Thought Leader
Kim Hacquoil
Statistical and Data Science Leader, MMS
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