08.05.26 -- Every Stage Has Its Hurdles — Here's How Leading Teams Are Clearing Them

In drug development, a go/no-go decision can be a high-stakes trade-off between speed and certainty. Delve into the real-world operational and strategic hurdles to making those decisions.

Learn how, by embedding FDA engagement into the development process, sponsors can strengthen their abuse potential assessment and support smoother regulatory review.

Gain a practical framework for evaluating tools, identifying high-impact use cases, and making informed decisions about implementation and vendor selection.

Gain an auditors insight into common compliance gaps and learn practical ways to strengthen audit readiness in sIRB studies.

Smaller biotech companies often have very different clinical trial needs than large pharmaceutical organizations, and that includes RTSM.

Even straightforward trials create logistical friction. The right support keeps participants on track, reduces site burden, and ensures routine requests don’t turn into delays that impact study progress.

Selecting the right functional service provider (FSP) is a critical factor in advancing clinical research programs efficiently, and this reimagined FSP model prioritizes each client’s unique objectives.

Find a supply automation value engine with intelligent automation and algorithms to analyze drug supply data and automatically adjust delivery quantities to each site based on data available in IRT.

Kemi Williams broadens the definition of representation to include geography, literacy, age, comorbidities, sexual orientation, gender identity, and other factors, emphasizing that trials must reflect the populations most affected by a disease.