Study procedures conduct

«BioEq» investigators assess the health of trial subjects throughout the trial by asking subjects about adverse events;

  • medical examinations;
  • measuring vital signs such as heart rate and blood pressure;
  • routine safety tests of blood and urine;
  • continuous monitoring of variables such as the ECG and pulse oximetry;
  • and trial-specific tests

The investigator follows up:

  • all subjects after their last dose of IMP, for period depending on the IMP and the trial;
  • subjects with adverse events, including clinically relevant abnormal laboratory results, until they have resolved or it is clear that they are resolving; and
  • subjects who withdraw or are withdrawn from a trial, as if they had completed it, providing they agree.