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Clinical Development

n.a.

Employees

Team SCALA

2

Consultants

Time Period

5

Months

Optimizing the Clinical Development Business Process Model and transfer to a web-based Solution

Starting Point

  • The customer started a project to update and align the process model of clinical development to the recently reorganized structures.
  • For this purpose, the procedural, functional and organizational changes had to be transferred into the current process model.
  • In addition, the process model was to be transferred into a more comprehensive IT tool that allows intuitive navigation and can be accessed by employees worldwide.

Approach

  • Reviewing and optimizing Clinical Development processes, considering regulatory requirements.
  • Documenting the optimized core processes on four levels (process landscape, main processes, sub-processes, description of activities).
  • Supporting the transfer of the process documentation to the group-wide content management system, including ensuring the navigation between the various description levels and linking to important appendices (standard operating procedures, work instructions, role profiles, checklists, templates).

Deliverables/Benefits

  • Optimized Clinical Development processes that also meet current regulatory requirements.
  • Clear, web-based and fully navigable process model of Clinical Development on four description levels.
  • Worldwide availability of the process flows including the essential supporting documents.

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
  • 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
  • Planning, managing and monitoring a Hardware and Software Roll-out for Fund Services & Private Banking22. March 2021 - 1:14
  • Computer System Validation of an „Adverse Event Reporting Tool“ for Pharmacovigilance22. March 2021 - 1:15

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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Link to: Transforming Standard Operating Procedures (SOP’s) of Regulatory Affairs into Process Flows according to BPMN 2.0 Standard Link to: Transforming Standard Operating Procedures (SOP’s) of Regulatory Affairs into Process Flows according to BPMN 2.0 Standard Transforming Standard Operating Procedures (SOP’s) of Regulatory Affairs...
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