A global pharma company in Europe needed a SCE to support their growing Biometrics team. The new system should ensure global accessibility, simple versioning, audit trial, and lean statistical programming processes.
Problem
The client was struggling with local versions of statistical programming tools making it difficult for the IT department to manage and support. The statistical programmers experienced slow connectivity to data which resulted in local copies of programs and datasets. Cumbersome manual processes for data access and audit trail was a challenge for ensuring inspection readiness.
Solution
HERAX helped the client select a vendor from a number of different SCE providers with the use of HERAX vendor selection methodology. The vendor selection included user requirement specification, use cases and negotiation with vendors to achieve the best outcome from the selection.
After selecting the vendor, the SCE solution was implemented with project management from HERAX, utilizing our agile methodology together with Line of Business, IT and the vendor. The agile approach ensured quick delivery of critical functionality and alignment with the business processes.
New IT processes were developed to ensure efficient collaboration between the client’s IT department and the vendor. Statistical programming processes were created or updated to support a lean use of the new solution.
Demos and solution information were shared during the project as part of the Organizational Change Management and efficient training planning ensured a successful roll-out.
“This implementation is an example of what fit for purpose is about. It was straight forward and smooth, the team knew what they needed and worked hard until the end.”
– Head of Biometrics
Realized benefits
The solution was implemented in 6 months from idea to go-live.
- A centralized, cloud based SCE platform ensures global access to statistical programming tools and a single repository for clinical data
- An efficient system design reduced the need for SAS server cores with 75%
- Clear traceability to output programs used for regulatory submissions is established through version control
- Audit trail logs on access, programs and data provides documentation for inspections
- Availability of widely used statistical programming tools and limited system restrictions ensures efficient processes and provides the ability to adjust and optimize the way of working
