Main Components

The eCTD Integral Information System with its Main Components is a system that contains all the structural and narrative data related to the business functions it covers.

The most important characteristics of the Main Components are as follows:

  • Corporate Entities of the corporation are the center of activity of any Pharmaceutical Corporation. Their creation and their changes are realized through various types of Corporate Projects and are the main focus of attention of corporate management and the main subject of involvement of corporate professionals.
  • Corporate Projects of the corporation have as their object one or more Corporate Entities whose creation or change they bring about.
  • Enriched Email is the main integrating factor of the system, linking everything together and enabling integration of the data into the eCTD Integral Information System.
  • Corporate Documents and Corporate Documentation Cloud where all documents generated during the Corporate Entity creation/change definition process and realization of Corporate Projects are stored
  • eCTD Integral Information System Database is the place where all structural data of the Corporate Entities, all correspondence related to Corporate Entities and the realization of Corporate Projects, and links to documents generated during the creation/change of Corporate Entities and the realization of Corporate Projects are stored.

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The most important component of the eCTD Integral Information System for the Pharmaceutical Corporation are Corporate Entities.

The Corporate Entities and their creation and development/changes are defined using structured data which are stored in the eCTD Integral Information System Database, and documents with narrative and/or multimedia data which are stored on the Company Documentation Cloud of the corporation. Links between Corporate Entities and corresponding narrative entity definition documents are stored in the eCTD Integral Information System Database.
Each creation or development/change of a Corporate Entity is registered in the eCTD Integral Information System with the unique core sequence and all subsequent activities related to the structural and narrative definition of this new Corporate Entity or its development/change are related to that core sequence.

Further reporting of the creation or development/change of a Corporate Entity to the Health Authorities and subsequent introduction of a new or developed/changed Corporate Entity to the Corporate Markets are also registered in the eCTD Integral Information System with the new core sequences and realized with separate Corporate Projects.

The use of entity structural definition data enables the automatic generation of various XML documents, among other things, the automatic generation of various electronic Application Forms (eAFs) as part of the initial submissions for the realization of Corporate Projects.

The use of entity definition documents enables the automatic generation of various initial and related submissions for the realization of Corporate Projects.

A more detailed description of this component of the eCTD Integral Information System is given here.

A Project is a collaborative effort that is planned and conducted to achieve a particular aim.

When it comes to the pharmaceutical corporate environment, each Corporate Project is related to a specific Corporate Entity with the aim to create a new one or to improve and further develop an existing one and introduce those changes to the Health Authorities and Corporate Markets.

Each Corporate Project is also registered in the eCTD Integral Information System with the unique core sequence.

For the Pharmaceutical Corporation, the most important entity is Active Substance and therefore most projects in this type of corporations are associated with that Corporate Entity.

Due to the highly legislatively regulated environment  where those Corporate Projects are conducted all of them can be standardized using legislative elements such as predefined activities, milestones, and significant events. Typical examples of those Corporate Projects are:

  • Conduct of a Pre-Clinical Tests
  • Authorization of a Clinical Study
  • Realization of a Clinical Study
  • Clinical Study Variation type FDA/NCA
  • Medicinal Product Marketing Authorization Application - decentralized procedure
  • Medicinal Product Marketing Authorization Application - national procedure
  • Medicinal Product Variation IB
  • Medicinal Product Variation type II
  • etc.

For most of those Corporate Projects,  legislatively predefined duration of activities are also set which makes the process of standardization even more straightforward.

A more detailed description of this component of the eCTD Integral Information System is given here.

Practically all activities in a modern corporation are recorded in email messages, regardless of whether they are related to a Corporate Entity or a Corporate Project and regardless of their internal or external nature.

In an attempt to integrate all these activities and record them into the eCTD Integral Information System the Enriched Email was developed as an integrating factor of the whole system. To fulfill such an ambitious role, the Enriched Email constantly and simultaneously communicate with three different servers:

  • Classical Email Server
  • Documentation Server
  • Relational Database Server

In this way, complete monitoring of the creation/changes of Corporate Entities and the realization of Corporate  Projects is enabled without any new burden for end-users and with true "real-time" insight.

The Enriched Email consists of two components:

  • Relational Email Server - consisting of the email procedures stored in the relational database of the eCTD Integral Information System and constantly communicating with a Classical Email Server
  • Enriched Email Client - an end-user client interface constantly communicating with the Relational Email Server and the Corporate Documentation Cloud

Relational Email Server

The Relational Email Server's email procedures are based on the Java email engine software. They constantly communicate with the classical corporate email server and record all its changes in the Enriched Email section of the eCTD Integral Information System.

Changes to the classical corporate email server are made by:

  • Health Authorities and Corporate Business Partners with incoming email messages
    or
  • corporate professionals
    • using the Enriched Email Client 
      or
    • using mobile devices during their mobile correspondence

All recorded changes are processed:

  • automatically by the Relational Email Server using various business rules
    or
  • manually by the corporate professionals with the Enriched Email Client using data on Corporate Entities and Corporate Projects

Having the Relational Email Server and all Corporate Entities and Corporate Projects data in the same relational database creates the basis for the eCTD Integral Information System structure, providing numerous capabilities unique to Integral Information Systems. 

Enriched Email Client

The Enriched Email Client contains all the features of a regular email client such as:

  • Recipients (To, Cc, Bcc)
  • Subject
  • Text
  • Attachments
  • Reply message
  • Forwarded message

plus additional features, namely:

  • Theme
  • Topic Class - theme dependent topic classes
  • Topic - topic class dependent topics
  • Subtopic - Corporate Entity dependent subtopics 
  • Activities and Significant Events - Corporate Project dependent activities and significant events
  • Assistants
  • Agents
  • Followers of topic correspondence
  • Subsequent processing of mobile correspondence
  • Initiating of correspondence - initiating registered email message of correspondence
  • Attachment processing - classifying and linking attachments to registered email topic and sub-topic/significant event 
  • Automatic upload of the processed attachments to the Corporate Documentation Cloud
  • Corporate Documentation Cloud search for corporate documents and automatic download and attachment of documents to the registered email message
  • Confidentiality
  • Completeness
  • Pointing
  • Selection
  • etc.

All structured data of each enriched email message are stored in the eCTD Integral Information System Database while all new attached documents are classified, linked to a Corporate Entity or Corporate Project, and automatically uploaded to the Corporate Documentation Cloud while saving links in the relational database.

The Enriched Email allows the presentation of correspondence related to a specific topic and subtopic or activity/significant event from multiple corporate correspondents, together with all accompanying attachments.

The Enriched Email Client, as an interactive tool, also provides a real-time experience to managers and end-users through the use of associated reviews and reports.

With the help of the Enriched Email with these additional features, it is possible to fully monitor the creation and development of Corporate Entities and monitor the activities of related Corporate Projects.

A more detailed description of this component of the eCTD Integral Information System is given here.

Corporate Documentation consists of:

  • corporate correspondence
  • corporate documents

All corporate correspondence is stored in Enriched Email section of the eCTD Integral Information System.

All corporate documents are stored on the Corporate Documentation Cloud. They can either be uploaded manually using the appropriate application forms or automatically when sending /receiving them as attachments to corporate correspondence with external or internal enriched email messages.

Several types of corporate documents are recognized:

  • Corporate Entity related
    • basis for entity creation documents
    • entity definition documents
    • basis for entity change documents
    • entity change definition documents
    • documents generated during the functional activities related to Corporate Entities
  • Regulatory Project related
    • initial submission documents
    • related submission documents
    • documents generated during the realization of Corporate Projects

    All documents are uploaded to the Corporate Documentation Cloud and can be easily searched, accessed and downloaded either:

    • separately, found by searching using document classification and their relations to the Corporate Entities and Corporate Projects
      or
    • as a collection/selection of files using document selection template, such as eCTD submission  templates as a gathering/collection tool 

    A detailed description of this component of the eCTD Integral Information System is given here.

    eCTD Integral Information System Database

    The database of the eCTD Integral Information System is based on the "Oracle" relational database.

    All structural data of the Corporate Entities and the Corporate Projects as well as their relations with each other, together with links to the relevant documents residing in the Corporate Documentation Cloud are stored in the relational database of the eCTD Integral Information System making it possible due to the integrity of the system to:

    • Rely on a single point for data entry and exchange throughout the corporation
    • Enter each part of the structural data only once
    • Provide assistance and control in the performance of business processes
    • Generate comprehensive reviews and reports for Management and corporate professionals

    Data is entered into the eCTD Integral Information System interactively during the performance of business processes and therefore all data is in real "real time", making reviews and reports as timely as possible.

    An indication of how complete the structural data is in the database is the ability of the eCTD Integral Information System to generate automatically instead of manually:

    •  various submissions of documents to Health Authorities and other Business Partners
    • electronic Application Form (eAF) and other xml documents using only the data from the database
    • Corporate Entity related reviews and reports such as Manufacturing Flow Charts, Entity Creation Correspondence Chain, Entity Subtopic Correspondence etc.
    • Corporate Project related reviews and reports such as Projects Correspondence Chain, Project eCTD Requests etc.
    • automatic initiation of Variations in all relevant Dossiers based on the "basis for change" documents
    • etc.

    The Relational Email Server's procedures based on the Java email engine also reside in the eCTD Integral Information System Database continuously communicating with the classical corporate email server.

    All data contained in regular email messages are stored in the eCTD Integral Information System Database together with the additional Enriched Email processing data.