pinnacle 21 enterprise - lex jansen · pinnacle 21 enterprise facilitang esubmission preparaon...
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Pinnacle21EnterpriseFacilita'ngeSubmissionPrepara'onPhUSEAnnualConferenceOctober11,2016
“SponsorswhosestudiesstartaDerDecember17,2016,mustsubmitdatainthedataformatssupportedbyFDAandlistedintheFDADataStandardsCatalog.ThisappliestoNDAs,BLAs,ANDAs,andsubsequentsubmissionstothesetypesofapplica'ons.”
-FDAU.S.FoodandDrugAdministra'on
CommunityorEnterprise:whichedi?onisrightforyou?
vs.
individual
team
Community› DesignedforprogrammerstoQCtheirstandardizeddeliverables› Runsondesktop› Opensource
Enterprise› Designedforteamstocollaborateon› Regulatorysubmissionprepara'on› Standardsmanagement› Con'nuouscompliance
› Runsoncloud› UsedbyFDAandPMDA
DataFitness
MeasureYourDataFitnessIsyourdata"fitforuse"?Measureyour"DataFitnessScore"withthesametoolusedbyFDAandPMDA.Seehowyourdataperformsacrosssixqualitydimensions,includingstandardcompliance,dataquality,andmore.
AssessImpactonReviewThequalityandusefulnessofyourdatahasahugeimpactonthereviewprocess,specificallytheabilityofFDAandPMDAtousestandardizedanalysisandreviewtools.Assessyourdataandlearnhowtoaddresswhatcausesreviewstofail.
AnalyzeDataComposi?onDiggingintoastudyanddis'llingitsmakeupandcontentsarenoproblem…ifyou’reaprogrammer.Fornon-techies,ourtoolmakesitsimpletoassessandviewthecontentsofastudy,andlookforpa\ernsandinconsistencies.
IssueManagement&Tracking
ManageDataIssuesView,organize,andtagvariousdataissues,andassigntasksasneeded.ThisisagreatwaytocommunicateandcollaboratewithCROs,developers,andotherteammemberstoiden'fyandresolveissuesquickly.
TrackandMonitorChangesWanttocheckyourlatestvalida'onagainstanolderone?Ourtoolletsyousee,clearlyandeasily,thechangesthatoccurredsincethelast'meyouvalidatedyourdata(like“TrackChanges”inWord).
CustomStandards&Terminology
ValidateStandards&TerminologyUploadyourownstandardsandterminologyintooursystem,andseewhichareCDISC-compliantandwhichneedwork.Byvalida'ngatthestandardslevel,you’llbegineverystudyknowingyou’reworkingwithclean,compliantmetadata.
TrackChangesinMetadataEach'meCDISCupdatesitsstandardsandterminology,ourtoolwillshowyouwhat’schangedandhowyourcustommetadataneedstobeadjustedforcompliance.Youcanalsotrackdifferentversionsofyourownmetadata.
Define-XML2.0
ExtractMetadata&MergeStandardsScandatasetstoextractdomain,variable,codelist,andvaluelevelmetadataandthenmergeitwithstandards.Finally,scanannotatedCRFstoautoma'callypopulateoriginpagenumbers.
CompareStudiesandVersionsComparetwostudiestoseethedifferencesbetweenthem.Youcanevencomparetwoversionsofthesamestudytoseehowitchangesover'me.
Real-?meValida?onSeeissueshighlightedinreal'meifyoushouldentersomethinginvalidorerroneous.
Reviewer’sGuide
Pre-populateYourContentAutoma'callypre-populateyourtemplatewithcontentpulledfromstudymetadata(Define.xml),trialdesignandtrialsummary,subjectdata,andvalida'onresults.Wetakecareoftheformadngforyou.
ExplainYourDataIssuesStopchasingdownissueexplana'onstwoweeksbeforesubmission.Simplycopythecommentscollectedoverthestudylife-cyclefromIssueManagementandcurateasneeded.
MaxKanevskyFounderandCEOofPinnacle21
Summary› DataFitness› IssueManagementandTracking› CustomStandardsandTerminology› Define-XML2.0› Reviewer’sGuide