RLPmanager - Report Level Publishing Software
Automated creation & publishing of clinical study reports with RLPmanager
RLPmanager is EXTEDO’s advanced solution for report level publishing; it has been designed to optimize pre-publishing work and support clinical study departments in managing and publishing clinical and non-clinical study reports that later become part of eCTD or NeeS submissions.
RLPmanager can be deployed as stand-alone solution or be integrated, as an extra license option, with eCTDmanager, EXTEDO’s electronic submission management software. An integration of RLPmanager and eCTDmanager covers the complete process of study creation, compilation and integration into submissions and facilitates cooperation between clinical study and regulatory affairs departments.
Maximum flexibility in study creation
Reduced approval times and time to market
Lower logistics overhead
Improved document quality
Increased value of eCTD ready studies
Enhanced cooperation between clinical study and regulatory affairs departments
Efficient creation of clinical study
reports with RLPmanager - click to enlarge
Export clinical studies & submit them in any eSubmission management tool (including eCTDmanager)
RLPmanager enables users to compile and export files into one document in a format eligible for submission in eCTDmanager or any other electronic submission management tool. If you are using RLPmanager as an integrated solution to eCTDmanager, the study is created, compiled, finished, and versioned within RLPmanager. If required, the complete or partial study structure can be added to a submission by moving it from RLPmanager to eCTDmanager by drag-&-drop operation. When RLPmanager as a stand-alone solution, you can merge multiple PDF files into a single document. All reports that have been added to the study structure are compiled into one document and converted in paper or electronic format (PDF or ePaper).
Electronic outputs can be exported to the local file system or a Document Management System (DMS). The ePaper output is ready for use in any electronic submission management tool.
Study creation & publishing with RLPmanager
RLPmanager enables the automation of certain aspects in the process of creating and publishing a study. With RLPmanager offers Report Compilation Services for the automated creation of study structure and document assignment. While there are no pre-set study structures within RLPmanager, users can specify any kind of structure and save is as a template for reuse.
When creating a study with RLPmanager, the process of adding documents is significantly simplified - documents are added to the defined study structure from a report administration system or local file system by drag-&-drop or copy-&-paste operation. Once the structure has been implemented and all documents have been assigned, entire document sets or subsets can be published electronically or on paper. RLPmanager produces electronic outputs in both PDF and ePaper format. When publishing ePaper format, RLPmanager exports the created study in eCTD-ready PDF files. All documents contain hyperlinks, bookmarks and all PDF properties mandated by the eCTD standard, thus ensuring the study can be transferred to and used in any electronic submission management tool without conversion or further processing.
Additionally, RLPmanager provides a flexible creation of ToC, ToT and ToF. The Table of Contents will be created based on the existing document bookmarks. By using a customer specific XSL style sheet, it is possible to control the ToC entries individually.