Manage clinical trials, track quality processes and organize regulatory submissions.
Gain a DMS specifically designed for life science organizations
Connect all trial participants and processes in a single location
Quickly create documents with pre-made forms and templates
Boost productivity with automated workflows, notifications and reporting
The Regulatory module reduces the time and complexity involved prior to submission, providing a consolidated and authoritative source for regulatory submission content. With the Regulatory module, you can manage administrative and archiving tasks more efficiently, streamlining your business processes while saving time and resources. Furthermore, it fully integrates with eCTDmanager allowing documents to be added to a submission directly using drag-and-drop.
EXTEDO’s electronic Trial Master File (eTMF) based Clinical module gives you the convenience to connect all trial participants and processes in a single, cloud-based application and ensure best practices by documenting all activities. Rapidly deploy solutions with standardised templates, and capture every process in end-to-end workflows. Now you can rest assured that your processes are consistent with complete inspection-ready trial documentation, faster than ever.
Site monitoring activities and quality management are expensive, time-consuming and notoriously difficult to be undertaken remotely. The Site Monitoring module add-on for eDOCSmanager provides you with a ready-to-use, pre-validated cloud-based application that allows clinical sites to securely upload source files to a common repository. Now, you can monitor and review source files, make notes, and complete quality management tasks, or assign them to site administrators with notifications and tracking capabilities.
Automatically review workflows on documents when they are close to their expiry by adding the SOP module to eDOCSmanager. Generate employee records for target groups based on approved SOPs and create quizzes to guarantee new processes are understood by your team. The built-in controlled print functionality ensures that paper-based copies are managed properly throughout the entire process, ensuring you stay organized and up-to-date.
The Quality module add-on connects every action, from the initial issue to the new process. Every step is documented, reviewed, and approved through a complete, closed-loop process from initial issue to preventative action. It comes ready-to-use with standard forms and processes, but can be easily adapted and tailored to current procedures. Automated distributions are made for review, approval, and notification with complete signed records and audit trails. Now you can be ready for inspection, every time.
eDOCSmanager is a secure, cloud-based document management system for life sciences organizations. It is fully GxP compliant and integrates with EXTEDO’s submission management solutions.
Tailored specifically to the needs of regulatory and related stakeholders, EXTEDO’s business process and regulatory consulting services are designed to support you during and after your eCTD submissions. Through a series of workshops, our team of experienced consultants will establish your business needs, understand your processes, and help you to define the most appropriate implementation approach.
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOpulse solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.
Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.