CVM’s Office of New Animal Drug Evaluation (ONADE) has launched an initiative that will greatly increase the efficiency of the study submission process. They will now allow submissions through read-only access to online databases in lieu of the submission of copies of the data. Prelude Dynamics is participating in this pilot program with two study sponsors, and we are optimistic for successful outcomes in both. The primary advantages of allowing CVM direct study access as opposed to the submission of copies of the data are:
- For CVM: With access to the online database they will be able to view the data in a more natural, intuitive way. Spreadsheets do not provide the context that the full database can and are therefore not as suitable. With access to the database, CVM can view all the audit trail information right alongside the source data.
- For Sponsors/CROs: Online access eliminates problems with multiple file uploads and file size restrictions that make the current submission process cumbersome. The burden of “packaging up” study data in a eSubmitter-ready format is removed. Submissions will be faster and less costly.
Preliminary results with one EDC system are promising. Both CVM and pharmaceutical companies are enthusiastic for the future of the study submission process.
For studies to participate in the program, some documentation is required up front. Prelude Dynamics has also removed this burden from Sponsors and CROs by offering prepared templates for interested parties. If you are interested, ask your Prelude project manager for a template today! They can help you submit your information to the right people at CVM.