Regulatory software for clinical trials helps teams manage the planning, submission, and tracking of documents needed for regulatory approval. It organizes regulatory data, deadlines, and correspondence in one system. This includes trial applications, ethics approvals, amendments, and ongoing reporting requirements.
The software supports collaboration between sponsors, sites, and regulatory teams. It tracks submission status, ensures correct document versions, and maintains full audit trails. Many systems include task reminders, compliance checks, and integration with eCTD and eTMF systems. This helps reduce delays and ensures that all regulatory steps are completed on time.
