IVR Clinical Concepts has deployed patient/subject registration, randomization, trial supply management (RTSM) and ePRO/eCOA clinical services for numerous global projects and studies.
We work with top 10 Pharma companies, large academic institutions, innovative specialty biotechnology companies, large and small CROs, medical device companies, commercial service companies, healthcare groups, Oncology consortia, and EDC technology providers around the globe. Our application is highly scalable and able to accommodate small individual site IIT studies to large multi-national trials with unlimited numbers of sites, subjects, and modalities, with varying complexities.
We are experienced in optimizing the use of Voice (IVR), Web (IWR) and Mobile (IMR) modalities, taking into account the project’s global locations, subject profile demography, and specific goals of the study protocol.
We routinely implement our certified “forward – backward” language translations and native spoken dialects into our systems to enhance ease of use and patient-subject understanding.
Our clients appreciate our high level of clinical and therapeutic experience and excellent communication.
We engage in the exchange of best-practices with our clients, with the goal of an on-time, on-budget and successful clinical study.
Successful Clinical Trials = Successful Partnerships
| 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 |
| 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 |
| 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 |
| Client | Indication | Phase | Description | Countries | Sites | Subjects |
| Academic | College Students |
Observational |
NIH grant with voluntary participation by college students, with novel ePRO to capture behavior and attitudes during course of semester. Monetary incentive program which tracked completed diaries in real-time and reported up-to-date accounts to subjects and study personnel through our on-demand web reporting. |
USA |
1 |
400 |
| Academic | Methodology |
IV |
Two Pilot correlative Paper-Voice verification studies evaluating several validated QofL instruments, including FACIT, UCLA, PANAS, PHQ9, and SF-36, with statistical verification showing no bias when replacing paper modality with interactive voice-phone ePRO system collecting data from older hypogonadal subjects. |
USA |
4 |
50 |
| Academic | Low Testosterone-Hypogonadal Men |
IV |
By using an IWRS system, sites registered and randomized subjects to trial product or placebo and then assigned subjects opting in to one or more sub-studies. Several of the sub-studies required subjects to complete specific Quality of Life questionnaires using IVRS phone call-in system. Subjects received reminders to engage questionnaires at various timed intervals specific to their sub-studies. Subjects’ instances of ePRO completion was electronically monitored and reported to site personnel, to help ensure continued high levels of compliance. |
USA |
10 |
800 |
| 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. |
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. |
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 |
| Client | Indication | Phase | Description | Countries | Sites | Subjects |
| Biopharma | Seasonal Allergic Rhinitis (SAR) |
III |
Twice a day windows of Voice TNSS collected from subjects, resulting in FDA approval of generic IP. |
South Africa, USA |
42 |
816 |
| Large Biopharma | Seasonal Allergic Rhinitis (SAR) |
III |
BYOD, voice telephone, collecting scheduled TNSS validated instrument daily diary. Study IP was accepted by FDA. |
South Africa |
38 |
792 |
| Large Biopharma | Seasonal Allergic Rhinitis (SAR) |
III |
BYOD, voice telephone collecting scheduled TNSS validated instrument daily diary. Study IP was accepted by FDA. |
USA |
32 |
680 |
| Client | Indication | Phase | Description | Countries | Sites | Subjects |
| Late Stage Biotech | Necrotizing Soft Tissue Infections (NSTI) |
II |
Randomization and Trial Supply Management (RTSM), multi-center, extremely time-sensitive centralized two arm Standard of Care (SOC) + Investigative Product (IP) randomization, unblinded pharmacist notification for 1:1 randomized IP dispensation. |
USA |
65 |
290 |
| Academic | HIV Positive Young Men |
Observational |
Pilot study verifying daily diary data collection modality options, with voice compared with web-based (including BYOD) to determine most convenient method for 18-24 males to submit novel QOL, drug use and sexual and social behavior reporting, over 60 days. |
USA |
3 |
67 |