Case Study: Fin-Ceramica Faenza Spa achieves streamlined post-market clinical data capture and remote follow-up management with Ethical GmbH (Ethical eClinical Solutions)

Fin-Ceramica Faenza Spa - Customer Case Study

Fin-Ceramica Faenza Spa, a biomedical company specializing in bio-ceramic materials and custom solutions for neurosurgery and spinal surgery, needed to meet post‑marketing and CE Marking (Directive 2007/47/EC) requirements for its CustomBone product and to run a web registry for its MaioRegen scaffold. To capture surgical data, enable remote follow-up entry by surgeons, report adverse events, and manage registry access for investigators and distributors, Fin-Ceramica partnered with Ethical GmbH to deploy dedicated eCRF platforms.

Ethical GmbH implemented the E-CRF CustomBone and E-CRF MaioRegen platforms, integrating import from the Custom Bone Service portal, remote web-based data entry, adverse-event reporting, built-in checks and alerts, visual visit tools (e.g., VAS), and query/export/reporting functions. The solution streamlined data capture and follow-up workflows, improved data quality and compliance with regulatory post-marketing obligations, and gave authorized users and study coordinators easy access to reports and exportable data for statistical analysis.

Fin-Ceramica Faenza Spa