Case Study: Giuliani Pharma achieves streamlined, compliant multi-study eCRF, pharmacovigilance and secure data management with Ethical GmbH

Giuliani Pharma - Customer Case Study

Giuliani Pharma, a long-established gastroenterology R&D company, faced the challenge of managing multiple concurrent GED projects and clinical studies while ensuring secure, compliant data capture, pharmacovigilance, and remote document access. To meet regulatory requirements for validation and information security, Giuliani needed a segregated, role-based system for eCRF data entry, adverse-event surveillance, and controlled file sharing across studies.

Ethical GmbH delivered a tailored suite—CHORUS® the e-CRF® multi-study portal, SAFETY DB® Safety Database Management, and the E-Data Room® Virtual Data Room—providing study-specific roles, authentication, ISO 27001 infrastructure, GAMP 5/CFR 21 Part 11 validation documentation, AE form creation, CIOMS generation, and secure, auditable document access. Ethical GmbH’s solution centralized multi-study data capture, streamlined pharmacovigilance reporting for the QPPV, and enforced granular access and version control, enabling compliant safety reporting and secure remote collaboration across Giuliani’s projects.

Giuliani Pharma