For Investigator sponsored studies e.g. Investigator Initiated Studies (IIS’s) or Investigator Sponsored Trials (IST’s), how do you supply the investigators with product:

Investigational Medicinal Product (IMP):

a) Bulk tablets, syringes, vials etc. for the investigator/sponsor to pack and apply their own clinical label
b) Generic labeled supplies e.g. English label (Description, lot #, Exp date etc.) for investigator/sponsor to apply their own clinical label
c) Clinically labeled supplies specific for the investigators study, meeting local regulatory requirements
d) Other (provide details)

Commercially available product:

a) Commercial product specific for a country e.g. German product for German investigator, for the investigator/sponsor to apply their own clinical label
b) Commercial product specific for a region e.g. German product for all the European Union, for the investigator/sponsor to apply their own clinical label
c) Generic labeled supplies e.g. English label (Description, lot #, Exp date etc.) for investigator/sponsor to apply their own clinical label
d) Clinically labeled supplies specific for the investigators study, meeting local regulatory requirements
e) Other (provide details)