The FDA Center for Veterinary Medicine (CVM)’s draft guidance on pharmaceutical development for veterinary medicines outlines a systematic approach to ensure the quality, safety, and efficacy of veterinary drugs. The Cloudbyz eClinical platform, comprising CTMS, eTMF, EDC and Safety & Pharmacovigilance, can significantly enhance compliance with these guidelines. Here’s how the systems can be effectively utilized:

Cloudbyz CTMS

1. Study Setup and Planning: Cloudbyz CTMS can manage and streamline the entire study setup process, ensuring adherence to FDA guidelines on pharmaceutical development. As the guidance states, “The Pharmaceutical Development section should describe the knowledge that establishes that the type of dosage form selected and the formulation proposed are suitable for the intended use” (p. 2). Efficient management of study protocols, schedules, and milestones supports the systematic approach recommended by the FDA, facilitating a structured and compliant study setup.

2. Study Execution and Monitoring: Our system facilitates real-time tracking of study progress, monitoring of clinical trial sites, and management of investigator performance. According to the guidance, “The sponsor should demonstrate an enhanced knowledge of product performance over a range of material attributes, manufacturing process options and process parameters” (p. 2). Continuous monitoring and real-time updates ensure that trials adhere to the established protocols and regulatory requirements, improving compliance and data integrity.

Cloudbyz EDC

1. Data Collection and Management: Cloudbyz EDC ensures accurate and efficient data collection directly from clinical trial sites, supporting the FDA’s emphasis on data quality and integrity. The guidance notes, “Information from pharmaceutical development studies can be a basis for quality risk management” (p. 1). Automated data validation checks within the EDC enhance data accuracy and reliability, which is essential for pharmaceutical development documentation.

2. Integration with Other Systems: Cloudbyz EDC can integrate with laboratory information management systems (LIMS) and other databases to streamline data flow. Seamless integration reduces manual data entry errors and ensures comprehensive data collection, aligning with the FDA’s quality guidelines and facilitating efficient data management.

Cloudbyz Safety and Pharmacovigilance

1. Adverse Event Reporting: Cloudbuz Safety and PV facilitate the timely reporting and management of adverse events, as required by the FDA. The guidance highlights, “Quality risk management can be used at different stages during product and process development and manufacturing implementation” (p. 14). Real-time tracking and automated alerts ensure that adverse events are reported and managed efficiently, supporting patient safety and regulatory compliance.

2. Risk Management: Our safety database supports the identification, assessment, and mitigation of risks throughout the trial lifecycle. Proactive risk management aligns with the FDA’s guidelines on quality risk management, ensuring robust safety monitoring and reporting.

Cloudbyz eTMF

1. Document Management: Cloudbyz eTMF systems ensure that all essential documents are accurately filed and easily accessible, supporting FDA guidelines on documentation and transparency. Efficient document management ensures regulatory compliance and facilitates smooth audits and inspections.

2. Lifecycle Management: Our eTMF system supports the entire lifecycle management of trial documents, from planning through to archival. Proper document management ensures that all phases of the trial are well-documented, supporting continuous improvement and regulatory adherence.

Leveraging Cloudbyz Veterinary eClinical for the pharmaceutical development process for veterinary medicines not only enhances efficiency but also ensures compliance with FDA guidelines. By leveraging our CTMS, EDC, eTMF and Safety Database, organizations can streamline their processes, ensure data integrity, and maintain high standards of quality and safety in their veterinary drug development efforts.