Our experience in Gastroenterology includes providing modality verification pilot studies for validated GI-specific diaries and questionnaires.

IVR Clinical Concepts provides ePRO and IVR/IWR, Randomization & Trial Supply Management (RTSM) and other specialized study services for Gastroenterology clinical trials.

Client Indication Phase Description Countries Sites Subjects
Large Biotech Opiod Induced Constipation (OIC)

II

30 center, 150 subjects phase II, IWRS-IVRS RTSM, IVRS ePRO daily Diary recording rescue medication dosages, and Validated Bristol Stool Scale (BSS) questionnaire, using color, laminated picture card for a visual subjects aid. System engagement was ensured by alerting subjects to enter data daily, whether a trigger event occurred, or not.

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USA

30

150

Large Biotech Methodology-Opiod Induced Constipation (OIC)

II

Pilot Study with 30 sites verifying daily diary data collection modality options, Voice compared to Paper. Subjects reported voice phone use was easy, according to e-query after 10 days of run-in diary.

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USA

30

150

Global Biopharma Irritable Bowel Syndrome (IBS)

II

IBS-M/U Phase 2 study, in which a standalone ePRO questionnaire in both web-based (including BYOD Android and iOS) devices and voice modes was administered for 12-16 week Daily Diary, collecting data from ~150 patients in the US for primary and secondary efficacy analysis. eDocumentation of PASSING grade using eTraining sandbox for subjects’ validated study daily diary. Sites used an integrated web interface to register patients to the survey systems and to see reporting functions. Run-In diary was used to determine inclusion to randomization.

USA

12

300

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

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