Case Study: Cancer Research Organization achieves regulatory clarity to include German IND sites with Advarra

Cancer Research Organization - Customer Case Study

Cancer Research Organization, running a multinational Phase III drug trial, faced a sudden 2018 German regulatory change that threatened including German sites as IND sites unless sponsors produced a comparative analysis and educated sites on US-specific requirements. They engaged Advarra Consulting (Advarra’s global regulatory consulting service) to rapidly assess feasibility and deliver the required comparative analysis.

Advarra produced a trial-specific, side-by-side table mapping each US investigator requirement to its German and European equivalents (including ICH GCP E6 (R2)), a simplified investigator-facing summary, and assessments of equivalency or conflict with proposed remedies. As a result, the Cancer Research Organization was able to proceed with planned German site expansion, achieve on-time protocol implementation, and obtain regulatory assurance and practical tools to ensure compliance.