Corporate Projects

  • Classes/Types and Dossiers

    • Classes and Types of Corporate Projects

    • Dossiers of Corporate Projects

  • Corporate Project Persons

    • pre-clinical project person

    • clinical project person

    • regulatory project person

    • marketing project person

Due to the highly legislatively regulated environment in which Pharmaceutical Corporation regulatory projects are conducted, most projects can be classified, standardized and kept in four types of Project Dossiers.

All classes of Corporate Projects have as a common denominator an Active Substance that appears in various forms such as:

  • Marketed Substance used in Pre-Clinical Tests Projects
  • Investigational Medicinal Product used in Clinical Trials Projects
  • Medicinal Product used in Corporate Projects
  • Marketed Medicinal Product used in Marketing Projects

For each class of Corporate Projects, standardized projects are created with predefined sub-projects and project activities with milestones, and significant events. The interrelationships between project activities are also defined on the basis of legislative regulation and/or business rules. The standardized Corporate Projects for all four classes are listed here.

The beginning and end of each project activity is marked by a milestone which is significant event in the realization of a Corporate Project. Also, for each project activity, a number of other significant events that occur during its realization are pre-defined and serve as an important tool in monitoring the progress of Corporate Projects realization. Every milestone and significant event are accompanied by a corresponding corporate project document(s).

The regulatory environment in which Corporate Projects are conducted is such that their whole realization is carried out using internal and external email correspondence between various corporative participants, Health Authorities, Health Institutions and other Business Partners.  

Due to the Enriched Email where all project activities are recorded, either manually, by registering incoming regular email messages and writing enriched email messages, or automatically, by the generation of enriched email notifications, real “real-time” insight into the Corporate Project realization is achieved.

Using the project correspondence chain, where all correspondence related to a specific Corporate Project is interconnected, regardless of the number of participants, corporate managers and direct participants are able to monitor the project and act in a timely manner to achieve a successful project outcome. 

Managerial insight into the realization of a Corporate Project can be achieved ad hoc at will or continuously using "following by choice", one of the features of Enriched Email.

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It is important to note that corporate project participants can see, using reviews of eCTD Integral Information System and depending on their system privileges, all enriched emails generated during the realization of a Corporate Project, even enriched emails in which they did not participate. The same applies to corporate managers who can see the complete correspondence without being correspondents in any of the enriched emails.

Corporate Projects - Classes/Types and Dossiers

Taking into account phases in the development of an Active Substance, which is the most complex scenario present in a Pharmaceutical Corporation, four classes of Corporate Projects are supported for each Active Substance in the eCTD Integral Information System. 

The four classes of Corporate Projects are:

  • Pre-Clinical Tests Projects
  • Clinical Trial Projects
  • Medicinal Product(s) Regulatory Projects
  • Medicinal Product(s) Marketing Projects

Also, a special type of Corporate Entity, a Dossier, is introduced, where data on Corporate Projects are stored. For the four classes of Corporate Projects following four classes of Dossiers are formed for each Active Substance :

  • Pre-Clinical Tests Dossier
    for each Active Substance globally
  • Clinical  Trials Dossier
    for each Active Substance and State/Country
  • Medicinal Products Regulatory Dossier
    for each Active Substance and State/Country/Federation
  • Medicinal Product Marketing Dossier
    for each Active Substance and State/Country/Federation

Classes and Types of Corporate Projects

Within each class of Corporate Projects, several project types are defined, with the exception of Pre-Clinical Tests Projects where there is only one type. The detailed specification of Corporate Projects is presented here.

Each class/type of Corporate Projects follows the general business rules present in the eCTD regulatory environment that can be additionally adapted to any specific corporate needs.

The Corporate Projects are conducted through a series of interrelated project activities with project milestones, project significant events and intersections leading to project Closing.

Each class/type of Authorization Projects is initiated by a managerial decision, and after a successful authorization, a corresponding Realization Project follows.

Dossiers of Corporate Projects

The Dossier for a given Active Substance and a project class is automatically formed when the first Corporate Project of that class is launched. All subsequent Corporate Projects of that Active Substance and that project class are stored there. Models of typical Corporate Projects have been designed and standardized for each class of projects.

For instance, at the beginning of a Clinical Trial Authorization Project of an Active Substance, when making project initial submissions to Ethics Committees and Health Authorities, some of the previously generated documents from the Pre-Clinical Tests Dossier of the same Active Substance will be automatically included in the specified directory paths for this type of project initial submissions.

Also, at the beginning of the Marketing Authorization Application Project, when making the project initial submission to the Health Authority, some of the documents from both, the Pre-Clinical Tests Dossier and the Clinical Trials Dossier, will be automatically included in the specified directory paths for this type of project initial submissions. The selections of documents depends on the business rules implemented in the eCTD Integral Information System.

It is important to note that the Active Substance as a common entity and denominator links the different types of Dossiers together so that all entity definition documents can be used to create project initial submissions. The directory tree and documents depend on the type of project initial submission template, but due to the modular nature of the Integral Information System,  the same documents are used in different types of project initial submissions. 

In the eCTD Integral Information System, each project/sub-project is assigned a core sequence and the realization is tracked using the nomenclature of the electronic Central Technical Document (eCTD). Therefore, the first initial submission in a Dossier has the sequence number "0000" and so on. 

The creation of all types of Dossiers is described in full detail in the Corporate Entity creation section of this site here. 

Corporate Projects - Corporate Project Persons

There are four types of corporate project  persons, namely:

  • pre-clinical project person

  • clinical project person

  • regulatory project person

  • marketing project person

Corporate project persons are corporate employees responsible for the realization of Corporate Projects through interaction with corporate entity persons, other Corporate Projects, Health Authorities and other Business Partners who participate in the Corporate Project realization.

At the initiation of a Corporate Project, depending on the Corporate Project class, corresponding corporate project persons are designated.

Also, these persons are automatically granted the system privileges necessary to perform these duties, including becoming "designated followers" of all enriched email correspondence related to the Corporate Project for which they are designated. 

They, their Assistants and their Agents are the only persons who can create and upload initial/related project submission documents, initiate internal payment Requests, internal submission eCTD Requests, internal editorial eCTD Requests, and internal Info Requests and communicate and submit documents to Health Authorities and other Business Partners for the Corporate Project they are designated. 

All designated corporate project persons are informed of their assignment via automatically generated enriched email notifications.