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Biosimilar Case Study

The following case study had been realised between November 2011 until May 2012. CRS put lot of effort in the management of diverse groups of experts, cardiologists, oncologists to ensure that logistical processes run as smoothly as possible.

Assumptions:

  • Monoclonal antibody (mAB) for an oncological treatment
  • Known critical cardiac safety profile according to the SMPC
  • Clinical conduct in 6 months with more than 100 healthy subjects
  • IMP preparation & labelling immediately prior to dosing under GMP conditions
  • Integration of external specialists (cardiologists) for cardiac safety assesments and provison of a Data Safety Monitoring Board
  • Adaptive trial design to combine pilot & pivotal part in one CTA

Solution:

  • Involvement of two clinical sites of CRS to enable simultaneous dosing in small subgroups of max. 4 subjects per day and site
  • Strict standardisation of the working procedures and copperation with two external cardiologists
  •  Stepwise IV dosing procedure to ensure tolerability and safety in healthy volunteers
  • Intensive safety monitoring over several hours

Results:

  • Clinical duration in strict adherence to the timeline commitment, the subjects were enrolled in 6 months.
  • Highest quality in conduct and documentation according to CRS standards (Query rate…)
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