research professionals resource management: to … · cincinnati children’s hospital medical...

ClinicalResearchProfessionalsResourceManagement:To

centralizeornot?

October25,2016

Disclaimer

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PresenterIntroductions

Theinformationpresentedisbasedonthepresenters’experienceandisnotnecessarilyrepresentativeofHuron’sviewpoint.

MindyMuenich

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MindyiscurrentlyadirectorwithHuronConsultingGroupintheResearchServicespracticearea.Mindyhasadiversebackgroundinthehealthcareandresearchindustryincluding25yearsofclinicalandresearchoperationsmanagement,businessdevelopment,physicianservicesandqualityprocessimprovement.Recentclientprojectsincludeclinicalresearchbillingprocessredesign,researchoperationsinfrastructureandoptimizationandCRMSimplementation.PriortoHuron,MindywastheDirectorofClinicalandTranslationalResearchOfficeatCincinnatiChildren’sHospitalMedicalCenterandUCHealth.

NirmalaThevathasan

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NirmalaiscurrentlyamanagerwithHuronConsultingGroupintheResearchServicespracticearea.Nirmalahasover17yearsofexperienceinhealthcareandclinicalresearch.Shespecializesinclinicalresearchoperationsandmanagement,strategicplanning,researchcomplianceandbusinessprocessdevelopmentandimprovement.Duringherconsultingtenure,shehashelpeduniversities,hospitalsandcancercenterswithclinicalresearchoperationaloversightandinfrastructureplanning.PriortoHuron,NirmalawastheAssociateDirectoroftheClinicalTrialsOffice(CTO)atTheChildren’sHospitalofPhiladelphia(CHOP).

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Objectives

• IdentifythedifferentmodelsforClinicalResearchProfessionalsstaffing

• Describethecriteriafordeterminingwhetheracentralizedapproachtoclinicalresearchstaffingisappropriateforanorganization

• Describemethodsforcostrecoveryofcentralizedclinicalresearchresources

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Agenda

ElementsofOrganizationalSuccess

CurrentChallengesinClinicalResearch

StaffingModels

ConsiderationsforDetermininganAppropriateStaffingModel

CostRecoveryforaCentralizedModel

CaseStudy

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Agenda



StaffingModels



CaseStudy

StrategiesforaSuccessResearchProgram

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• Beforechoosingandimplementingastaffingmodel,aninstitutionshouldfirstconsideritsstrategicandfinancialgoalsforengaginginresearch

Vision

ProcessDocuments

ExecutionTools

Policy

StandardOperatingProcedures

StrategicGoals

ChecklistsTemplatesForms

KeySuccessandChallengeFactorstotheOperationalHealthofaResearchPortfolio

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Elements Contributing to

Overall Effectiveness and Efficiency

Organizational Structure

People

Performance Measurement

Technology

Business Process

Elements Contributing to

Overall Effectiveness and Efficiency

Organizational Structure

People

Performance Measurement

Technology

Business Process

OrganizationalStructure• Whoisresponsibleformakingdecisions?• Aretheyauthorizedtomakedecisions?People• Doyouhaveenoughpeople?• Doyouhavetherightpeople?Process• Clearlydefinedanddocumented?Technology• Manualvs.Automated?PerformanceMeasurement• Areyoucapturingrelevantdatapoints?• Doyouknowwhatthedataistellingyou?

OrganizationalStructureandGovernance

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• Howaninstitutionisgovernedandstructuredhasadirectimpactonitsabilitytoachievestrategicinitiatives

• Importanttoconfirm,formalizeandsocializethegovernancemodel• Whiletheselargergovernancequalificationsareimportant,effective

managersrelyonmorefundamentalconcepts,suchas:o Establishingauthoritytoeffectchangeateachleveloftheorganization

o Buildingaculturethatembraceschange

o Balancingtheresearchvisionwithanunderstandingofwhatis

financially/operationallyrequiredtoachievethatvisionacrosstheportfolio

“Itisnotthestrongestofthespeciesthatsurvives,northemostintelligent,buttheonemostresponsivetochange.”– CharlesDarwin

OrganizationalStructureandGovernance

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GovernanceStrategies Benefits• Createtargetedcommitteesand

empowerthemtoaddressoperationalissues

• Empowerthecommitteestodevelopguidingprinciplesandastrategicplan,includingadefinitionof“success”inclinicalstudyperformance

• Clearerinstitutionalleadershipandoversight

• Anestablishedbodythatisabletoreviewresults,suggestcorrectionsandguidedecisions

• ImprovedaccountabilitythatengagesmorethanjusttheInvestigator

• Facilitatedcommunicationbetweenresearchersandinformationsources

• Buildsconsensusamongststakeholders

People

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• Asorganizationsexpand/contract,asignificantchallengecanbehavingtherightpeopleintherightpositionsandprovidingtheappropriateresourcestosuccessfullyexecutetheirrole.Thefollowingstepswillhelpensureyourpeoplearesuccessful:

Clearrolesandresponsibilitiestoguidedailyoperationsandemphasizecustomerservice

Adequateresourcestoimplementthefeasibilityprocess

Sufficienttimelinestomanagewithlimitedresources

Experiencedpersonnelexecutingtheirresponsibilitieswithsufficienttrainingtoperformtheirrole

Experiencedpersonnelexecutingtheirresponsibilitieswithsufficienttrainingtoperformtheirrole

Process

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• Whenimplementingachangetoanexistingclinicalresearchprocess,someofthechallengesinclude:o Standardizingprocessesacrosstheorganizationandupdatingannually

o Simplifyingprocesseswhereverpossible

o Complexityleadstoerrorsandrework,ifyouareexperiencinghighlevelsofeither,itispossibleyourprocessesaremorecomplicatedthantheyneedtobe

• Formalizeprocessesthroughpoliciesandstandardoperatingprocedures(SOPs)

• CommunicateandtrainentireresearchcommunitytoensurepoliciesandSOPsareunderstood

Technology

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• Whenevaluatingnewsystems,createworkflowsandaninventoryofcurrentsystems(includingthepurposeandendusers)

• Conductagapanalysismappingtheprocessestothesystemstodetermineadditionalsystemandprocessneeds

• Identifyclearrequirementstoensurethesystemfitsthebusinessneed• Integratesystemswhenpossibletoeliminateduplicatework• Determinereportingneedsandsourcesofdata• Ensuretherightpeoplehavetherightaccesstotherightdata• Createaformalprocessforrequestingaccesstothesystem(s)

PerformanceMeasurement

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• Standardbusinessprocessesanddatasourcesleadtoan“applestoapples”comparisonformanagementdecisionmaking.Examplesinclude:o Identifyingthescopeoftheportfoliobeingmeasured(numberandtypesof

studies)

o Outliningandcontrollingvariableworkloadrequirementsfordifferentstudytypes(complexclinicaltrialversusaretrospectivechartreview)

o Collectingmetricsonastudy‐by‐studybasis

o Ensuringperformancemetricsarereliableandvalid

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Agenda



StaffingModels



CaseStudy

ExternalEconomicandRegulatoryPressures

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CurrentChallengesInClinicalResearch

• Changestoresearchfundinglandscapedueto:o DecreasingNIHdollars,federalbudgetdeficitso Tighterpharmarequirements,globalizationofclinicaltrialso Increaseinformationofco‐operativegroups,sub‐awardfunding

• Increasingregulatoryandreportingrequirements(CMS,NIH)o Clinicalresearchbillingo Conflictsofinterest

• Globalizationoftheresearchmarketandpharmaceuticaloutsourcingo Increasedlocal,nationalandinternationalcompetition

• Increasedcomplexityofstudyprotocols

InternalDynamicsintheResearchEnterprise

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• Movingtowardssharedservicemodels• Centralizingadministrativeserviceoperationsforresearch• Managingandrecoveringthefixedcostsofcentralizedstudy

coordinatorsorotherclinicalstaffsupportingPrincipalInvestigators• Desiretoimproveworkflow,timetoenrollmentandcostrecovery• Implementingpoliciesandproceduresinresponsetoexternal

challengesbutimplementedwithlimitedcommunicationandtrainingresources

• Technologysystemschosenandimplementedrequirealevelofintegrationwithothersystemstodeliverdesiredsolutions

ImpactoftheseChallenges

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• Doingmorewithless• Studiesaremoreexpensivetoconduct,compressingsitebudgets• Morestudiespercoordinator• Increasingregulatoryrequirementsmeansmorepaperwork• Pressuretofullyenrolloratminimum,enrollmore…andfaster• Personnelfunctioninginmultipleroles

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Agenda



StaffingModels



CaseStudy

CRPs

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StaffingModels

ClinicalResearchProfessionals(CRPs)• ClinicalResearchNurses• ClinicalResearchCoordinators• ClinicalResearchAssociates• DataManagers• RegulatoryCoordinators

StaffingModelTypes

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StaffingModels

Centralized De‐Centralized Hybrid• TheCRPsresidewithin

acentraloffice(usuallyaClinicalTrialsOffice)andareassignedtostudiesthroughouttheinstitution

• Reporttothecentralofficeresearchmanagerand/ormedicaldirector

• TheCRPsresidewithintheclinicaldepartments

• ReporttoaPrincipalInvestigatorand/oradepartmentresearchmanageroradministrator

• AcombinationofdepartmentresourcessupplementedbycentralizedCRPresources

• Matrixreportingstructure

Poll

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StaffingModels

Whatisthestaffingmodelatyourinstitution?1. Centralized2. De‐Centralized3. Hybrid

CentralizedStaffingModel

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StaffingModels

Pros Cons• Clearandestablishedreportinglines.• Experienced,qualifiedmanagement

team• Consistentprocesses• Cross‐coverageofstudies• Teamenvironment• Consistenttrainingandeducation

• Generalistapproach– needtobeadaptabletovariousdepartmentsandstudies

• Lessinvestigatorbuy‐in/feelingofownership

• Infrastructurecoststomaintain

DecentralizedStaffingModel

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StaffingModels

Pros Cons• Departmentownership

o Directreportingtoinvestigatorordepartment

• Therapeuticspecialization• Closegeographicproximityto

investigatorand/ordepartment.o VisibilityofCRP

• Blurredreportingstructure.• Limitedcross‐coverage• Inconsistenttrainingandeducation• Varyingprocessesacross

departments• Difficulttomeasureinstitutional

performancemetrics

HybridStaffingModel

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StaffingModels

Pros Cons• Allowsforexpertsintherapeutic

areas• Leveragedepartmentalandcentral

resources(coverageforPTO,highvolume,generalizebestpractices)

• Flexibleandadaptabletospecificresearchneeds

• Departmentvs.centralallegiance• Multiplereportingstructures• Varyingprocessesacross

departmentsandthecentraloffice• Difficulttomeasureinstitutional

performancemetrics

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Agenda



StaffingModels



CaseStudy

KeyConsiderations

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DetermininganAppropriateStaffingModel

• OrganizationalStructure• FinancialResources• ComplianceRisks• TrainingandEducation• ResearchPortfolio

OrganizationalStructure

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1. Isresearchakeycomponentoftheorganization’smission?2. Whodeterminesstrategicgoalsforresearch?3. Whohasauthoritytomakedecisions?4. Arethereclearinstitutionalprocesses?5. Whatisthemotivationforconductingresearch?6. Istheorganizationadaptabletochange?

FinancialResources

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1. Whatdoesyourresearchportfoliolooklike?– Industry,federal,internal,etc.

2. Doyouhavepoliciesthatgovernresearchfunding?– Aretheredesignatedinstitutionalfundsforresearchinfrastructure?– Doesyourinstitutionallowforuseofresidualdollarstosupport

infrastructure?3. Ifcentralized,isfullcostrecoveryexpected?

ComplianceRisks

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1. Doesyourinstitutionhavearesearchcomplianceprogram?2. Whatisyourinstitution’slevelofrisktolerance?3. Havetherebeeninstancesofnon‐compliance?

TrainingandEducation

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1. Doesyourinstitutionhaveacentralizedtrainingandeducationprogramforclinicalresearch?

2. Isthereongoingevaluationandenhancementoftrainingopportunities?

3. Istheresufficientaccesstotrainingresources?4. Whohastheresponsibilityforprovidingtrainingandeducation?5. Istherecentralizeddocumentationoftraining?

ResearchPortfolio

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1. Whatisyourstudyvolume?2. Whattypeofresearchisprominent?3. Whoareyourprimaryfundingsponsors?

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Agenda



StaffingModels



CaseStudy

Methods

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SalaryAllocation FeeforService• RecommendedforCRPsstaffed

100%onfederallyfundedgrants• Ideallyforprojectsmorethanone

yearinduration• Designatedpersonneltoa

department

• RecommendedforCRPspartiallystaffedonindustrysponsoredprojectsandfederallyfundedgrants

• Projectsthataretypicallylessthanoneyearinduration

Implementation

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• Calculatingrates• Designingprocesses• Creatingatimemanagementsystem

CalculatingRates

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• Basedonactualsalarydata• Incorporatenon‐productivetime

o PTOo Trainingandeducationo Departmentactivities(e.g.committeeinvolvement,QAactivities)

• Planforannualincreases• Documentaclearandwrittenmethodology

o Facilitatesbuy‐ino Neededforgrantjustification

DesigningProcesses

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• Requestforsupport• Contractforservices• Assignments• Training• Billing• Expectations• Escalationprocess• SupportingSOPs

CreatingTimeManagementSystem

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• Tracktimespentperprojecto Manualtimesheetso Weeklyreporto Electronicsystem

• CTMS• Projectspecific• Recommend15‐20minuteincrements

• Allowforreviewandapprovalby“customer”• Consistentwithinstitutionaleffortreportingprocesses• Considerreportingneeds

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Agenda



StaffingModels


CaseStudy


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• Anacademicmedicalcenteraffiliatedwithauniversity• OriginalStructure>Hybrid• RedesignedStructure>Centralized• Whyandhowtheytransformedtheclinicalresearchenterprise

CaseStudy

• Membersoftheresearchcommunityperceivethatresearch isnotconsideredapriorityacrosstheorganization

• Funding isaconstantchallengeandisverycompetitive• Thereviewprocess forcommerciallysponsoredstudiesisnot

meetingexpectations• Thereisnoconsistentcommunicationwiththeinvestigatorsorstudy

teamsregardingthestatusoftheirstudy

Challenges

CaseStudy

• Technologyisdrivingprocessesratherthanprocessesbeingdefinedandsupportedbytechnology

• Data isdifficulttoobtain;thereisinsufficientfinancialdatatodeterminefundsflowforresearch

• Thecurrentinfrastructureisinsufficienttomanagethecurrentvolumeandtypeofresearchactivities

• Thereisalackofwell‐definedresearchprocesseswhichcontributestoinconsistenciesacrossdepartmentsandorganizations

Challenges

CaseStudy

RedesignedInfrastructure– Centralized

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CaseStudy

• Enhancedcommunications• Collaborativeandefficientprocessespre‐ andpost‐award

– Coverageanalysis,budgeting,contracting,regulatory,financialmanagementandreconciliation

• Eliminatesduplication• Decreasesbillingrisks• Providesaunifiedapproachandsinglepathwayforinvestigators

Benefits

CaseStudy

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ConcludingThoughts

• Wehavesharedthreestaffingoptionstosupporttheclinicalresearchenterpriseo Thereisno“onerightanswer”o Onesizedoesn’tfitallo Needtodeterminewhatworksforyourinstitution

• Ifyouareconsideringacentralizedorhybridmodel,engagestakeholdersearlyandoftenintheplanningprocess

• Regardlessofyourstaffingmodel,standardizedprocessesarecriticaltosuccessfullyconductingresearch

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Questions?

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ContactInformation

• MindyMuenich– [email protected]– Tel.:513‐207‐0626

• NirmalaThevathasan– [email protected]– Tel.:267‐838‐1306