And the FDA has approved Amgen’s Uplizna for adults with antibody-positive generalized myasthenia gravis, adding a ...

Explore how expanding clinical trials into community and nontraditional sites, simplifying protocols, and leveraging AI can ...

See how combining human oversight with AI insights improves protocol authorship, site selection, and monitoring strategies, ...

In today’s ACT Brief, we break down FDA’s new superiority requirement reshaping CAR-T development, examine Pfizer’s global ...

This pilot project evaluated whether targeted training could strengthen clinical research capacity at community cancer centers, improve readiness to conduct oncology trials, and support more inclusive ...

Explore how AI can optimize study design, speed patient recruitment, and streamline operational workflows to shorten ...

ACT: As new ICH GCP guidelines roll out, how are sponsors balancing the drive for innovation—especially in areas like CAR-T ...

Strong relational governance between technology vendors and sponsor–CRO teams is becoming a critical foundation for eCOA ...

In today’s ACT Brief, we explore how stronger vendor–sponsor governance is speeding eCOA study startup, hear from AMR ...

Gain insights into the operational challenges facing clinical research sites today, learn what sponsors and CROs can do to ...

In today’s ACT Brief, we look at how AI and in-silico methods are reshaping drug repurposing, why staggered ICH GCP rollouts ...

In today’s ACT Brief, we highlight new insights from McKinsey on where AI can meaningfully accelerate clinical development, break down the emerging design and regulatory forces reshaping obesity drug ...