ERT Products

Question 1

Trial Oversight (ODS)

Answer 1

Operational Data Store (ODS) - cloud-based trial oversight tool that 1) Ingests ERT data as well as third party data 2) Provides real-time business intelligence via standard/custom reports, 3) trial oversight detects anomalies at portfolio, study, and site level, 4) set tolerance levels to detect problems early, 5) communicate to study leaders within the workflow, 6) includes alerts.

Question 2

eCOA

Answer 2

Electronic Clinical Outcomes Assessment - supports handheld, tablet, web, IVR, and BYOD

Question 3

eCOA - Syndication

Answer 3

Also known as the Universal App 1) hardware agnostic, 2) simple install, 3) integration with other Apps, 4) consistent look/feel across devices, 5) single code base

Question 4

eCOA - VIAPhone

Answer 4

IVR solution - 1) time stamped, 2) real-time alerts, 3) connects to EXPERT platform

Question 5

eCOA - VIAWeb

Answer 5

Web-based solution - 1) any browser, 2) alerts, 3) connects to EXPERT platform, 4) single configuration with VIAPhone

Question 6

eCOA - NetPRO

Answer 6

Web-based solution - 1) patient enrollment, 2) daily diaries, 3) track adherence, 4) site coordinators/admins and patients, 5) connects to StudyWorks platform

Question 7

eCOA - AVERT

Answer 7

Suicide prevention - 1) uses Columbia Suicide Severity Rating Scale (C-SSRS), 2) alerts, 3) live calls, 4) patient or clinical reporting

Question 8

eCOA - Localization Tool

Answer 8

Translates study screens into localized languages, includes side-by-side comparison of English and other languages

Question 9

eCOA - Study Designer

Answer 9

Interactive software that 1) Supports customized workflows and team collaboration, 2) Mock up workflows on multiple devices, 3) User rights management, 4) Custom looping, branching, data calendars, text, templates, 5) therapeutic & assessment libraries, 6) code generation logic (website builder)

Question 10

Respiratory

Answer 10

1) Collects quality spirometry data, 2) 470 studies, 3) 80% of Respiratory Drug Approvals, 4) Calibrated devices & training, 5) Optimized workflows, 6) home monitoring, 7) connects to EXPERT platform, 8) real-time centralized data surveillance, 9) integration with Electronic Data Capture (EDC) systems, 10) proactive project management

Question 11

Cardiac Safety

Answer 11

1) Cardiac safety leading cause of delays and drug withdraws, 2) 6,200 studies, 3) 420+ drug approvals, 4) Phase 1/TQT ECG Phase 2-4 ECG Holter ECG Blood Pressure Monitoring, 5) centralized data collection, 6) 24/7 customer care team, 7) connects to EXPERT platform

Question 12

Imaging

Answer 12

1) quality of imaging modalities has improved (resolution, biomarkers), 2) regulatory agencies require imaging as part of submissions (additional data point), 3) selection of modality (which imaging), 4) unique compliance requirements due to images, 5) reading protocol to interpret images, 6) use software to reduce human bias, 7) RIS (Radiology Information Systems) and PAC (Picture Archiving & Communication Systems) have compliance issues - can’t be used for clinical trials