Case Studies

Case study: no ordinary scheme


Case study: no ordinary scheme

I've reared a monument not built by human hands.

The public path to it cannot be overgrown.

With insubmissive head far loftier it stands

               Than Alexander's columned stone.

by A. S. Pushkin


Our team has more than 20 years’ experience in clinical trials. You would think that we’ve seen everything. We thought exactly like that, but then The Scheme (it deserves both capitals, trust us) crossed our path. 


What would you generally expect from a drug dispensing scheme? Randomize the subject, keep the blind, dispense the drug according to the schedule, perform accountability. Easy-peasy.


The Scheme has the following ordinary characteristics:

  • Randomization into one of the treatment arms (placebo / IP)
  • Drug administration schedule with applicable visit windows
  • Subject Unblind can be performed at any moment


And a whole bunch of no ordinary conditions that you will hardly ever meet in a drug dispensing scheme. Each condition is a challenge on its own. We got a c-c-c-combo.


Before IP assignment and administration the following has to be taken into account:


  • IP dose escalation steps are based on clinical event for the subject
  • Clinical event is defined based on main disease symptoms and laboratory findings
  • IP dose escalation scheme requires subject unblinding at some point, but not always!
  • Days passed since the most recent IP assignment
  • The maximum dose must not be exceeded - hence the cases with subject unblinding
  • IP administration after subject Unblind is also possible


The icing on the cake:

  • IP administration on Unscheduled visits
    • Treatment option choice for the next IP administration (see condition about days above)
    • Is the administration schedule shifted afterwards?
    • Unpredictable number of Unscheduled visits
    • Challenge for drug supply procedure


  • No IP administration on the next planned visit is expected after Unscheduled visit administration
    • Applicable only for some cases with IP administration on Unscheduled visits
    • Still, have to count the days since last drug assignment
    • Still, have to check the amount of specific clinical events
    • And check if the Subject is unblinded


MainEDC™ System with integrated IWRS module flawlessly met these challenges. 


Starting from dynamic eCRF logic with branching triggers and up to the support of complex treatment algorithms - step by step all testers survived the System configuration was performed.


Original estimates turned out to be more than sufficient for the configuration and our team was happy to deliver the task ahead of the deadline. MainEDC™ made The Scheme friendly and intuitively understandable. 





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