disrupting clinical trials in the cloud

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Disrupting Clinical Trials in The Cloud

We streamlineyour clinical trials.

Utah InnovationAwards Finalist

2© 2016 Clinovo. All Rights Reserved.The contents of this document are confidential and proprietary to Clinovo

Clinical TrialsBefore EDC


Paper based solutions

EDC

Talend White Paper, 2011, TheReturn on Investment of OpenSource Data Integration.

30%

14%

47%

NUMBEROF QUERIES

OVERALLDURATION

OVERALLCOST “Use of EDC resulted in a 70-‐80

percent reduction in queries with

over half of all queries resolved on

their own.”

Eli Lilly

Regional Operations Manager

The Promise of EDC


• 50% of clinical trials still conducted on paper, causing: -‐ Quality and efficiency issues

-‐ Regulatory risks

EDC Adoption Rate

Traditional EDC systems are costly, long and complicated to implement.


IntroducingCloud-‐Based EDC


How can small and mid-‐sized biotech companies benefit from cloud-‐based eClinical systems?

Cloud-‐Based EDC

Speed of implementation?

Ability to scale up, or down, quickly?

Increased autonomy and user empowerment?

Lower cost of technology adoption?


Marketing Definition:

What is a ‘Cloud’?


Technical Definition:

What is a ‘Cloud’?


Resource poolingElasticity

Mandated by the US Government under the Federal Cloud Computing Strategy in Feb-‐2011. Defined by the NIST:

On-‐demand self serviceUbiquitous network accessMeasured services (SLA)

Cloud Computing


Self-‐service:Empowered Users

Measured Services:Pay-‐as-‐You-‐Go -‐> Lower adoption cost

On Demand:Speed Of Implementation

Elasticity:Scale up/down quickly

The Cloud in Clinical Trials


Self-‐ServiceBuild/Deploy Studies

Pay-‐As-‐You-‐GoFree to Get Started

DIY BuilderNo Learning Curve

Scalability1 to +10,000 Patients


Speed of implementation


“In one week, we were able to build case report forms and deploy the study database, and the following week we were already collecting data. Prior to using ClinCapture, I was new to EDC

and had no programming experience.”

Jon Lyons, PhD MBA – ManagerClinical Operations & Medical Science Liaison at Providence Medical Technology

ü Fast set-‐up: Create and deploy your study to the cloud in hours

ü Short learning curve: Intuitive GUI, drag-‐and-‐drop, training resources

ü Study go-‐live between 1-‐8 weeks depending on study size

Speed of Implementation


Increased Autonomy And User

Empowerment


ClinCapture Build Studio

Drag and Drop Simple to Complex Edit Checks.

Build CRFs in just a Few Days.

Self-‐ServiceFully Free CRF Designer.

Create Your CRFs Yourself.

No ProgrammingNo Previous Programming

Knowledge Required.


Ability to scale up, or down, quickly


ü Automatically supportan increase or decrease in study size

ü Mid-‐study changeperformed seamlessly by users

ü Automaticprovisioningof additional space andmemory

ü No change in the physical infrastructure

ü No delays and additional costs

Elasticity and Scalability


STANDARDFREE

Role-‐Based EDC

Data Exports

Data Clarification Form

Forms Studio

Rules Studio

21 CFR Part 11 Compliant

Private Cloud Hosting

ClinCaptureVirtual Update

eLearning Tutorials

Language Localization

Community Forum Support

PREMIUM

CRF Annotations

Dynamic Groups

Calendared Visits

Interactive Dashboards

Item Level SDV

Subject Casebook in PDF

CRF Masking

SAS Extracts

CDASH CRF Library

CRF Evaluation

Support Level 1

ULTRA

Randomization *

ePRO*

Medical Coding*

CDISC SDTM Data Sets*

CTMS Integration*

EMR Integration*

Web Services API

Global Hosting Preference

Support Level 2

* Additional one-‐time setup fees apply with use of these features.

Pay-‐as-‐you-‐go Model


Global Reach

14,000Clinical trial professionals adopting

ClinCapture EDC

56 Countries leveraging ClinCapture

Build Studio features

1,100ClinCapture Build Studio users

as of February 2016

disrupting clinical trials in the cloud

Healthcare