A late-stage oncology biotech developing a next-generation acute myeloid leukemia therapy faced a critical hurdle. The drug class’s established efficacy was shadowed by cardiotoxicity concerns, and the FDA required proof-of-concept evaluation outside the U.S. The sponsor needed an experienced oncology partner to design and execute a complex Phase I/II European trial that would meet regulatory expectations and generate the safety and efficacy data needed to advance development.
Worldwide was initially engaged for back-end services, including biometrics, medical monitoring, safety management, and medical writing. But, as site engagement declined and enrollment momentum slowed, the team expanded its role. Leveraging hematology/oncology expertise and established European site relationships, Worldwide strengthened oversight, re-engaged key stakeholders, and restored study momentum.
Read the full case study to learn:
- How Worldwide rescued a stalled oncology program, delivered critical proof-of-concept data, and earned a non-competitive award for global registrational development
- Why the Phase I/II trial successfully overcame enrollment, securing 22 patients across 9 sites in Italy and Poland, with no observed cardiotoxicities
- How we used the resulting data to support regulatory alignment with the FDA and EMA
- How during our Phase II/III trial, we enrolled 300+ patients across 50+ sites in 18+ countries
