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    Pharmceutical Company

Clinical Operations

n.a.

Employees

Team SCALA

2

Consultants

Time Period

8

Months

Developing a flexible and cross-functional Business Data Model in Clinical Operations

Starting Point

  • The IT landscape of Clinical Operations was characterized by many independent IT systems with overlapping functionalities, which accordingly also accessed or changed the same data.
  • In order to improve the IT landscape, the first step was to develop a common view of the data of the department.
  • For this purpose, a flexible and cross-functional business data model should be developed that can be easily understood and maintained by the business functions and can be used as a cross-functional communication platform for optimization.

Approach

  • Conducting a workshop and several Focus Interviews with experts to determine the requirements for the business data model.
  • Creating a concept to develop a cross-functional business data model for Clinical Operations, considering certain framework conditions (use of reference models, stepwise and flexible approach, reporting/evaluability).
  • Developing the business data model for Clinical Operations using Enterprise Architec.
    • Creating a high level framework with different data domains (business and common domains), using existing reference models.
    • Executing a “trial run” by transferring selected BPMN 2.0 processes to Enterprise Architect, identifying the relevant (business) data objects including linking them with the corresponding process steps as well as completing and modeling the data objects in the respective data domains.
    • Completing the cross-functional data model by merging the different domain models.
  • Creating reports on different information levels.
  • Creating a marketing slide deck to attract experts and business functions to join the data modeling initiative.

Deliverables/Benefits

  • Consistent and flexible data modeling approach allowing that the data model can be successively developed and completed across functions.
  • Flexible analysis and reporting options using integrated evaluation functions.
  • Proper platform to identify and derive strategic areas of improvement in the IT environement.

Further Project References

  • Developing a Process Model according to BPMN 2.0 Standard in Clinical Development22. March 2021 - 1:34
  • FT2E® (Analysis & Design) in the Corporate Communication Department (Interface: M&A/Corporate Finance)27. March 2021 - 10:59
  • Optimizing the Clinical Development Business Process Model and transfer to a web-based Solution20. March 2021 - 19:54
  • Analyzing Business Processes and IT Systems in the Global Medical Affairs Department22. March 2021 - 1:11
  • Managing a Program for the Implementation of an integrated Data Hub for Clinical Development21. March 2021 - 18:27
  • FT2E® (Analysis & Design) in the Regulatory Affairs Department of a French Subsidiary22. March 2021 - 1:14

Our office in Cologne

SCALA Management Consulting GmbH & Co KG
EuroNova III
Zollstockgürtel 61
D-50969 Köln
n: +49 (0)221 / 27 64 59 82
x: +49 (0)221 / 27 64 59 83

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LAST PROJECTS

  • Developing a Process Model according to BPMN 2.0 Standard in Clinical Development22. March 2021 - 1:34
  • Developing a flexible and cross-functional Business Data Model in Clinical Operations20. March 2021 - 19:58
  • FT2E® (Analysis & Design) in the Corporate Communication Department (Interface: M&A/Corporate Finance)27. March 2021 - 10:59

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