Right Submission's CSR Platform
Right Submission’s CSR platform is a SaaS-based tool that creates high quality Clinical Study Reports for medical device companies in a guided process reducing resource requirements, cost, and time to submission.
Our software is pursuant to ICH E3 guidelines for Clinical Study Reports. It automatically applies technical and style standards, page numbering, and hyperlinking to your report for you. Global tokens allow changes to be made automatically across the entire submission. Your report will be created faster and better.
Integrate and manage your clinical data analysis into your report and upload your Section 16 appendices with ease. Merge your completed CSR into the 510(k) platform for premarket submission. Your resources will be focused appropriately.
The platform allows your team to collaborate effectively. Everyone has access to all the material assigned to them. Contributor, reviewer and approver roles are assigned. The software is cloud based and all work is accessible from anywhere with internet access from our secure server to authorized users. The database contains version history and allows rollback. Previous work can be reused. Your team will work seamlessly and effectively.
Our software reports your progress allowing effective project management and reporting to stakeholders. Your stakeholders will be informed and you can course correct earlier.