MCC

MCC: Site-Generated Performance Metrics v1.0 At-A-Glance

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Foradditionalinformationabo uttheMCC,pleasevisit www.me tricschampion.org 1 MCCSite Generated PerformanceMetrics Version1 At A Glance INTRODUCTION TheValueofStandardizedPerformanceMetrics Biotechnologyandpharmaceuticalorganizationsoptimizeclinicaltrialcycletimesby maintainingfocusoncorecompetencies,byoutsourcingservices,andbyprioritizingthefull utilizationofr esources. 1 Performancemetricsareestablishedbythedrugdevelopmentindustry inordertomeasureandstandardizevariouscomponentsofclinicaldevelopmenttimesand clinicaltrialdeliverables.Byusingmetrics,sponsorsandtheiroutsourcingpartners canmanage andtrackqualityandresources — e.g.people,time,andmoney — inordertogaugethe productivityandefficiencyofeachoverthecourseofaclinicaltrial. Thisallowsthedrug industrytoreducedrugdevelopmenttimesandcosts,anddramaticall yincreaseproductivity whilemaintainingquality.Standardizedperformancemetricsimproveresearch&development strategiesandperformance,bothwithinacompanyandacrosstheentiredrugdevelopment industry. BuildingPartnershipsAroundStandardize dPerformanceMetrics Inordertostandardizemetricsthroughoutthedrugdevelopmentindustry,theMetrics ChampionConsortium(MCC)wasformedbybiotechnology,pharmaceutical,andservice providerorganizationswiththeultimategoalofimprovingtheef ficiencyandeffectivenessof clinicaltrials.Sponsorsandserviceproviderorganizationsbenefitbybeingabletocompare clinicaltrialperformanceacrossallofasponsor'sstudies,eveniftheyutilizemultipleservice providers.Together,sponsorsan dserviceproviderscanreviewperformanceandidentifybest practicescenariosaswellasopportunitiesforimprovement — andthendetermineappropriate actionstepstoimproveperformancefortheprocessesinquestion. Throughoutthemetricsdevelopment andimplementationprocess,theMCCprovidesasafe harborforoverahundredbiotechnology,pharmaceutical,andserviceproviderorganizationsto sharebestpracticesandlearnfromeachotherthroughparticipationinMCClearningforums andcollaborative workgroups. THEMCCMETRICDEVELOPMENTPROCESS TheS takeholder CollaborativeProcess Inlate2014 ,agroupof clinicaltrialsitesestablished withtheinputof sponsors andCROs a setofstandardized performancemetrics that InvestigativeSites shouldusetoassesstheir performanceandtheirinteractionwithotherclinicaltrialstakeholders(e.g.sponsors,CROs,site monitors,etc) .The purpose ofthegroupwasto providerepresentativesfrominvestigativesites anopportunitytoshareex periencesandchallenges,learnaboutwhatsponsors/CROsmeas ure aboutsiteperformance,and definemeasuressitesshouldutilizetoassess theirown p erformance.Additionally,thegroupdevelopedalistof performancemetricstheyshouldask 1 KaitinKI."PushingtheInnovationEnvelope:DrugDevelopmentMetricsandtheChangingDynamicsof PharmaceuticalR&D."Presentedatthe6thAnnualPharmaceut icalMetricsEvent:DrivingQuality,Cost,& Time;October16 – 18,2007;Cambridge,MA.

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