09.03.26 -- Faster FDA Pathways, Smarter Partnerships: Rethinking How Trials Get Done

HRPPs and IRBs play different but connected roles in protecting research participants. Hear expert guidance, firsthand experiences, and questions that can help people make more informed decisions.

Racing to bring a therapy to patients? Explore FDA's six expedited pathways—Fast Track, Breakthrough Therapy, QIDP, RMAT, Priority Review & Accelerated Approval—and find your best fit.

The FDA’s real-time review pilot signals a massive shift in clinical operations, where continuously regulator-ready data becomes the foundation of future trial execution.

Gene therapy requires early, rigorous safety planning and command of pediatric and biosafety rules. Early committee engagement reduces delays and strengthens high‑stakes trials.

Prepare for ICH E6(R3) with integrated oversight, audit-ready data, and streamlined trial operations designed to reduce burden, accelerate timelines, and support compliance.

Leverage Altasciences’ DDI expertise to assess interaction risks, generate critical data, and support informed decisions throughout drug development.

Many clinical organizations believe they must clean data and unify systems before adopting agentic AI. New approaches show teams can start now, create value faster, and improve readiness as they scale.

Multi-vendor trial models often limit visibility and coordination. Discover how centralized operations can streamline workflows, control costs, and improve stakeholder experiences.

Modern RTSM capabilities help streamline study execution, support compliance, and provide greater visibility across complex global clinical trials.

Learn how modern, model-based dose-finding methods can replace outdated 3+3 designs and drive faster, smarter early-phase oncology decisions.

Move drug development into the modern era with a CRO that offers assay development and validation, bioanalytical testing, sample prep, and more.