DATASHEET

ComplianceQuest
Clinical Trial
Management
Powered by Cloudbyz
Your ‘one-stop-shop’ for all clinical
operations and clinical quality needs
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Accelerate clinical trial processes with a

next-generation cloud-based Clinical
Solution, to reduce data processing time
and improve clinical study administration
across the entire trial lifecycle.

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Clinical Trial
Management
Study teams are increasingly being challenged to do more
with fewer resources. Delays caused by disconnected
systems, manual data re-entry, redundant workflows, and
information silos can seriously affect a trial’s progress. You
need a clinical management system that unifies and
streamlines workflows while still maintaining full visibility.

CQ Clinical, powered by Cloudbyz, delivers a next generation modern cloud,

integrated solution for end-to-end clinical trial operations with real-time data visibility.
CQ Clinical ensures streamlined, customer-centric support across all phases of
clinical trials including study start-up, patient recruitment, budgeting, study
management, pharmacovigilance, and study close out.

It also helps in cohesive communication amongst CROs, sponsors, and sites. The
ability to include all contributors, such as sponsors, CROs, vendors and study sites in
a secure and organized manner ensures the quality, completeness, compliance, and
a constant state of inspection readiness of your clinical trial and proof of a study’s
compliance with current Good Clinical Practice (GCP).

CQ Clinical, powered by Cloudbyz, offers integrated capabilities covering Clinical Trial

Operations, Study Start-Up, CTMS, eTMF, EDC, Safety & Pharmacovigilance, and
Decentralized (Virtual) Clinical Trials. It gives companies comprehensive control
over how clinical trials are operated, streamlined, recorded, reported, and tracked
in compliance with industry regulations and benchmarks. With the availability of
consolidated and updated data on a single platform, stakeholders of the clinical trial
can track all parties involved and benefit with data-backed, real-time decision
making.

Since CQ Clinical solution is 100% natively built on the Salesforce platform, the
solution also offers real-time analytics with easy to create reports and dashboards,
chatter collaborations, , granular level security and compliance, easily configurable
workflow and approval processes and support for multi-currency and multi-
language.

You need a next gen clinical trial management

system that unifies and streamlines workflows
while still maintaining full visibility.

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CQ Clinical
Features
Clinical Trial Operations

Study Management
Ability to manage clinical studies including study name, title, description, therapeutic
area, phase, inclusion, and exclusion criteria. Set up, track, visualize and manage any
number of clinical trials and studies based upon phase, type, therapeutic area,
indication, and sponsors.

Budget Management
Ability to manage clinical trial budgets both at the study level and site level. Easily set
up, track, and manage study budgets in real-time based on service lines and
activity-based costing. Have real-time visibility over actual costs, forecasts, budgeted
costs, and any variances. Included are budget templates of pre-estimated costs for
different assumptions and scenarios.

Payments
Track invoices, expenses, fixed costs, and roll-up payments automatically from
subject visit payments, sites, tasks, and pass-through payments. Provide submission
of real-time payment requests alongside monitoring payment status to reduce
unwanted downtime in clinical trials and improve financial transparency.

Drug & Device Accountability

Track all investigational products such as drugs and devices including shipment and
inventory tracking for improved operations.

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Study Start-Up

Site Feasibility and Assessments

Assess and evaluate the feasibility of sites potentially to be used in clinical trials.
Create feasibility templates and conduct online feasibility assessment surveys
alongside real-time access to survey responses for faster feasibility evaluation and
site activation.

Site Performance Metrics

Better track site details including equipment, staff, revenue, and performance metrics
related to previous trials.

Clinical Trial Management System (CTMS)

Project Management
Assigned teams can easily manage the activities, organizational resources, and
tasks to promote effective management of sites.

Site Management
Ability to manage clinical sites with site number assignment, address, contact
details, status, and investigator alignment which are participating in the study. Ability
to track and plan patient recruitment, forecasts, and actuals for sites.

Investigator Recruitment
Enables investigators to easily gain access to a feasibility study of any existing/
potential site with regards to clinical trials.

Patient Enrollment
Support management of inbound calls and fax, get quick status updates about
cases and care programs for ease of enrollment. Includes pre-screening question-
naires and information for patient volunteer’s eligibility configurable per study.

Subject Management
Get real-time visibility to subjects and subject visit activities and schedules. Better
collaboration and planning in monitoring visit coordination for accurate and efficient
monitoring reports.

Study Monitoring
Ability to track and manage site monitoring and trip reports. Site visits such as SQV,
SIV, IMV, and COV visits can be planned and monitoring reports can be created based
on templates.

Patient Portal
Patient portal enables digital patient recruitment with self-interest choice, patient's
own medical concerns and self-registration features for volunteers to facilitate
informed clinical testing.

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Investigator Portal
Easily collaborate with clinical sites, CRO and sponsors in real-time. Assists in
collection of study details, payments, subject enrollments, and submitting and
accessing eTMF documents.

eTMF

Drag and Drop Upload

Drag and drop functionality in the eTMF with easy movement of one or more files for
uploading in the desired electronic trial master file folder.

Manage and Generate Files

Transform manual paper handling tasks with automated collection, classification,
indexing, email archives, and medical imaging for ideal results. Facilitate easy
document generation in CTMS such as site green light process, protocol deviation,
adverse events and trip reports and save to eTMF by click of a button.

DIA Structure for Drugs and Devices

Automatic creation of eTMF DIA Reference Model structure helps upload the files
with the drag & drop feature to create electronic trial master file documentation
meeting TMF regulations.

EDC

eCOA & ePRO

Collect time-sensitive patient-reported outcome data digitally delivering real-time,
centralized visibility along with applicable notification and alerts.

CRF & eCRF

Easily capture, track, and manage case report forms (CRFs). eCRF offers
template-based, digitalized case report forms to collect data from multi-lingual
patients.

eConsent
eConsent enables real-time management of informed patient consent and
e-signatures. It includes template-based and interactive multimedia approaches to
expand the scope of eligibility testing.

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Safety & Pharmacovigilance

Protocol Deviation
Track and monitor protocol deviations in real-time to final corrective actions alerting
CRAs and site staff.

Case Management
Ensure scalability and end-to-end global case processing and safety process, E2B
intake, submission and periodic reporting.

Adverse Events
Track Adverse Events (AE) and submit regulatory reports based on
pharmacovigilance rules for seriousness and causality. Provides a centralized view
of all AER reports.

Event Analysis
Generate and review narrative case description. Supports additional data entry for
generating the MedWatch 3500A and BfArM pharmacovigilance reports.

Product Management
Improve pharmacovigilance (PV) by recording and managing details regarding
products and dosage regimens while building associations for pharmacovigilance
data accuracy.

Salesforce Service Cloud Connectivity

Streamline intake workflow with connectivity of Salesforce Service Cloud to safety
and pharmacovigilance solution.

Secure Patient Information

Ensures secure centralized secure storage of report data, patient information and lab
test results.

Decentralized (Virtual) Clinical Trials (DCT)

Facilitates end-to-end study, site and project management of decentralized clinical

trials delivering complete off-site and hybrid-based streamlined processes including
virtual patient recruitment, virtual visits for investigators/CRO and patients and
telemedicine for follow-ups.

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“$1M in lost clinical trial
productivity per day”
**PhRMA (2015)

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 Maintain compliance with clinical quality to help audit and verify clinical processes,
review, and approve clinical SOPs, train all clinical staff, escalate clinical issues for
CLINICAL QUALITY investigation, and gain more insight into risk detection and corresponding
prioritization, allowing you to design appropriate action plans and the closure of
CAPAs in sync with the stated risk management goals.

Use real-time graphics for snapshots and trends and to identify patterns as part of
REPORTING AND predictive analysis. Monitor open tasks and track outcomes via dashboards. Use
DASHBOARDS built-in best practice reports or create your own.

Facilitate public or private communications with researchers, patients, CROs, Sites for
COLLABORATION patient recruitment and retention in clinical trial.

MOBILE ACCESS Review, track and manage studies anywhere, at any time, on your own device.

Like and follow relevant records in the system. Choose to be notified via email,
SOCIAL LIKE & FOLLOW dashboard, and mobile to stay abreast of developments.

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 ComplianceQuest ComplianceFirst Cloud Platform for Life Sciences
AI Powered Solutions for Clinical, Quality, Health & Safety
EQMS
EHS
CLINICAL

Clinical Customer Quality Supply Chain Risk Workforce Safety Environment

CLINICAL MARKET SUPPLIER RISK AND WORKFORCE HEALTH AND

QMS ENVIRONMENT
TRIALS SURVEILLANCE & CONTRACTORS COMPLIANCE DIGITALIZATION SAFETY

Decentralized Complaint Audit Audit Audit Document Injuries, Vehicle, Spills and Releases
Clinical Trial Management Security, Property
Operations CAPA On/Off-Boarding Risk Register Management Sustainability
Regulatory Claims
Study Start-Up Assessment Change Control Accreditations Process Inspection SOP Management Permits
Enforcement
CTMS Regulatory Deviation Deviations JSA Safety Regulatory Library
Reporting Training Observations
eTMF Equipment SCAR Permit to Work Notice of Violation
E-Submission Change Near Miss
EDC Gateway Investigation Portal Investigation Audit
Learning Portal Regulatory Forms
Safety & Field Nonconformance Inspections
Pharmacovigilance Service Connector LearnAbout GMP Inspections
OOS/OOT PPAP
JSA
Product Inspection Document
Exchange Permit to Work

Supplier Ratings Management of

Change
Score Cards
Investigation
Permit to Work
Toolbox Talk

PLATFORM POWERED BY

About ComplianceQuest
ComplianceQuest is an Enterprise Compliance-First Management platform for Life Sciences with AI powered solutions
for Clinical, Quality, Safety and Environment natively built and run on Salesforce technologies.

We help our customers of all sizes deliver quality studies, products, and services in the safest, most sustainable way by
mitigating risk, problems, and inefficiencies while protecting customers, employees, suppliers, contractors, and patients.

For more information, or to request a demo with a ComplianceQuest expert, contact ComplianceQuest today

• Visit www.compliancequest.com
• Email us at marketing@compliancequest.com
• Call us at 408-458-8343

Fastest Growing 100% Native Salesforce Based Clinical, EQMS and

EHS Solutions – Mobile, Secure, Reliable, Scalable, Configurable

©2021 ComplianceQuest. All rights reserved. Confidential and Proprietary. Publishing of this content is not allowed without express permission from ComplianceQuest.
The information contained in this document is intended for general information purposes only and is subject to change without notice. Any third-party brand
names and/or trademarks referenced are trademarks of their respective owners.

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