ClinOne

ClinOne is dramatically changing the landscape of clinical trial management to

accelerate clinical trial execution, reduce costs and provide patients with

access to life-changing clinical trials to advance medicines far more rapidly

than today.

ClinOneisutilized inmorethan2,500trialsworldwide

Utilizedin48countries

Availablein6languages

1,000’sofresearchinstitutions

ClinOneCoreSolutionClinOneprovidesmeasurable, invaluableresults

o Changingthelandscapeofclinical trials

o Increaseenrollmentby93%

o Reducingclinicaltrial timelinesby5.5to14months

o Increasepatientretentionby42%

o Reduceprotocoldeviationsby62%

o Reduceadministrativeandmonitoringcostby18%

o Reducetheneedtocontractwithmultiplevendors

o Increasecompetitiveadvancementofstudieswithinresearchsites

SiteEngagement

ClinOne simplifies continuous site engagement through the study

community including study updates, cohort updates, clarifications,

webinars, and weekly/monthly updates. The technology provides real-

time push notifications, e-mail messaging and read confirmations. The

system may also be utilized for forum-like discussions across your

studysitestoengage.

Increase Screening atPoint-Of-Care

ClinOne intersects a patients treatment path and allows research

teams to identify which study is best suited for each patient. The

technology provides real-time screening for the latest protocol

version. It's the second most utilized feature within the ClinOne Core

Solution,screeningpatientswithin60seconds.

Study Documents andVideos

ClinOne provides access to digital study binder and quick reference

guides that were previously provided through printed materials.

Documents are site version specific, allowing sites to only access

approveddocumentsandprotocol versions.ClinOne offers the unique

ability to stream confidential and training video content directly

through its web and mobile application. Recorded investigator

meetings,detailedprocedurevideos, trainingvideosandstudyupdates

aresecurelystreamedthroughthemobileapplication.

Schedule ofEvents Manager

A single study can require research sites to perform 400 to 800

investigational procedures per patient, or 140,000 procedures if

they have enrolled 3 patients per study across their portfolio of 30

to 60 studies. To eliminate missed procedures and unnecessary

protocol deviations, ClinOne has simplified how research sites

manage and organize their patient procedures across multiple

studies,armsandvisitsthroughourmobileworkflowtechnology.

Adverse EventsManager

Adverse events can occur unexpectedly requiring investigators to

rapidly respond and make treatment decisions using study-defined

guidelines that are buried within an extensive protocol document.

ClinOne programs the dose modifications and adverse events of

special interest guidelines from the protocol and places them in a

simple searchable format for investigators andstudy personnel.

AutomatingReferrals

ClinOne displaysyour clinical trial to other treatment centers near

your open and recruiting sites, allowing visibility of your clinical

trial to referring physicians.Automated communicationsmaintains

continuousengagement.

EmpoweringPatients

40% of patients report not understanding the nature of clinical

trials and fewer than 2%of patients receive information about the

trials they are considering. ClinTrialConnect is reshaping how

patients interact with information, providing a knowledge base

portal to learnaboutaspecific clinical trial, andallowing thepatient

tosharedetailswith familymembers.

DigitalConcierge

42% of patients fail to meet study visit requirements after

enrollment. Over 80% of studies fail to retain patients for the

completedurationof atrial.ClinOneprovidespatientswithadigital

concierge technology to manage their clinical trial experience,

assuring greater visit compliance and retention in studies.

ClinOne’s technology provides patients and their families a central

resource to manage their visits calendar, guidance on

travel/logistics with Google Maps integration, visit expectations,

alertsandremindersacross30 languages.

SecureMessaging

92% of research sites are challenged with effectively

communicating with their research patients resulting in missed

appointments, insufficientpreparedness for visitsand lackof study

engagement. ClinOne has integrated a secure messaging platform

between research sites and research patients to provide HIPAA

compliant, fully encrypted, continuous communication and

document sharing.Study sponsors mayalso provide IRB approved

study-level messaging, study updates, and safety updates with

readconfirmationswithpatientstomaintainstudyengagement.

Patient DocumentManagement

Study document and safety update management is a critical for a

patients and their families. ClinOne's Digital Concierge provides

patients with a HIPAA compliant study management portal to

manage informed consents, study documents and safety letters.

Researchsitesandsponsors canuploaddocuments intoapatient’s

document portal to build a complete online document library to

improve the patient’s experience. Read confirmations are sent

back to the research sites to improve compliance and

documentation..

ClinOne cloudencryption

ClinOne data resides in Microsoft Azure, the second largest cloud computing service in the world. All

sponsordataandstudycontentisfullyencryptedwhilestoredwithinMicrosoftAzureenvironment.

ClinOne DataTransmission

User and study data is encrypted while transmitted through the

internet from Azure to smartphones. In addition, ClinOne

utilizes SSL(SecureSockets Layer)which is the standard security

technology for establishing an encrypted link between web

servers and devices/browsers. This link ensures that all data

passed between the web server and browsers remain private

and integral.

ClinOneCompliance

ClinOne maintains a complete audit trail for additions,

modifications and archiving of any content and user actions

within ClinOne. FDA CRF Part 11 compliant. HIPAA

compliance.