IVR Clinical Concepts has deployed patient/subject registration, randomization, trial supply management (RTSM) and ePRO/eCOA clinical services for numerous global projects and studies.

Learn how IVRCC is different

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.

View Case Study

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.

View Case Study

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.

View Case Study

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.

View Case Study

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.

View Case Study

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.

View Case Study

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.

View Case Study

USA

3

67