The FDA, EMA and other international regulators are aggressively pushing for timely clinical trial protocol registration and clinical data disclosure. Manual, decentralized processes are expensive, inefficient and create a compliance risk as shortened timelines are almost impossible to satisfy.
Sylogent, the creator of the CTD PUBLISHER, has more than ten years of experience with protocol registration and results disclosure and is available to assist with regulation tracking and process improvements.
The CTD PUBLISHER can be deployed and ready to use within days. The system includes an integrated training module that assists with user on-boarding. The migration utility instantly downloads sponsor records from clinicaltrials.gov and EudraCT. The unique system configuration enables users to modify records quickly and get them approved for publishing.
The CTD PUBLISHER is guaranteed to streamline and simplify your global Clinical Data Disclosure (CTD). This web-based system is designed to standardize your process and data while reducing the efforts required by expensive resources. CTD PUBLISHER automatically imports data from excel spreadsheets, internal systems and or public websites and shares common data across the structured forms. The configurable workflows, with email notifications, ensure the work is completed on time and captures all stakeholder actions. Just push a button to upload to clinicaltrials.gov and to your CTD REGISTRY. Although the CTD REGISTRY generates an approved file, the new EU portal does not currently allow for automatic uploads.
US & EU Protocol Forms
US & EU Results Forms
ClinicalTrials.gov Auto Publish
EU Approved XMLs Files
Automated Data Imports
Customized Reports & Dashboards
Global Planner & Tracker
Study Master Form
80 Registration Templates
20 Results Templates
Workload & Resource Forecasting
Automated User Training
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