pinnacle 21 enterprise - lex jansen · pinnacle 21 enterprise facilitang esubmission preparaon...

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

mkanevsky@pinnacle21.net

Summary›  DataFitness›  IssueManagementandTracking›  CustomStandardsandTerminology›  Define-XML2.0›  Reviewer’sGuide