The 2017 Avoca Industry Reporttheavocagroup.com/wp-content/uploads/2017/09/2017... · 8 $52.5B $56.4B $60.7B 59% 65% 59% 66% 69% 61% 2015 2016 2017 R&D Spend (in billions)* Current

The2017AvocaIndustryReport

EvaluatingandManagingRiskinClinicalTrials

August2017

2

Introduction

Eachyear,TheAvocaGroupsurveysindustryprofessionalstounderstandtrendsinclinicaldevelopment,withaparticularfocusonoutsourcingdynamicsandrelationshipsbetweenresearchSponsorsandProviders.

Inthisyear’sindustryreview,AvocaexaminedhowSponsorsandProvidersassessandmanageriskinclinicaltrials.Thistopicisacontinuationofresearchfirstconductedin2013;longitudinalcomparisonsofkeyvariablesarenoted,whereapplicable.

Thisreportsummarizesthekeyfindingsfromourresearch.

3

NoreproductionoftheinformationinthisreportmaybemadewithouttheexpresspriorwrittenconsentofTheAvocaGroup.Allinquiriesandrequestsforconsentforreproductionanduse,includingintegratingelementsofthisreportintotherecipients’ownworkproducts(e.g.,presentations),shouldbedirectedtoDennisSalottiviaemailatDennis.Salotti@theavocagroup.com.

UsageGuidelines

4

2017AvocaIndustryReportSeries

This2017AvocaIndustryReportrepresentsasummaryofthekey,high-levelfindingsobservedamongSponsorsandProviders.

Additionally,Avocawillissueaseriesoffollow-upreportsthatexaminespecificareas,suchasrisk-basedqualitymanagementandusingtechnologytosupportrisk-basedapproaches,ingreaterdetail.

IndustryReport

UsingTechnology

inaRisk-Based

Risk-BasedMonitoring

Risk-BasedQuality

Risk-BasedInspection

Risk-BasedOversight

Management

Environment

Preparedness

5

Methodology

• AllfieldworkwasconductedbetweenMarchandJuneof2017.

• Atotalof273completedsurveyswerereceivedfromrespondentsrepresenting94individualSponsororganizations.

• Atotalof121completedsurveyswerecollectedfromrespondentsrepresenting49individualProviderorganizations.

• Classificationinformationaboutrespondentsandcompaniestheyrepresentcanbefoundintheappendixofthisreport.

6

StateoftheIndustryClinicalOutsourcingSpend&KeyRelationshipHealthMeasures

7

FullService41%FSP

59%

SPONSOR:OutsourcingModel SPONSOR:FSPOutsourcedFunctions79%

67%

66%

50%

49%

47%

46%

30%

27%

26%

22%

21%

18%

FieldMonitoring

ClinicalTrialManagement

DataManagement

MedicalWriting

StudyStartup

Biostatistics

SiteIdentificationandSelection

EarlyPhase

Pharmacovigilance/SafetyReporting

MedicalMonitoring

ClinicalSupplyManagement

AncillarySupplyManagement

Regulatory

StateoftheIndustry

Nearly60%ofrespondentsfromSponsororganizationsreportprimarilyusingafunctionalapproachtooutsourcing– fieldmonitoring,clinicaltrialmanagementanddatamanagementarethemostfrequentlyoutsourcedfunctions.

N:SPONSOR=270/158Q:Pleaseselecttheoutsourcingmodelthatbestrepresentsyourcompany’sapproachtoclinicaldevelopmentoutsourcing.If bothapproachesareequallyutilized,pleaseselecttheonethatyouhavethemostexperiencewithatyourcurrentcompany.Q:Youindicatedthatyourcompanyusesafunctionaloutsourcingapproach.Whichfunctionsareoutsourcedinthisway?

8

$52.5B $56.4B $60.7B

59% 65%

59%

66% 69%

61%

2015 2016 2017

R&DSpend(inbillions)* CurrentOutsourcedSpend OutsourcedSpend3YearsFromNow

Today,about60%ofclinicaldevelopmentspendisoutsourced,whichalignstospendlevelsobservedoverrecentyears.Thoughrespondentshaveanticipatedmodestincreasesinoutsourcedspending,thishasnotcometofruition.

StateoftheIndustry

N:SPONSOR:2015=123-131,2016=112-116,2017=273Q:Approximatelywhatpercentageofyourcompany’sspendonclinicaldevelopmentwasoutsourcedin2016,andwhatdoyouexpectthepercentagewillbe3yearsfromnow?

SPONSOR:ProportionofOutsourcedClinicalDevelopmentSpend

*Source:WilliamBlairEquityResearch(April2016);2016/2017spendestimatedbasedonprojected7-8%CAGRannually.

9

47%

52%

51%

44%

28%

16%

15%

10%

YourRELATIONSHIPSwithproviders

TheOVERALLWORKthathasbeendoneforyoubyproviders

TheQUALITYdeliveredby

providers

TheVALUEreceivedforthemoneyspent

withproviders

SomewhatSatisfied VerySatisfied

40%

35%

41%

32%

52%

61%

53%

61%

NotablegapswereobservedbetweenSponsors’ratingsofsatisfactionwithkeyindicatorsofrelationshiphealthrelativetothoseofProviders.

StateoftheIndustry

N:SPONSOR=255-265;PROVIDER=117-120Q:Thinkingaboutyourexperiencesin2016,howsatisfiedareyouwith…

SPONSOR PROVIDER

3.9 (-.5) 4.4

3.6 (-.9) 4.5

3.6 (-.8) 4.4

3.4 (-1.1) 4.5

YourRELATIONSHIPSwithsponsors

TheOVERALLWORKdeliveredtosponsors

TheQUALITYdeliveredtosponsors

TheVALUEdeliveredtosponsors

MeanRatings:1=VeryDissatisfied;5=VerySatisfied

OverallAssessment ofRelationshipHealth:Sponsorsvs.Providers

10

StateoftheIndustry

N:AllSponsors=255-265,Full-Service=106-109,FSP=147-154Q:Thinkingaboutyourexperiencesin2016,howsatisfiedareyouwith…

MeanRatings:1=VeryDissatisfied;5=VerySatisfied

OverallAssessmentofRelationshipHealth:SponsorsUsingFull-Servicevs.FSPOutsourcingModel

AllSponsors Full-Service FSP

YourRELATIONSHIPSwithproviders 3.9 3.9 3.9

TheOVERALLWORKthathasbeendoneforyoubyproviders 3.6 3.6 3.6

TheQUALITYdeliveredbyproviders 3.6 3.5 3.6

TheVALUEreceivedforthemoneyspentwithproviders 3.4 3.4 3.3

AmongSponsorsusingdifferentoutsourcingmodels,perceptionsofkeyrelationshipindicatorswerecomparable.

11

Thesegapshavepersistedovertime,anddonotappeartoshowsignsofnarrowing.

StateoftheIndustry

2015N:SPONSOR=148-152,PROVIDER=88-90;2016N:SPONSOR=104-105,PROVIDER=56-60;2017N:SPONSOR=255-265;PROVIDER=117-120.Q:Thinkingaboutyourexperiencesin2016,howsatisfiedareyouwith…

3.8 3.6 3.9

4.3 4.2 4.4

012345

2015 2016 2017

Relationship

3.6 3.6 3.6

4.3 4.3 4.5

012345

2015 2016 2017

OverallWork

3.6 3.5 3.6

4.3 4.3 4.4

012345

2015 2016 2017

Quality

3.3 3.4 3.4

4.4 4.04.5

012345

2015 2016 2017

Value

TrendinOverallAssessment ofRelationshipHealthSponsor Provider

12

RiskAssessmentPrevalenceandPracticeofRiskAssessmentinClinicalResearch

13

10%

4%

2%

19%

16%

11%

23%

20%

12%

13%

24%

35%

35%

36%

40%

In-house

Full-service

Never 1%to24% 25%to50% 51%to75% Morethan75%

SPONSOR

RiskAssessment

SystematicriskassessmentsarebeingutilizedsimilarlybySponsorsforin-houseandfullyoutsourcedtrials- between50%and60%saytheyaredoingthisinatleasthalfoftheirtrials.Providersshowevengreaterutilization.

N:SPONSORIn-house=231/Full-service=92;PROVIDER=92SPONSORQ:Howoftendoyourcompany’sproject/programteamsuseasystematicriskassessmentprocessfortrialsmanagedandconductedbyin-houseteams?SPONSORQ:Howoftendotheproject/programteamswithwhichyouwork(includingtheCROpartners)useasystematicriskassessmentprocessforoutsourcedclinicaltrials?PROVIDERQ:Approximatelyhowoftenisasystematicriskassessmentprocessemployedforclinicaltrialsconductedbyyourcompany?

PROVIDER

FrequencyofRiskAssessment

%oftrials:

SPONSOR

14

Always18%

Frequently28%

Occasionally

23%

Rarely14%

Never

17%

SponsorFSPModelRiskAssessmentUtilization

61%55%55%52%51%

40%38%36%33%32%31%29%

22%

ClinicalTrialManagement

FieldMonitoring

SiteIdentificationandSelection

MedicalMonitoring

DataManagement

StudyStartup

Biostatistics

Pharmacovigilance/SafetyReporting

Regulatory

MedicalWriting

EarlyPhase

AncillarySupplyManagement

ClinicalSupplyManagement

RiskAssessmentAmongSponsorsutilizingafunctionaloutsourcingmodel,46%reportthatthey“always”or“frequently”performriskassessments.Assessmentsareusedmostoftenwithintheoutsourcedfunctionsofclinicaltrialmanagement,fieldmonitoringandsiteidentificationandselection.

N:SPONSORFSP(allfunctionsaggregated)=158;FSPFunctions=21-104SPONSORQ:Youindicatedthatyourcompanyusesafunctionaloutsourcingmodel.Howoftendothefollowingoutsourcedfunctionsparticipateinasystematicriskassessmentprocessforyourtrials?

SponsorFSPModel%“always”or“frequently”usingriskassessment

15

65% 67% 62%

39%

55%

35%

In-house Full-service FSP

RiskAssessment

Regardlessofoutsourcingmodel,Top20Sponsororganizationsareusingriskassessmentsmorefrequentlythanarethoseinsmallerorganizations.ThistrendhasheldtruesinceAvoca’sinitialassessmentofriskbehaviorin2013.*

N:SPONSORIn-house:Top20=89,Other=142;Full-service:Top20=36,Other=56;FSP(allfunctionsaggregated);Top20=61,Other=82SPONSORQ:Howoftendoyourcompany’sproject/programteamsuseasystematicriskassessmentprocessfortrialsmanagedandconductedbyin-houseteams?SPONSORQ:Howoftendotheproject/programteamswithwhichyouwork(includingtheCROpartners)useasystematicriskassessmentprocessforoutsourcedclinicaltrials?SPONSORQ:Youindicatedthatyourcompanyusesafunctionaloutsourcingmodel.Howoftendothefollowingoutsourcedfunctionsparticipateinasystematicriskassessmentprocessforyourtrials?

FrequencyofRiskAssessment%usingassessmentinmorethanhalfoftrials(forin-houseandfull-service)

%using“always”or“frequently”(forFSP)

Top20Sponsors AllOtherSponsors

*The2013AvocaIndustryReportcanbefoundhere:http://theavocagroup.com/wp-content/uploads/2016/01/The_2013_Avoca_Report.pdf

16

Sponsorsaremostlikelytoreportthattheyinitiate riskassessments,especiallywithinanFSPmodel;however,theCROorFSPisatleastequallylikelytobeinvolved intheprocess.FromtheProviderpointofview,respondentsreportthattheirorganizationsaretypicallyinitiatingand engaginginthisprocess.

RiskAssessment

N:SPONSORFullService=95/95;SPONSORFSP=124/123;PROVIDER=108/93SPONSORQ:Forfully-outsourcedclinicaltrials/Fortrialsutilizingfunctionalserviceproviders,whomostofteninitiates/requestsasystematicriskassessment?SPONSORQ:Forfully-outsourcedclinicaltrials/Forclinicaltrialsutilizingfunctionalserviceproviders,towhatextentistheCRO/FSPgenerallyinvolvedinthesystematicriskassessment?PROVIDERQ:Whogenerallyinitiates/requests asystematicriskassessment?PROVIDERQ:Towhatextentisyourcompanygenerallyinvolvedinthesystematicriskassessment?

Sponsors Providers

InitiatesAssessment

44%

73%

28% 16%

27% 11%

FullService FSP

Sponsor Mix Provider

15%

49% 62%

44% 23%

7%

7% 30%

63%

5%

39% 56%

InvolvedinAssessment

Full-service FSP

17

Easy

SlightlyDifficult

SomewhatDifficult

VeryDifficult

Onlyaboutone-thirdofrespondentsindicatethatgainingalignmentonriskis“easy”fromaninternalperspective.Evenfewersaythisisthecasewhenattemptingtogainalignmentwithexternalparties.

RiskAssessment

N:SPONSOR=224/210;PROVIDER=98/92Q:Ingeneral,howdifficultisittogainagreementabouttheprobabilityandimportanceofthevariousrisksassociatedwithclinicaltrialconduct…?

34%

42%

19% 5%

SPONSOR:InternallyEasy

SlightlyDifficult

SomewhatDifficult

VeryDifficult

PROVIDER:InternallyDifficultyGainingAlignmentonRisk…

37%

48%

13% 2%

23%

48%

24% 5%

SPONSOR:WithProviders PROVIDER:WithSponsors

14%

55%

26%

5%

18

Despitenotedgapsinhowthetwoaudiencesalignonrisk,SponsorsandProvidersaregenerallyinsyncregardingwhen theyareperformingriskassessments.Two-thirdsaredoingsopriortotrialstart,approximatelyhalfaredoingsoduringstart-upandthree-quartersaredoingsothroughoutthetrial.

RiskAssessment

N:SPONSOR=248;PROVIDER=109Q:Whenisriskassessmentperformed?

66%

52%

76%67%

60%

80%

PriortoTrialInitiation

DuringStart-up

ThroughouttheTrial

WhenRiskisAssessedSponsor Provider

19

Bothaudiencesarealsowellalignedonthe“nature”ofriskassessments–approximatelyhalfareusingahybridapproachofquantitativeandqualitativemethods,whilemostothersprimarilyapproachqualitatively.

RiskAssessment

N:SPONSOR=240;PROVIDER=107Q:Istheriskassessmentprocessprimarilyqualitative(e.g.,risksidentifiedanddiscussed),orquantitative(e.g.,probabilitiesandconsequencesofspecificrisksestimatedquantitatively)?

HowRiskisAssessed

SPONSORPrimarilyqualitative

Approximatelyequalmix

Primarilyquantitative

Itdepends

PROVIDER

38%

46%

8% 8%

41%

47%

9% 3%

20

Riskstodataquality,protocolandsitecompliance,enrollmentandsafetyandtimelinesaremostprevalentinformalriskassessmentsbybothSponsorsandProviders.

RiskAssessment

N:SPONSOR=242;PROVIDER=108SPONSORQ:Whenasystematicriskassessmentisperformedforyourcompany'sprojects,whichofthefollowingrisksaretypicallyformallyassessed?Risksto…PROVIDERQ.Whenasystematicriskassessmentisperformedforprojectsconductedbyyourcompany,whichofthefollowingrisksaretypicallyformallyassessed?Risksto…

%ofSponsors

%ofP

rovide

rs

TypesofRiskAssessed%indicatingthatriskisformallyassessed

Patient enrollment

Drug/device supply-related

Timeline

Budget

Data quality

Site compliance

Clinical trial subject safety

Rights of clinical trial subjects/ethics Vendor

performance

Reputation

Resourcing

Protocol compliance

0%

20%

40%

60%

80%

100%

0% 20% 40% 60% 80% 100%

2013:PatientenrollmentwasthetopselectionamongbothSponsorsandProviders

21

Today,probability,timinganddetectabilityarelessfrequentlyassessedrelativetoseverityandabilitytoproactivelyreduceriskandconsequences.

RiskAssessment

N:SPONSOR=235;PROVIDER=101SPONSORQ:Whenasystematicriskassessmentisperformedforyourcompany'sprojects,whatfeaturesofeachriskaregenerallyassessed?PROVIDERQ.Duringriskassessments,whatfeaturesofriskaregenerallyassessed?

77%

75%

74%

66%

51%

49%

86%

77%

84%

75%

52%

61%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Severity/levelofharm

Abilitytoproactivelyreducerisk

Abilitytoreduce/remediateconsequences

Probability

Potentialtimingofriskbecominganissue

Detectability

Sponsor Provider

FeaturesofRiskAssessedICHE6R2RiskElements

22

Riskassessmentsarereportedtohavethegreatestimpactontherefinementofreviewofperformancedata,changestothemonitoringplanandtraining–thesewerethetopthreemostfrequentlycitedrefinementsamongSponsorsandProvidersalike.

RiskAssessment

N:SPONSOR=174-207;PROVIDER=63-81Q:Howoftendoesyourriskassessmentprocessleadtotheintroductionorrefinementofeachofthefollowingproactivemeasuresdesignedtoreducerisk?

TypesofRefinementsMadeBasedonRiskAssessment

6%

4%

4%

4%

11%

7%

8%

13%

13%

11%

13%

16%

58%

60%

61%

62%

59%

66%

66%

64%

64%

68%

67%

70%

37%

35%

34%

34%

29%

28%

26%

23%

23%

20%

20%

14%

Reviewplanforperformancedata

Changestothemonitoringstrategy/plan/frequency

Trainingadditions/enhancements

Proceduraladditions/enhancements

Captureofperformancedata(notclinicaltrialdata)

Protocolamendments

DecisionsregardingCROs/othervendorsused

Changestothresholdsforcentralizeddatamonitoring

Personneladditions/enhancements

Changesinnumbersofsitesselected

Additionorremovalofspecificsites

Changesinlocationsofsitesselected

Never Between1%and50% 51%orMore%oftrials:

Sponsor

32%

36%

38%

26%

29%

23%

13%

19%

25%

17%

15%

15%

Provider51%orMore

2013:Reviewandcaptureofperformancedataweretoprefinements

23

ThereisadisconnectbetweenSponsors’reportedsatisfactionwithhowCROsaddressriskactivitiesrelativetohowProvidersseethemselvesasperforming.Similargapswereidentifiedin2013,suggestingthedynamichasshownlittlechangeovertime.*

RiskAssessment

N:SPONSOR=187-194;PROVIDER=104-112SPONSORQ:Ingeneral,howsatisfiedareyouwiththeperformanceofeachofyourin-houseteams,CROsandotherclinicalserviceprovidersyouworkwith,withrespecttoeachofthefollowing?PROVIDERQ.Ingeneral,howsatisfiedareyouwithyourcompany’steamswithrespecttoeachofthefollowing?

SatisfactionwithRiskActivities%veryorsomewhatsatisfied

Proactiveidentificationofpotentialrisks 46% 73%

Appropriatenessofmeasuressuggested/takeninreactiontoriskinfo 46% 70%

Overallperformanceonriskassessmentandmanagementactivities 43% 71%

Ownershipoverriskassessmentandmanagementrelatedactivities 43% 69%

Compilationofrisk-relatedtrialinformationduringatrial 41% 64%

Communicationsregardingrisk-relatedtrialinformation 41% 70%

Frequencyofreviewofrisk-relatedtrialinformation 39% 61%

Proactiveriskanalysisandevaluation 37% 65%

Rigorofreviewofrisk-relatedtrialinformation 36% 63%

SPONSOR PROVIDERAssessmentofCROs Self-Assessment

*The2013AvocaIndustryReportcanbefoundhere:http://theavocagroup.com/wp-content/uploads/2016/01/The_2013_Avoca_Report.pdf

24

36%

17%

22%

4%

6%

2%

Quality

Timeliness/Adherenceto

Timelines

ResourceEfficiency

VeryImpactful ExtremelyImpactful

27%

25%

18%

15%

12%

11%

3.2 (-.2) 3.4

2.9 (-.3) 3.2

2.8 (-.2) 3.0

Moderatemeanratingswereobservedintermsoftheperceivedimpactofriskassessmentandmanagementapproachesonquality,timelinessandresourceefficiency.Providersweresomewhatmorefavorableintheirresponse.

RiskAssessment

N:SPONSOR=219-227;PROVIDER=97-103Q:Howimpactfulhaveyourriskassessmentandmanagementapproachesbeenintermsofincreasing…?

SPONSOR PROVIDER

Quality

Timeliness/AdherencetoTimelines

ResourceEfficiency

MeanRatings:1=NotAtAllImpactful;5=ExtremelyImpactful

ImpactofRiskAssessmentonIncreasing…

25

Risk-BasedApproachesUtilizationandChallengesofRisk-BasedApproaches

26

Approximatelytwo-thirdsofSponsorsandProvidersreportfamiliaritywithbestpracticesinrisk-basedprovideroversightandinspectionpreparedness.Withrespecttorisk-basedqualitymanagementandsitemonitoring,Providersaremorelikelytoexpresshavinga“good”or“verygood”understanding.

Risk-BasedApproaches

FamiliaritywithRisk-BasedApproaches%havinga“good”or“verystrong”understandingofbestpractices

N:SPONSOR=270-272;PROVIDER=117-118Q:Howwouldyourateyourunderstandingofbestpracticesin…?

QualityManagement

Sponsor Provider

89%

ProviderOversight

Sponsor Provider

66%

SiteMonitoring

Sponsor

67%

Provider

InspectionPreparedness

Sponsor Provider

81%

64%64%

69%

72%

27

Byfunction,notabledifferencesareobservedwithrespecttotheleveloffamiliaritywithbestpracticesinrisk-basedqualitymanagementandinspectionpreparedness– thoseworkinginqualityexpressahigherlevelofknowledgethandothoseinclinicaloperations.


90%

69% 72%83%

64% 69%60% 58%

DefineQualityManagementApproaches

MonitorInvestigativeSites

DetermineLeveland/orTypeof

ProviderOversight

PrepareforInspections

N:SPONSOR:Quality=59-60,ClinicalOperations=153-154Q:Howwouldyourateyourunderstandingofbestpracticesin…?

QualityManagement

SiteMonitoring

ProviderOversight


FamiliaritywithRisk-BasedApproachesbySponsorRole%havinga“good”or“verystrong”understandingofbestpractices

SponsorsWorkinginQuality

SponsorsWorkinginClinicalOperations

28

52% 51% 51% 55%57% 57%

43%

60%

DefineQualityManagementApproaches

MonitorInvestigativeSites

DetermineLeveland/orTypeof

ProviderOversight

PrepareforInspections

Despitenotabledifferencesinreportedbehaviorandperceptionsregardingrisk,SponsorsandProvidersarewellalignedregardingtheutilizationofrisk-basedapproachestovariousaspectsoftrialmanagement– approximatelyhalfareusingthesemethodsin50%ormoreoftheirtrialstoday.


Sponsor Provider

UseofRisk-BasedApproachesto…%usinginmorethanhalfoftrials

QualityManagement

SiteMonitoring

ProviderOversight


N:SPONSOR=224-230;PROVIDER=72-83SPONSORQ:Howoftendoyourteamsusearisk-basedapproachto…?SPONSORQ:Howoftendoyouusearisk-basedapproachtodeterminetheleveland/ortypeofSponsoroversightemployedforFSPprovidersyouworkwith,withrespecttothefollowingoutsourcedfunctions?SPONSORQ:Howoftendoyouusearisk-basedapproachtoprepareforinspectionsforclinicaltrialswithfunctionsoutsourcedtoFSPs?PROVIDERQ:Howoftendoesyourcompanyusearisk-basedapproachto…?

29

SponsorsandProvidersalikereportthataligningpeopleandorganizationalthinking,aswellasthestructure,systemsandprocessesinplacetoassessandmanageriskarethemostsignificantchallengesthatarefacedintheuseofrisk-basedapproaches.


ChallengesRegardingUseofRisk-BasedApproaches

Q:Consideringyourcompany’suseofrisk-basedapproachestoclinicaltrialconduct,whataspectofthesehasbeenthemostchallenging?

AligningPeople&Thinking

“Mindshift-understandingthatimplementingQRMandRBMisnotaboutsavingmoney.Teamsstillreportissues,notrisksandtherisksidentifiedaremainlyfocusingontimelineandbudget,notonquality.”

“Adaptationofsuchanapproachandthebuy-infromallfunctionalparties.Theydon'tunderstanditwellenoughtoadoptandallowtheneededresourcestobeappliedinordertogetitofftheground.”

AligningSystems&Processes

“We'vehadchallengesinbringingtogether

disparatedatasourcesintooneRBMview

point.We'vealsobeenapplyingRBM

approachestolegacystudieswherethe

studysetuphasnotbeenconducivetodata

integration.”

30

40%45% 46% 44%

74% 79%

62% 66%

SponsorAssessmentofCROs/FSPs ProviderSelf-Assessment

Thereislackofalignmentonsatisfactionlevelsassociatedwithvariousriskactivities– whileamajorityofProvidersaresatisfiedwithwhattheirorganizationsareprovidingintheserespects,lessthanhalfofSponsorssaythesame.


N:SPONSOR=169-189;PROVIDER=71-86SPONSORQ:Overall,howsatisfiedhaveyoubeenwiththeCROs/FSPsyouworkwithintermsoftheir…?PROVIDERQ:Overall,howsatisfiedhaveyoubeenwithyourcompanyintermsofthe…?

SatisfactionwithRiskActivities%veryorsomewhatsatisfied

QualityManagement

SiteMonitoring

ProviderOversight


31

Sponsor Provider

Acrossallrisk-basedapproaches,only50%orlessfeelthatthemeasurestakenarehavingasignificantimpactonquality,timelinessandresourceefficiency.


N:SPONSOR=125-165;PROVIDER=38-71Q:Howimpactfulhavethefollowingrisk-basedapproachesbeenintermsofincreasing…?*RepresentsSponsorsratingoversightofCROs/FSPs(dependingonoutsourcingmodel)andProvidersratingoversightofotherclinicalserviceproviders.

46%

19% 16%

48%

24% 22%

Quality Timeliness ResourceEfficiency

QualityManagement

ProviderOversight*

SiteMonitoring


ImpactofRisk-BasedApproachesonIncreasing…%“extremely”or“veryimpactful”

36%28%

35%44%26% 31%


29%23% 18%

47% 38%29%


34% 28%20%

50%

30% 33%


32

KeyTake-Aways

33

KeyTake-Aways

• Despitemarkedshiftsinthelandscapeandinregulatoryrequirements,thesedatasuggestthatlittlehaschangedwithrespecttohowtheIndustryisapproachingandmanagingriskassessment.

• Thealignmentofpeopleandprocessesappearstobeasignificantbarrier inmorewidespreadadoptionofrisk-basedtechniquestoclinicaltrialmanagement.

• LargegapscontinuetoexistbetweenhowSponsorsperceivetheirenvironment,andspecificallytheirrelationshipswithProviders,andhowProvidersperceivetheirownperformance.

AvocaIntegratedConsultingandResearchdeliversafreshperspective— aclear,andneutraltakeonhowtoincreaseefficiency,improvequality,andmitigateriskinclinicaltrialexecutionandmanagement.

Avocapairsbest-in-classresearchcapabilitieswithateamthatunderstandswhattrendsmeanfortheindustryandhowtheyaffectyourday-to-daybusiness.

35

AvocaClientListPharmaceutical/Biotech ServiceProviders

TheAvocaQualityConsortiumbringstogetherquality,outsourcingandoperationalprofessionalsfrommemberpharma,biotech,nicheclinicalserviceproviders,andCROorganizationstoaccelerateandstreamlineclinicaltrialexecutionandimprovequalitythroughindustrycollaboration.

37

2017AQCMembers

Longboat

38

AppendixDemographics

39

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

40

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

41

Thankyou

ContactAvocaat:(609)252-9020

[email protected]

179NassauStreet,Suite3APrinceton,NJ08542

Documents

The 2017 Avoca Industry Reporttheavocagroup.com/wp-content/uploads/2017/09/2017... · 8 $52.5B $56.4B $60.7B 59% 65% 59% 66% 69% 61% 2015 2016 2017 R&D Spend (in billions)* Current