Realization of Corporate Projects

  • Preparation for a Project Initial Submission  

    • Completion of a project initial submission

    • Technical validation and submission of a project initial submission

  • Implementation of a Corporate Project

    • Beginning of the Implementation

    • Project related submissions

    • Project correspondence chain

  • Closing of a Corporate Project

The realization of each Corporate Project consists of:

Preparation for a Project Initial Submission

Realization begins with the project activity "Initial Submission Preparation" when the project initial submission is created. The project initial submission is the documentary basis for the implementation of the Corporate Project and its completeness is the main prerequisite for the beginning of project implementation.

Both, corporate entity persons and corporate project persons are engaged in the project initial submission preparation, while the coordination role is assigned to corporate project persons.

Tools like:

  • internal payment Request
  • internal info Request
  • internal submission eCTD Request

are available to corporate project persons to arrange payments, gather additional information, and request additional documentation related to the Corporate Entities present in the initial submission.

Implementation of a Corporate Project

The project implementation begins with the submission of the project initial submission to the Health Authorities and/or other Business Partners. 

The Implementation of the Corporate Project is accomplished through a series of interrelated project activities with project milestones and crossroads leading to project Closing. During the implementation of a  Corporate Project, several project related submissions may be prepared and submitted to Health Authorities and/or other Business Partners.

To perform all tasks related to the creation of project related submissions, the following tools are available to corporate project persons:

  • internal info Request
  • internal submission eCTD Request (Internal Entity Definition Request)
  • internal editorial eCTD Request (Internal Entity Editorial Request)

It is important to note that "internal submission eCTD Requests" and "internal editorial eCTD Requests" generate a "work order" for a designated corporate entity person responsible for the creation of submission documents or the editorial changes to existing entity definition documents. A designated person's Agent and Assistant are also included in the scenario with the same rights and responsibilities. 

Closing of a Corporate Project

The Closing consists of receiving or generating the project entity documents that define the results of the Corporate Project and their interpretation.

For example, the Marketing Authorization results from the Marketing Authorization Application Project and is received from the Health Authorities. 

Another example is a Clinical Trial Report that results from a Clinical Trial Realization Project and is prepared by a clinical entity person.

To demonstrate the approach used to conduct Corporate Projects a detailed presentation of the Authorization Project and the Realization Project of the Clinical Trial, being the most complex scenario, is presented here.

The same approach is used for other classes of Corporate Projects:

  • Pre-Clinical Tests Projects

  • Medicinal Product Projects

  • Marketing Campaign Projects

Also, a similar approach can be extended to other business areas upon request.

Preparation for a Project Initial Submission

Preparation for a project initial submission is performed in two steps:

  • Completion of a project initial submission documents

    • project submission documents

    • entity definition/change documents

    • project entity documents

  • Technical validation and submission of the project initial submission

    • Downloading of the initial submission

    • Generation of the eCTD format files

    • Technical validation of the initial submission

    • Submission of the initial submission

Completion of a project initial submission

After the receipt of an automatic enriched email notification about the Corporate Project launch, the corporate project person checks the status of the narrative entity definition/change documents related to the Corporate Entities present in a project initial submission.

Each project initial submission consists of:

  • project entity documents - documents that describe the result of a previous Corporate Projects and are created during the closure of previous projects
  • modularly assembled entity definition/change documents - documents that can be created in advance, before the project initiation and can be used in many initial submissions of different classes/types of Corporate Projects
  • project submission documents - documents that cannot be created in advance, can be created only during the project launch preparation activity, and can be used only once for the realization of that particular Corporate Project

Project entity documents

Project entity documents describe the result of previous Corporate Projects and are created during the closure of previous projects.

They are selected during the compilation of the project initial submission using the business rules incorporated in the eCTD Integral Information System.

During the preparation of project initial submission, no interventions are necessary regarding this type of document.

Entity definition/change documents

Since the complete narrative definition is not a prerequisite for a Corporate Entity to be a part of a project initial submission, some narrative entity definition documents may not be uploaded at the time the initial submission is created. To review the status of the narrative definition of Corporate Entities present in the initial submission, the application form "Projects/Upload Submission Documents" can be used. 

For each entity definition/change document the responsible corporate entity person is displayed.

Contacts via Enriched Email can be used to prioritize the process of narrative definition of Corporate Entities present in the project initial submission.

Project submission documents

During completion of a project initial submission, corporate project person(s) should pre-discuss the application with the Health Authority(s), validate the proposed project type, project implementation time-line and initiate adjustments and corrections if necessary.

The main task for the corporate project person is to create and upload project submission documents of the project.

The Internal payment Request(s) sent by Enriched Email to the corporate finance person  is used to obtain proof of payment documents if required.

If necessary, internal info Requests can be generated to gather additional information and complete the project initial submission.

In case a corporate project person needs assistance to create some submission documents, he can engage corporate entity person(s) by issuing internal submission eCTD Request(s).

Each internal submission eCTD Request generates a "work order" for the designated corporate entity person. 

The corporate entity person, his Agent and/or his Assistant are notified of the Request via enriched email messages. Each corporate entity person can find its internal submission eCTD Requests on the application form "Projects/Upload Submission Documents".

All internal submission eCTD Requests result in a corporate entity person uploading one or more new entity definition documents to the Corporate Documentation Cloud. When the completion of the entity definition documents upload is declared, an automatically generated enriched email notification is sent to the corporate project person request initiator.

On the application form "Projects/Upload Submission Documents", at the end of each session, the completeness of the current project initial submission is automatically checked. When all entity definition documents and project initial submission documents are uploaded and all internal submission eCTD Requests declared completed, project initial submission is ready for the next step, technical validation. The "status" of the initial submission is automatically changed to "ready for technical validation" and it can be selected on the application form "Projects/Initial submission technical validation".

Technical validation and submission of a project initial submission

The technical validation of the project initial submission consists of four steps:

  • Downloading of a project initial submission
  • Generation of the eCTD initial submission format files
    required only for Medicinal Product(s) Corporate Projects
    • index.xml,
    • index-md5.txt, and
    • eu-regional.xml
  • Technical validation of a project initial submission
    required only for Medicinal Product(s) Corporate Projects
    • generation of initial submission validation file
  • Submission of a project initial submission
    • sending via Enriched Email to Health Authorities and/or Business Partners
      or
    • uploading to the Health Authorities portal

Downloading of a project initial submission

Completed project initial submissions can be selected on the application form "Projects/Initial submission technical validation".

By clicking on the "Download Submission" button, the  project initial submission is automatically downloaded to the local Work Station at a predefined location.

Generation of the eCTD format files

For Medicinal Product(s) Corporate Projects only, additional files index.xml, index-md5.txt, and eu-regional.xml have to be created to generate the eCTD initial submission format files. Those files can be created using the free application "indexer" or any other similar application.

Any format changes can be easily implemented to comply with the new Health Authorities requirements.

Technical validation

Only for Medicinal Product(s) Corporate Projects and after the generation of the eCTD initial submission format files, using the free application "BfArM eValidator" or any other similar application technical validation can be done.

If necessary, additional or changed submission documents can be uploaded and process of submission download, creation of indexer files and technical validation repeated.

At the end of the process, validated files index.xml, index-md5.txt and eu-regional.xml have to be uploaded using the application form "Projects/upload submission documents".

Submission of a project's initial submission 

After compression, the project's initial submission is delivered to the Health Authorities and/or other Health Institutions and Business Partners by posting it on their websites or sending it as an attachment via a enriched email message.

Implementation of a Corporate Project

In general, the implementation of a Corporate Project consists of the implementation of interrelated project activities that lead to the completion of the Corporate Project and its sub-projects.

Following principles are implemented:

  • Significant events are defined for each project activity.
  • Certain significant events initiate sub-projects
  • Each significant event produces a corporate project document that the corporate project person sends or receives as an attachment to a enriched email message.
  • Each project activity ends with a project milestone, which in itself is also a significant event.
  • The end of one project activity leads to the next, but the end of an activity can also be a crossroad for the several subsequent project activities
  • Depending on the outcome of the current project activity and the corresponding significant event, the subsequent project activity is determined and the next project activity initiated

During the processing of enriched email messages, for each project activity, and depending on whether it is the processing of outgoing or incoming email, significant events that may occur during the project activity implementation are displayed. By selecting one of them, the progress of the Corporate Project implementation is automatically updated in the eCTD Integral Information System.

Also, for each significant event, related project document classes that can be found as attachments to enriched email messages are displayed during the classification and identification of attachments.

It is important to note that when using excel share points or similar systems, corporate project persons have two or even more interactions with the "system " per one business interaction. The first interaction with the email server, when receiving or sending related enriched email messages, and the next interaction(s), latter when they find it convenient, when entering data in one or more excel share points. The consequences of such a method are obvious.

Beginning of the Implementation

The start of the implementation of the Corporate Project is marked by the submission of a project initial submission to the Health Authorities and/or other Health Institutions or Business Partners.

The project initial submission documents are compressed and either uploaded to the Health Authorities' web portals or sent as an attachment via a enriched email message to other Health Institutions or Business Partners.

Corporate Project sub-projects

Certain types of Corporate Projects may consist of several sub-projects, for example, a Clinical Trial Project consists of an Authorization Project and a Realization Project. Furthermore, sub-projects such as Clinical Trial Monitoring and SAE/SAR/SUSAR are regularly implemented during the Clinical Trial Realization Project.

Project related submissions

During the implementation of the Corporate Project, several project related submissions can take place, which are always marked by a project milestone, the end of the current project activity, and the beginning of the next project activity.

To create project related submissions, corporate project persons have two powerful Enriched Email Client tools at their disposal:

  • internal submission eCTD Request
  • internal editorial eCTD Request

For the assistance in the preparation of related submission documents, the corporate project person can issue internal submission eCTD Request(s) to the corporate entity persons.

For the editorial changes of the submitted entity definition documents, the corporate project person can issue internal editorial eCTD Request(s) to the designated corporate entity persons.

The current project activity cannot be completed unless all eCTD Requests are declared completed by the designated corporate entity persons.

The cessation of data collection represents the end of the project implementation and the beginning of the last activity on the project realization, "Closing of a Corporate Project".

Project correspondence chain

During the Implementation of a Corporate Project all significant events are created using enriched email messages/notifications. The project correspondence chain is created which can be used by all corporate project persons and corporate managers. Functionality of the project correspondence chain is fully explained in the "Enriched Email" section of this site here.

It is important to note that during the implementation of a Corporate Project, the Enriched Email Client constantly communicates with the Relational Email Server and the Corporate Documentation Cloud, while the Relational Email Server communicates with the Classical Email Server, providing all together consistent data and a real-time experience.

It is important to note that only one corporate project person's interaction with the "system" is required for each business process, thus eliminating data inconsistencies, increasing the efficiency of corporate project persons, and enabling corporate managers to monitor the progress of the Corporate Project in real-time and intervene promptly if necessary.

Detailed presentation of each class/type of Corporate Projects with project activities, mutual interconnections of project activities, milestones, significant events, and corporate documents is presented here.

Closing of a Corporate Project

The Closing represents the last project activity of the Corporate Project's realization.

After the project's implementation, a set of final project entity documents is generated or received to define the results of the Corporate Project.

The final project entity documents are related to both: Corporate Entity and Corporate Project. Typical examples are documents generated after the project implementation of a Clinical Trial when the clinical trial report and several other documents are generated by clinical entity persons. 

The marketing authorization for a Medicinal Product received from Health Authorities represents another example of a project entity document.

The project entity documents generated by the corporate entity persons, such as pre-clinical tests reports and clinical trial reports, are manually uploaded by the corporate entity persons, while the project entity documents received from the Health Authorities are automatically uploaded when received by corporate project persons and processed by Enriched Email.

After Closing, the Corporate Project changes its status to "completed" and is no longer displayed on the active project LoVs, especially on the list of topics in the Enriched Email Client.