![Page 1: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/1.jpg)
Pinnacle21EnterpriseFacilita'ngeSubmissionPrepara'onPhUSEAnnualConferenceOctober11,2016
![Page 2: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/2.jpg)
“SponsorswhosestudiesstartaDerDecember17,2016,mustsubmitdatainthedataformatssupportedbyFDAandlistedintheFDADataStandardsCatalog.ThisappliestoNDAs,BLAs,ANDAs,andsubsequentsubmissionstothesetypesofapplica'ons.”
-FDAU.S.FoodandDrugAdministra'on
![Page 3: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/3.jpg)
CommunityorEnterprise:whichedi?onisrightforyou?
vs.
individual
team
![Page 4: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/4.jpg)
Community› DesignedforprogrammerstoQCtheirstandardizeddeliverables› Runsondesktop› Opensource
![Page 5: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/5.jpg)
Enterprise› Designedforteamstocollaborateon› Regulatorysubmissionprepara'on› Standardsmanagement› Con'nuouscompliance
› Runsoncloud› UsedbyFDAandPMDA
![Page 6: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/6.jpg)
DataFitness
![Page 7: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/7.jpg)
MeasureYourDataFitnessIsyourdata"fitforuse"?Measureyour"DataFitnessScore"withthesametoolusedbyFDAandPMDA.Seehowyourdataperformsacrosssixqualitydimensions,includingstandardcompliance,dataquality,andmore.
![Page 8: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/8.jpg)
AssessImpactonReviewThequalityandusefulnessofyourdatahasahugeimpactonthereviewprocess,specificallytheabilityofFDAandPMDAtousestandardizedanalysisandreviewtools.Assessyourdataandlearnhowtoaddresswhatcausesreviewstofail.
![Page 9: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/9.jpg)
AnalyzeDataComposi?onDiggingintoastudyanddis'llingitsmakeupandcontentsarenoproblem…ifyou’reaprogrammer.Fornon-techies,ourtoolmakesitsimpletoassessandviewthecontentsofastudy,andlookforpa\ernsandinconsistencies.
![Page 10: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/10.jpg)
IssueManagement&Tracking
![Page 11: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/11.jpg)
ManageDataIssuesView,organize,andtagvariousdataissues,andassigntasksasneeded.ThisisagreatwaytocommunicateandcollaboratewithCROs,developers,andotherteammemberstoiden'fyandresolveissuesquickly.
![Page 12: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/12.jpg)
TrackandMonitorChangesWanttocheckyourlatestvalida'onagainstanolderone?Ourtoolletsyousee,clearlyandeasily,thechangesthatoccurredsincethelast'meyouvalidatedyourdata(like“TrackChanges”inWord).
![Page 13: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/13.jpg)
CustomStandards&Terminology
![Page 14: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/14.jpg)
ValidateStandards&TerminologyUploadyourownstandardsandterminologyintooursystem,andseewhichareCDISC-compliantandwhichneedwork.Byvalida'ngatthestandardslevel,you’llbegineverystudyknowingyou’reworkingwithclean,compliantmetadata.
![Page 15: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/15.jpg)
TrackChangesinMetadataEach'meCDISCupdatesitsstandardsandterminology,ourtoolwillshowyouwhat’schangedandhowyourcustommetadataneedstobeadjustedforcompliance.Youcanalsotrackdifferentversionsofyourownmetadata.
![Page 16: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/16.jpg)
Define-XML2.0
![Page 17: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/17.jpg)
ExtractMetadata&MergeStandardsScandatasetstoextractdomain,variable,codelist,andvaluelevelmetadataandthenmergeitwithstandards.Finally,scanannotatedCRFstoautoma'callypopulateoriginpagenumbers.
![Page 18: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/18.jpg)
CompareStudiesandVersionsComparetwostudiestoseethedifferencesbetweenthem.Youcanevencomparetwoversionsofthesamestudytoseehowitchangesover'me.
![Page 19: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/19.jpg)
Real-?meValida?onSeeissueshighlightedinreal'meifyoushouldentersomethinginvalidorerroneous.
![Page 20: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/20.jpg)
Reviewer’sGuide
![Page 21: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/21.jpg)
Pre-populateYourContentAutoma'callypre-populateyourtemplatewithcontentpulledfromstudymetadata(Define.xml),trialdesignandtrialsummary,subjectdata,andvalida'onresults.Wetakecareoftheformadngforyou.
![Page 22: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/22.jpg)
ExplainYourDataIssuesStopchasingdownissueexplana'onstwoweeksbeforesubmission.Simplycopythecommentscollectedoverthestudylife-cyclefromIssueManagementandcurateasneeded.
![Page 23: Pinnacle 21 Enterprise - Lex Jansen · Pinnacle 21 Enterprise Facilitang eSubmission Preparaon PhUSE Annual Conference October 11, 2016 “Sponsors whose studies start aer December](https://reader033.vdocuments.us/reader033/viewer/2022042923/5f711f97ba6c5503bc1a110e/html5/thumbnails/23.jpg)
MaxKanevskyFounderandCEOofPinnacle21
Summary› DataFitness› IssueManagementandTracking› CustomStandardsandTerminology› Define-XML2.0› Reviewer’sGuide