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eCTD Integral Information System for Pharmaceutical Corporation

Business Functions supported by the eCTD Integral Information System (IIS)

Main Principles incorporated in the eCTD Integral Information System (IIS)

Main Components of the eCTD Integral Information System (IIS)

The business environment of the Pharmaceutical Corporation is where the introduction and ongoing development of Corporate Entities and the realization of Corporate Projects take place. 

Introduction/Development of Corporate Entities and realization of Corporate Projects is achieved through complex activities which in turn generate considerable correspondence among participants and numerous documentation.

The Enriched Email is developed to integrate all those activities and deal with such an extensive amount of correspondence and the exchange of documentation.

To handle documentation, Corporate Documentation Cloud is introduced where all documents are kept. All document are linked with either Corporate Entity or Corporate Project and are classified with respect to parallel system of classification and identification.  

As an optimal tool for coping with such a complex environment, the eCTD Integral Information System is developed using Corporate Entities, Corporate Projects, Corporate Documentation Cloud, and Enriched Email as its cornerstones. 

The eCTD Integral Information System is the only "share point" that corporative employees need to communicate with in their day-to-day activities and that corporate managers should rely on to obtain the assistance, reviews and reports necessary for successful corporate operation and governance.

The eCTD Integral Information System provides many features such as real “real-time” operation, great reduction and simplification of manual and repeatable tasks, assistance to the users while performing those tasks, sophisticated level of control and prevention of mistakes, many automated features, and powerful reporting and review capabilities to name just a few of the most important.

No matter how ambitious and challenging the task of designing such a system was, we embarked on this path many years ago, and using our experience and professional skills, we have come up with a system that provides all of the above and many more features.

Business Functions supported by the eCTD Integral Information System (IIS)

eCTD Integral Information System is dedicated to the following business functions of the Pharmaceutical Corporation:

  • Pre-Clinical business function
  • Clinical business function
  • Quality business function
  • Chemical, Manufacturing and Control business function
  • Regulatory business function
  • Marketing business function

Also, upon request, additional business functions with their disciplines and sub-disciplines can also be incorporated.

Corporate managers and professionals involved in these business functions should meet all their business needs by interacting with this eCTD Integral Information System.

Numerous highly legislatively regulated interactions with Health Authorities and other Health Institutions are present in the domain of these business functions. Those regulatory business rules make the design and further development of systems like this more demanding, but at the same time more straightforward and we tried to utilize this fact as much as possible.

Main Principles incorporated in the eCTD Integral Information System (IIS)

Following principles and guidelines were followed from the very beginning of the designing and developing of eCTD Integral Information System:

  • The system must be in real “real-time”

For the system to be in real "real time", the system can not rely on corporate employees to, in the aftermath of their regular activities, log on to various "share points" and enter previously generated data at their convenience. Corporate employees must have at their disposal interactive system to perform their regular business activities, create relevant data, and at the same time enter those data in the eCTD Integral Information System. 

  • All legislative and corporate business rules should be incorporated in the system whenever possible

This approach assists corporate employees when performing their activities and prevents costly errors. Business rules must be incorporated into the system and applied when data is generated during the interactive communication of corporate employees with the system.

Additional business rules specific to a particular Pharmaceutical Corporation can be easily incorporated into the eCTD Integral Information System upon request.

  • Interaction with the Integral Information System must be simple and efficient for end users, regardless of the cost and complexity of the developer's work.

Successful implementation of such an eCTD Integral Information System requires simplicity when it comes to end-users.

  • Data must be entered only once into the system by a designated person, his Assistant, or his Agent and can be used by others whenever needed in accordance with the system rules and end-user privileges.

The efficiency and effectiveness of end-users and the integrity of the eCTD Integral Information System were the primary goals.

  • Data changes can only be made by a designated person, his Assistant, or his Agent with the required system privileges based on an appropriate managerial decision or the action of external factors. 

Managing change in a complex information system like this is of the utmost importance. Each change should be introduced only once and it should be immediately propagated throughout the whole system.

In order to incorporate above stated principles Main Components of the eCTD Integral Information System were developed and established, namely:

  • Corporate Entities - classified in thirteen hierarchical levels with:

    1. Structural definition/change data
    2. Narrative definition/change documents

  • Corporate Projects - classified and kept in four classes of project dossiers:

    1. Pre-Clinical Tests Dossiers
    2. Clinical Trial Dossiers
    3. Medicinal Product Dossiers
    4. Marketing Campaigns Dossiers

  • Enriched email - with additional features such as:

    1. Topics - entities or projects

    2. Subtopics - depending on the entity class

    3. Activities with significant events and milestones - depending on the project type

    4. Processing and classification of documents attached to enriched email messages
    5. Designated follower
    6. Agents
    7. Assistants
    8. Followers by choice

  • eCTD Integral Information System Database - where all structural data of:

    1. Corporate Entities

    2. Corporate Projects

    3. Corporate Correspondence related to Corporate Entities and Corporate Projects

    4. Links to Corporate Documents

are stored.

The Main Components are described in more detail here.