Case Study: Palleos Healthcare achieves efficient, on-time execution of complex oncology trials with Medidata Solutions

A new partnership rooted in shared values of integrity and commitment to patients

Palleos Healthcare, a German full-service CRO specializing in oncology investigator-initiated trials, partnered with Medidata to address growing operational and regulatory complexity in modern clinical studies. Supporting academic partner Phaon Scientific, Palleos faced inefficiencies from non-core procedures, complex randomization and database needs, and pandemic-related recruitment and monitoring challenges that threatened timelines and budgets.

Using Medidata’s integrated Rave EDC and Rave RTSM (with future Acorn AI analytics), the partners delivered a single-platform solution that eliminated duplicate data entry, supported adaptive randomization and mid-study changes, and enabled remote patient monitoring. The approach kept the NeoMono Phase II trial on schedule—now the largest and fastest-recruiting immuno-oncology Phase II worldwide—with more than 150 patients enrolled across 25+ sites to date, while reducing administrative burden, risk and costs for sponsors and sites.

Palleos Healthcare

Renate Walter-Kirst

President