Our team is experienced in providing ePRO, randomization and CTM services for Oncology registries and Phase I-IV Clinical Trials.
IVR Clinical Concepts provides Oncology clinical trial services including ePRO and IVR/IWR and Clinical Trial Material Management (CTM).
| Client | Indication | Phase | Description | Countries | Sites | Subjects |
| Biopharma | Ovarian Cancer | II | Site users use administrative account reviewed application to self-register to phase II study. Sites register/randomize subjects and generate User ID and initial Pass-code to provide to subjects to self-register to diary. Sites and subjects received email notifications when registered. Site Trial Supply Management included receipt of CTM, dispensation notifying pharmacist of treatment group in real-time. System provided virtually instant email notification confirmations and appropriate blinded or unblinded reporting to Site users and Pharmacists. | USA/EU | 25 | 80 |
| Top 10 Pharma | Chronic Myelogenous Leukemia (CML) | Registry | IWR/IMR ePRO, validated FACT instruments, subjects self-register, alert text/email to subjects when diary window was OPEN and warning text/email as diary neared its CLOSE. | USA | 30 | 170 |
| Top 10 Pharma | Metastatic Renal Cell Carcinoma (MRCC) | Registry | IWR/IMR ePRO, validated FACT instruments, subjects self-register, notification to subjects when diary available. | USA | 60 | 500 |
| Top 10 Pharma | Breast Cancer | Registry | Off-site subject self registration to 5 year study, with reminder notifications at predetermined 1 month, 3 month, 6 month and annual intervals. | Italy, Germany | 50-80 | 500 |
| Top 10 Pharma | Breast Cancer | Registry | Sites registered subjects to IWR/IMR subject scheduled validated questionnaires using IWRS. Subjects self-registered voluntarily to diary in real-time at first visit. iOS devices provisioned for study use as needed. 100 sites, 1500 subjects over a total of 5 years. | USA | 100 | 1500 |
| Large Biopharma | Breast Cancer | IIb | IVRS registration and ePRO to record the time of patient’s self injection of GMCSF to prevent reduction in white blood cell count; record body temperature at least 4 hours after each as a measure of infection | USA | 8 | 48 |
| Mid-size BioPharma Research | GI Cancer/Thrombosis | IV | Site users randomized subjects using centralized web-based application, 62 sites, 740 subjects. | India | 62 | 740 |
Contact us to discuss how our team can help you overcome study challenges.
Together, let’s make your next project a success.
