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 |