Bringing science and humanity: How systems thinking should shape clinical trial execution

As veterinary medicine mirrors the complexities of human pharmaceutical development, the industry faces a critical need for digital solutions that can handle the rigorous demands of biosimilar, specialty generic, and peptide studies.

At the center of this transformation is the need to optimize the most resource-intensive aspect of any trial: documentation.

The Growing Complexity of Veterinary Studies

Veterinary clinical trials are the backbone of animal drug development. However, managing the vast array of documents and regulatory processes required for successful submission can be overwhelming. Traditional methods of document preparation are often fragmented, time-consuming, and susceptible to manual errors.

As stakeholders in the veterinary sector, from pharmaceutical companies to Clinical Research Organizations (CROs), strive to bring innovative treatments to market faster, the "manual-first" approach is becoming a significant bottleneck.

Vilintra’s Generation Module: A New Standard in Accuracy

To address these challenges, Vilintra provides a specialized platform designed to simplify and enhance every stage of trial management. While our Management Module ensures seamless eTMF functionality and secure document exchange, it is the Generation Module that is redefining operational efficiency in the field.

Developed and refined in collaboration with leading pharmaceutical partners, the Generation Module serves as a cornerstone for digital transformation. For veterinary studies, this means:

• Automated Document Creation: By automating the generation of essential trial documents, the platform reduces manual effort by up to 40%.
• Precision and Error Reduction: Veterinary research requires precise calculations and data integrity. Vilintra’s solution has been proven to significantly cut calculation errors, ensuring that the study data remains robust.
• Regulatory Rigor: Compliance is non-negotiable. Vilintra adheres to the highest technical and regulatory standards, including GAMP 5, GDPR, HIPAA, FDA, EMA, and ICH guidelines.

Ensuring Data Integrity with Advanced Technology

In veterinary clinical trials, the immutability of data is paramount for gaining regulatory approval. Vilintra utilizes hashing technology to ensure the integrity of all documents throughout their lifecycle. This provides stakeholders with the peace of mind that their documentation is not only accurate but also fully compliant with global quality standards.

Shaping the Future of Animal Health

As Vilintra expands its scope to include biosimilars and specialty generics, our goal is to become the "gold standard" for clinical trial management across the EU, MENA, and global markets.

By integrating Vilintra’s generative capabilities into their workflow, veterinary researchers can shift their focus from administrative burdens to clinical excellence. The result is a more agile, data-driven approach to animal health that brings essential medications to the market with greater speed and reliability.