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.

Benefits

  • Maximum flexibility in study creation
  • Reduced approval times and time to market
  • Reduced paper
  • Lower logistics overhead
  • Cost-efficient
  • 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.

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RLPmanager Product Information

eSubmission, eCTD and RPS Process Services

In order to maximize profitability, modern pharmaceutical organizations need to be able to register products as quickly as possible whilst ensuring compliance with a variety of global regulations. With the high costs associated preparing regulatory submissions it is essential that the compilation and publishing processes are fully optimized. EXTEDO can help you with this.

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Technical Consulting

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.

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Education & Training Services

To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOsuite solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.

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