On 26 April 2023, the European Commission (EC) proposed reforming the European Union (EU) pharmaceutical legislation. This revision constitutes the first major overhaul of the pharmaceutical legislation since 2004. It will adapt the legislation to the needs of the 21st century.
Meet the team who make it happen Andrew Feigin Chief Medical Officer Brett Gordon Associate Vice President, Project Delivery Peter Schmidt President & Chief Scientific Officer Andrew Feigin Chief Medical Officer Brett Gordon Associate Vice President, Project Delivery Peter Schmidt President & Chief Scientific Officer
For the first time, some children with life-threatening food allergies can safely eat in the school cafeteria and celebrate at a friend’s birthday party without fear of accidental allergen exposure. That’s not just progress—it’s the kind of outcome that reshapes lives and changes what’s possible in clinical development.
Sponsors are generally aware of the commonly held Type B FDA meetings, from pre-IND to End of Phase 2 (EOP2) to pre-NDA/BLA, but how often do you take advantage of additional Type C meetings for agency feedback? Continued discussion and input from the agency can be very beneficial, even outside of the milestones that allow for a Type B Meeting.
About Rho A trusted CRO partner for 40 years A trusted CRO partner for 40 years The Cohesion Effect: Where science, strategy, and people come together For 40 years, Rho has been more than just a contract research organization—we’ve been a trusted ally in clinical development, working alongside sponsors to
According to the Study Data Technical Conformance Guide (October 2024), sponsors should prepare a document called the study data standardization plan (SDSP) for each of their development programs to describe the submission of standardized non-clinical and clinical study data to the FDA.
Trust your data. Power your decisions. The Clean Data Principle: When Precision Drives Progress What’s the foundation of confident decision-making in clinical research? High-quality, reliable data. In every trial, data is your most powerful asset—but only if it’s accurate, timely, and aligned with protocol requirements. At Rho, our data management
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Plan for success with end-in-mind clinical trial design Plan for success with end-in-mind clinical trial design The right strategy today shapes the approvals of tomorrow Every clinical trial is more than just a study—it’s a carefully mapped journey toward regulatory approval and market success. At Rho, we believe in designing
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