Developing a complete process framework for a midsized client

A leading global healthcare company working with the science and medicine of pulmonary arterial hypertension had grown over the last 10 years and needed help aligning their framework.

The client’s business had rapidly expanded over the last ten years and was now facing the challenge of a fragmented and cumbersome SOP landscape with no overall structure. They needed to develop a new optimized and aligned framework that was scaled to match the pharmaceutical company they had grown into.


When HERAX was contacted by the client, the Clinical Development organization had a clear need for process alignment and optimization across departments and geography to ensure consistent processes, knowledge sharing and expertise preservation.

Through interviews and workshops, HERAX performed an in-depth analysis of both cross-functional and departmental processes all across Clinical Development. The new SOP framework was created from the analysis of the existing processes and quality documentation, eliminating redundant and overlapping processes and closing gaps arisen during the rapid company growth.

HERAX wrote the SOPs and scopes for all SOPs in the new framework and linked them to associated quality documents, departments, roles and IT structure.

The deliverables covered in-depth process analysis for all departments in clinical development, a complete quality document framework including scope, dependencies, SOP governance procedure and the development of high-level SOPs.

I loved working with HERAX as their consultants were always professional and knowledgeable. Their involvement in the project was a considerable improvement over the way we used to do it.”
– Head of Clinical Operations
Realized benefits

The client realized many benefits from the help provided by HERAX. Among the measurable benefits are: 

  • Complete and clear overview of SOPs, dependencies, and associated roles
  • Organizational Change Management was a part of the project from the start leaving the business with a clear understanding of specific changes for each role and benefits (i.e. “What’s in it for me?”)
  • Updated, structured and easy to follow SOPs and supportive documentation – increased effectiveness and better use of clinical resources
  • Enabling true global collaboration across R&D both across departments and geography
  • New processes were developed to standardize across systems and harmonize the interdisciplinary business processes from clinical to IT

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If you want to hear more about the development of a SOP framework, increasing global collaboration and optimizing processes all across Clinical Development, then please contact us.

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