Prelude Partner VetDC Gains Full FDA Approval for TANOVEA® After CVM Remote Access Pilot Program

VetDC was granted full approval for TANOVEA® (rabacfosadine for injection) for the treatment of lymphoma in dogs on July 15, 2021. This was the first conditionally approved new animal drug for dogs to achieve the FDA’s full approval.

Prelude, the #1 eClinical technology provider in animal health, was a strategic partner in the TANOVEA pivotal clinical trial that formed the basis for full approval. VetDC was able to leverage many advanced features of Prelude EDC that enabled CVM to review critical data in an efficient and comprehensive way.

“The Prelude EDC system was instrumental in facilitating the initiation, conduct, and submission of the TANOVEA trial. We want to express our sincere appreciation for Prelude’s efforts to customize the Prelude Electronic Data Capture (EDC) system and to provide outstanding support to both VetDC and our investigators during the pivotal study.”

Steven Roy

President & CEO of VetDC

The FDA CVM’s EDC (Electronic Data Capture) Remote Access Pilot Program was a key component of this recent approval process, allowing CVM real-time access to the TANOVEA pivotal study database during their review. In addition to VetDC, Prelude has other clients participating in this pilot program, and we look forward to future success stories.