PHT LogPad With Simple Send
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The Voice of the Patient — Delivered LogPad ® System with SimpleSend™ Transmissions Trustworthy Patient Data Not too long ago, it would have seemed impossible for sponsors, sites and regulatory authorities to trust PRO data captured outside the clinic. • How could researchers know when a patient filled out a diary? • How could data managers reconcile illogical responses? (For example, a patient who reports no pain, but then rates evening pain intensity as 7 out of 10.) • How could sites know when a patient was non-compliant, perhaps for weeks at a time, or entering worsening symptoms? PHT’s LogPad System has forever changed the way ePRO data are captured and managed in clinical research. Protocol-specific eDiary applications, designed with support from PHT’s PROVision™ scientific team, use intuitive features and quality controls to transform complicated diaries into simple ones. Features Benefits • Restricted time response windows • Accurate timestamps Timely and verified data entry with no unplanned recall bias or prospective responses. • Reminder alarms • Regular communication with sites • Missed Diary Minder High compliance and fewer subject drop-outs to reduce missing data. • Branching logic • Edit checks • Structured response options Logical, legible and complete data and significantly eased respondent burden. • SafetyPRO™ alerts • Missed Diary Minder Proactive safety and compliance management enabled by automatic email and phone alerts based on custom criteria and thresholds • TrueCompute™ calculations Real-time symptom and eligibility scores are performed on field devices without having to connect to the server. • 100% application integrity LogPads prevented from reverting to PDAs after soft/hard resets or battery loss; timestamps are always accurate. • Private access codes Confidentiality elicits honest subject answers in trials for sensitive indications. eSense™ Measurement Device Integration Research shows that subjects report false measurement data by transcribing it incorrectly or by outright inventing it. Consider the asthma sufferer who forgets his Peak Expiratory Flow (PEF) meter at work and estimates an evening FEV 1 score, or the diabetic patient who misreports her high blood sugar level. eSense solves these problems by integrating objective physiological measurements directly with subjec- tive self-assessments on the LogPad using Bluetooth, infrared and exclusive low-power RF. By ensuring measurement devices are used appropriately and on time, according to the protocol, eSense enables scientific researchers to ask new questions and provides sponsors with a more complete patient picture. The LogPad’s flexible architecture is deployed on a range of convenient touchscreen devices from proven hardware manufacturers including Hewlett-Packard and Palm. PHT’s experienced PROVision science team and expert project managers help sponsors determine the ideal device for their specific study and patient population requirements. In one client study, 174 subjects were given the choice of either using eSense or transcribing data manually into the LogPad after each blow into a PEF meter. 86% of 12,195 expected blows were recorded by eSense, while only 13% were transcribed manually and less than 1% were missing. Imagine the improvements in data reliability as compared to paper or other separate eSource methods!
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LogPad Mobile device designed to collect patient reported outcomes at home, for efficient clinical trial data management.
Transcript of PHT LogPad With Simple Send
The Voice of the Patient — Delivered
LogPad® System with SimpleSend™ Transmissions
Trustworthy Patient DataNot too long ago, it would have seemed impossible for sponsors, sites and regulatory authorities to trust PRO data captured outside the clinic.
•Howcouldresearchersknowwhenapatientfilledoutadiary? •Howcoulddatamanagersreconcileillogicalresponses?(Forexample,apatientwhoreports no pain, but then rates evening pain intensity as 7 out of 10.) •Howcouldsitesknowwhenapatientwasnon-compliant,perhapsforweeksatatime,orenteringworseningsymptoms?
PHT’sLogPadSystemhasforeverchangedthewayePROdataarecapturedandmanagedinclinicalresearch.Protocol-specificeDiaryapplications,designedwithsupportfromPHT’sPROVision™scientificteam, use intuitive features and quality controls to transform complicated diaries into simple ones.
Features Benefits
• Restricted time response windows• Accurate timestamps
Timelyandverifieddataentrywithnounplannedrecallbias or prospective responses.
• Reminder alarms• Regular communication with sites• Missed Diary Minder
Highcomplianceandfewersubjectdrop-outstoreducemissing data.
• Branching logic• Edit checks• Structured response options
Logical,legibleandcompletedataandsignificantlyeased respondent burden.
• SafetyPRO™ alerts• Missed Diary Minder
Proactive safety and compliance management enabled by automatic email and phone alerts based on custom criteria and thresholds
• TrueCompute™ calculations Real-timesymptomandeligibilityscoresareperformedonfielddeviceswithouthavingtoconnecttotheserver.
• 100% application integrity LogPadspreventedfromrevertingtoPDAsaftersoft/hardresets or battery loss; timestamps are always accurate.
• Private access codes Confidentialityelicitshonestsubjectanswersintrialsforsensitive indications.
eSense™ Measurement Device IntegrationResearchshowsthatsubjectsreportfalsemeasurementdatabytranscribingitincorrectlyorbyoutrightinventingit.ConsidertheasthmasuffererwhoforgetshisPeakExpiratoryFlow(PEF)meteratworkandestimatesaneveningFEV
1 score, or the diabetic patient who misreports her high blood sugar level.
eSensesolvestheseproblemsbyintegratingobjectivephysiologicalmeasurementsdirectlywithsubjec-tiveself-assessmentsontheLogPadusingBluetooth,infraredandexclusivelow-powerRF.Byensuringmeasurementdevicesareusedappropriatelyandontime,accordingtotheprotocol,eSenseenablesscientificresearcherstoasknewquestionsandprovidessponsorswithamorecompletepatientpicture.
The LogPad’s flexible architecture is deployed on a range of convenient touchscreen devices
from proven hardware manufacturers including Hewlett-Packard and Palm.
PHT’s experienced PROVision science team and expert project managers help sponsors determine the ideal device for their specific study and patient population requirements.
Inoneclientstudy,174subjectsweregiventhechoiceofeitherusingeSenseortranscribingdatamanuallyintotheLogPadaftereachblowintoaPEFmeter.86% of 12,195 expected blows were recordedbyeSense,whileonly13%weretranscribedmanuallyandlessthan1%weremissing.ImaginetheimprovementsindatareliabilityascomparedtopaperorotherseparateeSourcemethods!
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PHTCorporation
LogPad System with SimpleSend Transmissions
SimpleSend — for Reliable and Consistent Global TransmissionsCapturinghigh-qualityePROdataispartofthesolution,butitisonlyvaluableifsubjectsareabletotransmit—simplyandconveniently—fromanywhereintheworld.PHT’srobustfamilyofuser-friendlySimpleSendoptionsenablewiredandwirelessdatatransmissionsfromanyLogPaddevice.DataareencryptedandtypicallysentinamatterofsecondstoPHT’scentralserversoverasubject’shomephoneline.Increasingly,however,certainglobalgeographies(suchasAsia)andpatientpopulations(suchasstudents)lackareliablelandlineinfrastructureandrelyexclusivelyoncellularnetworks.Somesitesandtech-savvysubject,meanwhile,prefertoutilizehigh-speedInternetconnectionstosenddata.PHTprovidessponsorswiththefreedomofchoicebysupportingwired,wirelessandInternetauto-sendtelecommunicationsoptions.
Palm Devices Hewlett-Packard Devices
Wired SimpleSend TeleCradleTheTeleCradleistherecognizedindustry standard for sending datareliablyoveralandline.TheTeleCradlechargestheLogPad,sends data automatically, and does notinterferewiththesubject’shometelephone when set up.
SimpleSend Landline ModemHP’sdevicesareeasilyequippedwithcompactcardsthatfitintothetopoftheLogPadandenabledatatransmission.Subjectssimplyattachone end of a home phone line into the top of the card to transmit data.
Wireless SimpleSend Wireless PackThisPHTexclusivesledistheonlymobile device that enables cellular data transmission from a Palm. It attachestotheeDiarytoallowdataentry and sending from a single convenientdevice.TheWirelessPakalsochargestheLogPad.
SimpleSend Mobile CardTheMobileCardissimilartotheLandlineModeminthatitisinsertedintothetopoftheHPdevices.Itsbuilt-inantenna,however,enablesstrong cellular telecommunications overleadingglobalGPRSnetworks.
Internet SimpleSend Internet — PalmUsersconnecttheLogPadtotheirahigh-speedcableandtransmitdataseamlessly over the Internet.
SimpleSend Internet — HPThiscompactcardconnectstheLogPaddirectlytoahigh-speedcablefor Internet transmissions.
The Telecomm TeamPHTemploysadedicatedteamofexperiencedtelecommunicationsexpertswhosesolefocusistoimprovetheconvenienceandcon-sistencyofdatatransmissionsfromeverycountrywesupport.PHTcloselymonitorstransmissionsuccessratesofongoingsutdiesandmakesadjustmentsasnecessary.BypartnerningwithleadingproviderAT&T Worldwide, PHT’sTelecommTeamisabletodeliverthehighest level of service worldwide.
Site Telecomm Assessments PHThasdeployeditseDiarysolutionstomorecountriesthananyotherePROprovider,accumulatingunsurpassedexperiencetorecommendtheidealLogPaddevicetypeandSimpleSendcommunicationoptiondependingonparticularstudyandgeographicalrequirements.Foradditionalpeaceofmind,PHT’sthoroughSiteTelecommAssessmentserviceconsistsofacontinuousbatteryofdatatransmissiontestsdesignedtoreduceriskandprovideanextralayerofconfidenceinnewcountriesorareaswheretherehavebeen recent changes in the underlying telecommuncations infrastructure.
Don’t Take Our Word For It...PHT’sLogPadSystemwithSimpleSendtelecommunicationsisthepremiersolutionforcapturingandmanaginghigh-qualityePROdatainclinicaltrialsaroundtheworld.Byreducingrespondentburden,removingnumerousopportunitiesforerrorandfraud,andenablingconvenientandconsistentdatatransmissions,sponsorsandsitesbenefitfromreliabledatathatthey—andregulatoryauthorities—cantrust.Toseeforyourself,buildanduseaninteractiveLogPadattheaward-winningphtcorp.com.
