IVRCC IVR, IWR solutions for CNS and Neurology Clinical Trials and Studies

Our team develops custom solutions for Central Nervous System & Neurology clinical studies and Phase I-IV Clinical Trials. Our experience in CNS & Neurology clinical trials includes ePRO and IVR/IWR, Randomization & Trial Supply Management (RTSM), Clinical Trial Material Management (CTM), and other essential study services.

Client Indication Phase Description Countries Sites Subjects
Large Biotech Major Depressive Disorder (MDD)

II

Real-time calculations of pre-randomization diary questionnaire responses for inclusion to randomization, spanning 25 sites.

USA

25

130

Large Biotech Chronic Stable Schizophrenia (CSS)

I

Subject IVRS to record medication dosing confirmation, in phase I, 46 subject study.

USA

1

46

Consumer Products Company Mentholated Cigarette Biomarkers

N/A

Randomization, single-blind, parallel-group, multi-center controlled clinical study evaluating biomarkers of tobacco products exposures.

USA

10

480

Consumer Products Company eVapor Cigarette Biomarkers

N/A

10 site, 450 subjects in USA study to evaluate changes in biomarkers of cigarette smoke exposure when smokers switched to e-vapor products. Site web-based randomization.

USA

10

450

Biopharma Complex Regional Pain Syndrome (CRPS), a.k.a. Reflex Sympathetic Dystrophy Syndrome (RSDS)

III

Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of CTM Administered Orally, in 290 subjects over 46 sites. Subject self-registration mechanism to choose language. BYOD (smartphones, tablets, PC) web-based and Voice phone ePRO, collecting symptoms (0-10 pain scale) and medication dosing. Written English and Spanish, also including native UK, Australian and French Canadian voice talent.

UK, USA, Australia, Canada

46

190

Biopharma Knee Pain

III

Site users access web URL, workflow provided client’s choice of scheduled or manually pulled subject registration from EDC for subject IWR/IMR/IVR modality pain and medication dosing diary. Subject self-registration to diary, automatic diary language and voicing according to site location and subject primary language chosen. Reporting and data export on demand for study personnel.

USA, Australia

61

345

Specialty Pharma Restless Leg Syndrome (RLS)

II

Site web-based RTSM, dispensing titrated drug based on data collected at each of 7 visits.

USA

41

240

Specialty Pharma Parkinson’s Disease

II

CNS Study with 15 US sites and 60 subjects, managing screening and RTSM activities collected and implemented by Site IRT system. Two way data sharing with EDC system final database.

USA

15

60

 

 

 

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IVRCC ePRO solutions for Clinical Trials