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

Clinical Trial Case Study, ePRO, IVR, IWR, IRT Case Studies

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