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

Here are recent examples of our clinical trial experience:

Client

Indication

Phase

Description

Countries

Large Biotech Olanzapine Induced Wt Gain

I

IWRS-IVRS Randomization, IWRS CTM Management-Dispensation, Subject IVRS Validated instruments and Medication Dosing diaries, in phase I, 2 site, 90 subject study.

USA

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

Large Biotech Major Depressive Disorder (MDD)

II

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

USA

Large Biotech Chronic Stable Schizophrenia (CSS)

I

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

USA

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

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

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

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

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

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

Large Pharma Angina

II

IVR diaries to record frequency and severity of angina episodes

USA

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

Academic HIV Positive Young Men

Obser-vational

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

Academic College Students

Obser-vational

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

Large BioPharma Acne Vulgaris

III

RTSM for Two Multi-center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Studies of the Safety and Efficacy of IP Lotion in the Treatment of Acne Vulgaris for 12-20 Weeks. One Site-User URL with automatic direct to the appropriate study database based on log-in information, to separate and manage RTSM for two distinct pivotal Phase III studies.

USA

Specialty Pharma Restless Leg Syndrome (RLS)

II

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

USA

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

Biopharma Seasonal Allergic Rhinitis (SAR)

III

Twice a day windows of Voice TNSS collected from subjects, resulting in FDA approval of generic IP.

RSA, USA

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

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

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

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

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

Biopharma Clotting, Thrombosis

IIa

IWRS randomize and dispense CTM (RTSM), accommodated 2 stage study, and complex randomization schema, EDC integration

USA

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

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

Mid-size BioPharma Research GI Cancer/Thrombosis

IV

Site users randomized subjects using centralized web-based application, 62 sites, 740 subjects.

India

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
NL, IT, DE, DK, BE, SE, ES
Academic Methodology

IV

Pilot Paper-Voice verification studies evaluating several validated instruments, including Bristol Stool Scale, verifying no bias between modes of data collection from subjects, to ensure feasibility of voice mode for QofL questionnaires.

USA

Academic Low Testosterone-Hypogonadal Men

IV

Site IWRS registration and randomization, with assignment to several different validated instrument IVRS sub-studies, 10 sites, 800 men.

USA

Large Biopharma Seasonal Allergic Rhinitis (SAR)

III

BYOD, voice telephone, collecting scheduled TNSS validated instrument daily diary. Study IP was accepted by FDA

Republic of South Africa (RSA)

Large Biopharma Seasonal Allergic Rhinitis (SAR)

III

BYOD, voice telephone collecting scheduled TNSS validated instrument daily diary. Study IP was accepted by FDA.

USA