IVR Clinical Concepts provides custom ePRO, IVR/IWR and Randomization & Trial Supply Management (RTSM) services for Hematology Phase I-IV Clinical Trials.
Our experience includes providing essential study services (IVR/IWR, Clinical Trial Material Management, and EDC integration) in multiple countries for Hematology clinical trials.
Client | Indication | Phase | Description | Countries | Sites | Subjects |
Biopharma | Von Willebrand’s Disease |
IV |
IVRS registration, randomization and ePRO use of PRN DDAVP in patients with various types of bleeding episodes – dysmennorhea, dental, sports and every day bleeding. DDAVP was administered intranasally in anticipation of precipitating events. |
USA |
89 |
364 |
Biopharma | Clotting, Thrombosis |
IIa |
IWRS randomize and dispense CTM (RTSM), accommodated 2 stage study, and complex randomization schema, EDC integration |
USA |
1 |
40+40 |
Biotech | Hemophilia B |
I/II |
IRT Subject registration, observational, 1 arm open-label, Factor IX 5+ year study. Novel web-based ePRO PRN daily diary collecting bleed episodes, treatment effects, 7 languages EU, chosen based on 9 site locations, EDC integration |
Netherlands, Germany, Sweden, Denmark, Spanish, English, Italy |
9 |
10 |