solution management clinical trial

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Clinical Trial Management Solution Digitize safety & vigilance management and improve patient safety & Achieve Compliance.

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Page 1: Solution Management Clinical Trial

Clinical Trial ManagementSolutionDigitize safety & vigilance management and improve patient safety & Achieve Compliance.

Page 2: Solution Management Clinical Trial

CLOUDBYZCloudbyz offers innovative end-to-end SaaS solutions for the life science industry with customer-centricity at its core.

Our product portfolio is built on Salesforce platform and delivers flexible and easy deployment features suitable for varied requirements across the lifescience and enterprise IT domain.

Global Offices Team Domain expertiseHQ in Chicago.

Offices in Los Angeles, Toronto, Bangalore

90+ global employees with expertise in Clinical Research & Digital

Technologies

100% workforce certified in Good Clinical Practice (GCP)

IncorporationFounded in 2014, registered in

United States of America

90+ 75+ 25 250+ 300+ 50

Employees HLS and R&D Customers

HLS and R&D Solutions

HLS and R&DProjects

HLS, R&D & Salesforce

Certifications

HLS and R&D Domain Experts

Page 3: Solution Management Clinical Trial

Our Marquee Clients Helping Life Sciences organizations to find cure faster and save lives with

innovative digital solutions and services

Page 4: Solution Management Clinical Trial

Integrated Clinical Trial Management Solution

Page 5: Solution Management Clinical Trial

Cloudbyz Decentralized Clinical Trial Platform

PLANNING

STARTUP

CONDUCT

CLOSEOUT

STUD

Y M

ANAG

EMEN

T

ACC

OUN

T M

ANAG

EMEN

T

PRO

JEC

T M

ANAG

EMEN

T

ACTI

VITY

MAN

AGEM

ENT

DO

CUM

ENT

MAN

AGEM

ENT

(eTM

F)

SITE IDENTIFICATION

BUDGET MANAGEMENT

SITECLOSEOUT

SITE CLOSEOUT VISIT

ESSENTIAL / REGULATORY GREEN LIGHT

RESOURCE PLANNING

SITE TRAINING

SAFETY / AE

FINAL SDV/TMF

IP RECONCILIATION

EDC (CRF / SDV)

REGULATORY HASUBMISSION

SUBJECT MANAGEMENT

SITE CONTRACT CLOSEOUT

STUDY CLOSEOUT

CLOUDBYZ CLINICAL RESEARCH CAPABILITY MAP

IRB SUBMISSION& APPROVAL

SITE INITIATIONC

ON

TAC

T M

ANAG

EMEN

TSITE FEASIBILITY SITE

QUALIFICATION

PATIENT RECRUITMENT

CONTRACT MANAGEMENT

SITEMONITORING

PROTOCOLDEVIATION

SITE PAYMENTS MANAGEMENTIN

VEST

IGAT

ION

AL P

ROD

UCT

MAN

AGEM

ENT

SITEACTIVATION

SITE ISSUE MANAGEMENT

SITE ESSENTIAL DOCS

CROENGAGEMENT

SITE INITIATION VISIT

STUDYBUDGET

CLOSEOUT

eCONSENT

Page 6: Solution Management Clinical Trial

Digital Platform for Clinical Trial Management

Patient Recruitment | Recruitment Campaigns|

Pre-Screen | eConsent | Cohort Analysis

Investigator Recruitment | Feasibility Reports

Study Management | Start-up | Site Management | eTMF | Monitoring | Budgets & Payments | Visits | eCRF| ePRO | Adverse Events | Protocol Deviation | IP Management |

Project Management

ClinicalWave : Investigator & Patient Engagement CTMS

Investigator Portal Sponsor PortalPatient Facing Website/App Investigator Facing Website

Patient Recruitment & Start-up Team Clinical Trial Operations, Finance, Regulatory Teams

Page 7: Solution Management Clinical Trial

1. Clinical Trial Operations Management

1. Clinical Trial Budget Management

2. Clinical Trial Management (CTMS)

3. Study Start-up

4. eTMF

5. Investigator Portal / Site Portal

6. Sponsor / CRO Portal

7. EDC (eCRF, eConsent, ePRO, eCOA)

8. Risk Based Monitoring (RBM)

2. Clinical-Wave – Patient Recruitment

1. Study Start-Up Community

2. Investigator Recruitment Portal

3. Patient Recruitment

4. Patient Recruitment Portal

3. Safety & Pharmacovigilance

4. Medical Affairs

1. Investigator Initiated Trials & CPU

2. Grants Management

3. Market Access Programs Management

5. R&D Portfolio Management

6. Patient Services

CLOUDBYZ Life Sciences R&D Solution

Accelerators on Salesforce.com

Page 8: Solution Management Clinical Trial

Cloudbyz Clinical Research Solutions on Salesforce.com

Planning Study Start-up Conduct Closeout

InvestigatorRecruitment

StudyStart-Up

PatientRecruitment

Budget &Payments

CTMS MonitoringeTMF, AE/PD

IP Accountability EDC (eCRF /ePRO /eCOA/eConsent)

Clinical QMS

Investigator PortalSponsor Portal

CRO PortalSafety &

Pharmacovigilance

Template Based

Connected Processes

Real-time Visibility

Industry Best Practices

Configurable and Plug &

Play Capabilities

Page 9: Solution Management Clinical Trial

Cloudbyz ClinicalTrial Management

Solution

Page 10: Solution Management Clinical Trial

Digital Platform for Clinical Trial Management

Study Management Study Monitoring Study & Site Budget Management

Investigator Portal Integrated eTMF Sponsor Portal

Page 11: Solution Management Clinical Trial

Patient Recruitment Solution Overview

Patient Public Facing Website Patient Recruitment Portal Investigation Recruitment Portal

Patient & Investigator Recruitment Application

Page 12: Solution Management Clinical Trial

Dinesh KashyapThank you