Prelude Partner VetDC Gains Full FDA Approval for TANOVEA® After CVM Remote Access Pilot Program
By Editorial Team on July 28, 2021
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 Dynamics, 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. Steven Roy, President & CEO of VetDC, stated that “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.”
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.
“I highly recommend Prelude’s system and outstanding service to anyone looking for an efficient and cost-effective EDC solution.” – Steven Roy