Emerging biotechnology companies are increasingly required to launch complex clinical trials under aggressive timelines, constrained budgets, and lean internal infrastructures. Traditional operational models and rigid outsourcing structures can create inefficiencies that delay study start-up, slow decision-making, and hinder execution.

This session will explore how agile clinical operations strategies, fit-for-purpose resourcing models, and collaborative sponsor/contract research organization (CRO) partnerships can accelerate study start-up while maintaining quality and oversight. Drawing from real-world experiences across Phase I-III global clinical programs, attendees will gain practical and proactive approaches for improving cross-functional alignment, streamlining communication and governance, managing start-up risks, and implementing scalable operational models that support efficient trial execution in today’s evolving clinical development environment.

CEU: 1.0 ACRP

Speaker:

• Shaily Garg, CEO, Exact Clinical Research