Using Risk-Based Approaches to Inspection Preparedness
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The 2017 Avoca Industry Report Using Risk-Based Approaches to Inspection Preparedness August 2017
Transcript of Using Risk-Based Approaches to Inspection Preparedness
The2017AvocaIndustryReport
UsingRisk-BasedApproachestoInspectionPreparedness
August2017
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2017AvocaIndustryReportSeries
Eachyear,TheAvocaGroupsurveysindustryprofessionalstounderstandtrendsinclinicaldevelopment,withaparticularfocusonoutsourcingdynamicsandrelationshipsbetweenresearchSponsorsandProviders.
In2017,AvocaissuedtheIndustryReport,whichisahighleveloverviewofkeyresults.
Inaddition,Avocaisissuingaseriesoffollow-upreportsthatexaminespecificareasingreaterdetail,withthisbeingthefirstinthisseries.
IndustryReport
UsingTechnology
inaRisk-Based
Risk-BasedMonitoring
Risk-BasedQuality
Risk-BasedInspection
Risk-BasedOversight
Management
Environment
Preparedness
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NoreproductionoftheinformationinthisreportmaybemadewithouttheexpresspriorwrittenconsentofTheAvocaGroup.Allinquiriesandrequestsforconsentforreproductionanduse,includingintegratingelementsofthisreportintotherecipients’ownworkproducts(e.g.,presentations),shouldbedirectedtoDennisSalottiviaemailatDennis.Salotti@theavocagroup.com.
UsageGuidelines
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Methodology
• AllfieldworkwasconductedbetweenMarchandJuneof2017.
• Atotalof273completedsurveyswerereceivedfromrespondentsrepresenting94individualSponsororganizations.
• Atotalof121completedsurveyswerecollectedfromrespondentsrepresenting49individualProviderorganizations.
• Classificationinformationaboutrespondentsandcompaniestheyrepresentcanbefoundintheappendixofthisreport.
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SummaryofKeyToplineFindings:IndustrySurveyonRisk
• Despitemarkedshiftsinthelandscapeandinregulatoryrequirements,thesedatasuggestthatlittlehaschangedwithrespecttohowtheIndustryisapproachingandmanagingriskassessment.
• Thealignmentofpeopleandprocessesappearstobeasignificantbarrier inmorewidespreadadoptionofrisk-basedtechniquestoclinicaltrialmanagement.
• LargegapscontinuetoexistbetweenhowSponsorsperceivetheirenvironment,andspecificallytheirrelationshipswithProviders,andhowProvidersperceivetheirownperformance.
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KeyFindingsRisk-BasedInspectionPreparedness
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Abouttwo-thirdsofSponsorsandthree-quartersofProvidersreporthavinga“good”or“verystrong”understandingofbestpracticesinrisk-basedinspectionpreparedness.
InspectionPreparedness
FamiliaritywithRisk-BasedApproachestoInspectionPreparedness%havinga“good”or“verystrong”understandingofbestpractices
N:SPONSOR:Total=272;PROVIDER:Total=117Q:Howwouldyourateyourunderstandingofbestpracticesin…?
Sponsors Providers
64% 72%
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Notabledifferencesareobservedbyfunction,withthoseworkinginqualityexpressingahigherlevelofknowledgeaboutrisk-basedinspectionpreparednessrelativetothoseinclinicaloperations.
InspectionPreparedness
83%
58%
96%
62%
Quality ClinicalOperations Quality ClinicalOperations
N:SPONSOR:Quality=60,ClinicalOperations=154;PROVIDER:Quality=26,ClinicalOperations=45Q:Howwouldyourateyourunderstandingofbestpracticesin…?
Quality ClinicalOperations
Quality ClinicalOperations
FamiliaritywithRisk-BasedApproachestoInspectionPreparedness%havinga“good”or“verystrong”understandingofbestpractices
Sponsor Provider
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AmongSponsors,55%reportusingarisk-basedapproachtoinspectionpreparednessinmorethanhalfoftheirtrials;thisgoesupto60%amongProviders.
InspectionPreparedness
Sponsor Provider
FrequencyofUseofRisk-BasedInspectionPreparedness%oftrialsutilizingrisk-basedinspectionpreparednessapproach
N:SPONSOR=224;PROVIDER=78SPONSORQ:Howoftendoyourteamsusearisk-basedapproachto…?SPONSORQ:Howoftendoyouusearisk-basedapproachtoprepareforinspectionsforclinicaltrialswithfunctionsoutsourcedtoFSPs?PROVIDERQ:Howoftendoesyourcompanyusea risk-basedapproachto…?
Morethan75%
51%to75%
25%to50%
1%to24%
Never
33%
22%20%
15%
10%
41%
19%
14%
22%4%
64%ofSponsorsinTop20organizationsuserisk-basedapproachestoinspectionpreparednessinmorethanhalfoftheirtrials.
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FromtheSponsorperspective,theyreportprimarilydrivingtheuseanddesignofrisk-basedapproachestoinspectionpreparedness;Providersseethisasmoreofajointeffort.
InspectionPreparedness
N:SPONSORFullService=76-77;SPONSORFSP=101-106;PROVIDER=75-79SPONSORQ:Forfully-outsourcedclinicaltrials,whogenerallyinitiates/requeststheuseof…?Q:Forclinicaltrialsutilizing functionalserviceproviders,whogenerallyinitiates/requeststheuseof…?Forfully-outsourcedclinicaltrials,towhatextentistheCRO generallyinvolvedindesigningtheapproachto…?Forclinicaltrialsutilizingfunctionalserviceproviders,towhatextentistheFSP generallyinvolvedindesigningtheapproachto…?PROVIDERQ:Whogenerallyinitiates/requeststheuseof…?Towhatextentisyourcompanygenerallyinvolvedindesigningtheapproachto…?
Sponsors Providers
Initiates UseofRisk-BasedInspectionPreparedness
71%82%
21% 17%8% 1%
FullService FSP
Sponsor Mix Provider
54%67%
37% 29%9% 4%
13%
44% 43%
20%
41% 39%
InvolvedinDesignofApproachtoRisk-BasedInspectionPreparedness
Full-service FSP
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SponsorAssessmentofCROs/FSPs ProviderSelf-Assessment
SponsorsexpressmoderatesatisfactionwiththeirProviders’abilitytosupportthemintheuseofrisk-basedapproachestoinspectionpreparedness;Providersexpressmorefavorableself-assessments.
InspectionPreparedness
N:SPONSOR=171;PROVIDER=79SPONSORQ:Overall,howsatisfiedhaveyoubeenwiththeCROs/FSPsyouworkwithintermsoftheir…?PROVIDERQ:Overall,howsatisfiedhaveyoubeenwithyourcompanyintermsofthe…?
SatisfactionwithRisk-BasedApproachtoInspectionPreparedness%selectingresponse
Verysatisfied
Somewhatsatisfied
NeithersatisfiednordissatisfiedSomewhatdissatisfied
Verydissatisfied
8%
36%
29%
21%
6%
30%
36%
24%
9%1%
%satisfied44%
%satisfied66%
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Sponsor Provider
Risk-basedinspectionpreparednessisseenasmostimpactfulonquality;however,impactappearstobeweakoverall– generallyonlyaboutone-thirdorlessofrespondentsindicatethisapproachishavinga‘significant’impact.Sponsorsinfull-servicerelationshipsareseeingagreaterimpact.
InspectionPreparedness
N:SPONSOR:Total=125-127,Full-service=56-57,FSP=67-71;PROVIDER=93-94Q:Howimpactfulhavethefollowingrisk-basedapproachesbeenintermsofincreasing…?
ImpactofRisk-BasedApproachtoInspectionPreparednessonIncreasing…%“extremely”or“veryimpactful”
34%28%
20%
50%
30% 33%
Quality Timeliness ResourceEfficiency
40% 34% 23%
28% 22% 18%
Full-service
FSP
Sponsorsusing:
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Approximatelyhalftotwo-thirdsofrespondentsexpressagreementwiththeideathatregulatoryagenciesapproachinspectionsinawaythatisalignedtoregulatoryguidelinesonrisk-basedapproaches.
InspectionPreparedness
N:SPONSOR=121-137,PROVIDER=36-51Q:Thinkingaboutyourexperiencewithregulatoryinspectionsoverthepast12months,pleaseindicateyourlevelofagreementwitheachstatementbelowusingascaleof1to5,with1indicating"StronglyDisagree"and5indicating"StronglyAgree".
48% 40% 35% 33%45% 53%
11%16%
15% 14%
20% 11%
FDA MHRA EMA FDA MHRA EMA
SomewhatAgree StronglyAgree
AgreementthatInspectionsareConductedtoAligntoRisk-BasedApproachesIndicatedbyRegulatoryGuidance
Sponsor Provider
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KeyTake-AwaysforRisk-BasedInspectionPreparedness
• Overall,SponsorsandProvidersreportafairlygoodunderstandingofbestpracticesinrisk-basedinspectionpreparednesstoday;however,knowledgeisnottranslatingfromexpertsintheQualityFunctiontotheircolleaguesinClinicalOperations.Ø Howcanwecreateacross-functionalcultureofquality?
• SponsorsreportprimarilyinitiatinganddesigningtheseapproachesandareonlymoderatelysatisfiedwithProviders’performanceinthisarea, whileProvidersseethisasajointeffortandassesstheirownperformancemorefavorably.Ø WhatrolecanstandardsofpracticeplayinbringingSponsorsand
Providersintoalignment?
• Theseapproachesareseenashavingthegreatestimpactonquality;however,risk-basedapproachesimpactonqualityisweakoverall.Ø Whatcanyoudotodaytopositivelyinfluencefutureoutcomes?
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AQCProcessMapandNumberofTools
12StepstoICHE6(R2)Compliance
BackgroundandResources
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AssessmentofResourcesandProcessOperations
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ThirdPartyOversight
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IdentificationofCriticalProcessesandData
1
RiskIdentification
3RiskEvaluation
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RiskControl
5
RiskCommunication
9RiskReview
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ProcessImprovement
10RiskReporting
2Documentation
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ABOUTYOUYouwantabroaderperspectiveonclinicaloutsourcingandleadingpracticesinquality.
Youwanttoenableyourteamstodeliverrapid,breakthroughinnovationandthehigheststandardofquality.Youwanttodevelopstrongrelationshipswithpartnersanddecisionmakerswhocanhelp
yourteamandyourbusinesssucceed.
ABOUTUSAvocaisadrivingforcebehindthecontinuousimprovementofoutsourcedclinicalresearch.Asadeveloperofprogressivesolutionstochallengesfacedinclinicalresearch, Avoca
makesatangibledifferencetotheoperationsofpharmaceuticalcompaniesand
clinicalserviceproviders.
Insight.Perspective.Solutions.
AvocaIntegratedConsultingandResearchdeliversafreshperspective— aclear,andneutraltakeonhowtoincreaseefficiency,improvequality,andmitigateriskinclinicaltrialexecutionandmanagement.
Avocapairsbest-in-classresearchcapabilitieswithateamthatunderstandswhattrendsmeanfortheindustryandhowtheyaffectyourday-to-daybusiness.
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Pharmaceutical/Biotech ServiceProvidersAvocaClientList
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AppendixDemographics
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Top20Biopharma
Top50/Mid-sizedBiopharma
OtherMid-sizedBiopharma
Small/SpecialtyBiopharma
Other
Top20Biopharma($10+billionsales)Top50/Mid-sizedBiopharma($2.0- $9.9billionsales)OtherMid-sizedBiopharma($500million- $1.9billionsales)Small/SpecialtyBiopharma(<$500millionsales)MedicalDevicecompany
Other
39%
12%16%
27%
5%1%
SPONSOR:CompanySize
UnitedStates
WesternEurope
Other
SPONSOR:CompanyHeadquarters
81%
12%6%
N=273
N=242
CompanyCharacteristics
PROVIDER:CompanyType
UnitedStates
WesternEurope
Other
PROVIDER:CompanyHeadquarters
CRO
ClinicalServiceProvider
ConsultingCompany
Other
76%
19%5%
N=101
73%
13%
8%6%
N=121
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10yearsorless
Morethan10years
13%
87%
SPONSOR:TimeinIndustry
SPONSOR:PrimaryFunctionalArea
N=242
RespondentCharacteristics
PROVIDER:TimeinIndustry
PROVIDER:PrimaryFunctionalArea
10yearsorless
Morethan10years
9%
91%
N=101
39%21%
12%8%6%4%1%
8%
ClinicalDev't/OperationsQualityAssurance/Control
ExecutiveManagementAllianceMgmt/Partnerships
BusinessDevelopmentMedical/ScientificRegulatoryAffairs
Other
N=121N=273
57%22%
7%3%3%3%1%4%
ClinicalDev't/OperationsQualityAssurance/Control
Procurement/VendorMgmtRegulatoryAffairs
MedicalAffairs/ScientificExecutiveManagement
AllianceMgmt/PartnershipsOther
