How to Establish an Accountable Post-Acute Preferred Provider ...
Preferred provider use
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Expectations for data quality Global footprint* Low cost Metrics for meeting overall project timelines Operational excellence Prior positive experience with service provider Project manager quality Provider responsiveness Therapeutic expertise The most important attribute for sponsors to include a CRO on their preferred provider list across all research phases is Operational excellence. However, each attribute was indicated as a Top 5 driver for at least 20% of respondents in one or more phases. Preferred provider selection drivers *Phase I respondents indicating the importance of Location of Phase I units in different global locations were coded into the Global footprint table. Top 5 driver for of CRO respondents Top 5 driver for of CRO respondents Top 5 driver for of CRO respondents Top 5 driver for of CRO respondents Top 5 driver for of CRO respondents Top 5 driver for of CRO respondents Top 5 driver for of CRO respondents Top 5 driver for of CRO respondents Top 5 driver for of CRO respondents Phase I CRO Phase II/III CRO Phase IV CRO eTMF software Small molecule (SM) API CMO SM drug product CMO Biologic API CMO Biologic drug product CMO 11% 13% 16% 25% 28% 28% 22% 20% 16% 33% 31% 34% 30% 30% 25% 25% 23% 22% 5% 5% 7% 7% 11% 12% 12% 6% 8% 11% 13% 13% 15% 14% 16% 15% 31% 25% 23% 9% 6% 2% 3% 4% 11% 6% 10% 11% 8% 53% Phase I CRO Phase II/III CRO Phase IV CRO eTMF software SM API CMO SM drug product CMO Biologic API CMO Biologic drug product CMO Phase I CRO Phase II/III CRO Phase IV CRO eTMF software SM API CMO SM drug product CMO Biologic API CMO Biologic drug product CMO Phase I CRO Phase II/III CRO Phase IV CRO eTMF software SM API CMO SM drug product CMO Biologic API CMO Biologic drug product CMO Phase I CRO Phase II/III CRO Phase IV CRO eTMF software SM API CMO SM drug product CMO Biologic API CMO Biologic drug product CMO Phase I CRO Phase II/III CRO Phase IV CRO eTMF software SM API CMO SM drug product CMO Biologic API CMO Biologic drug product CMO 0% 55% 50% 45% 40% 35% 30% % of Respondents 25% 20% 15% 10% 5% Number of preferred providers Respondents indicated their companies tend to have more preferred providers for manufacturing work, and fewer for outsourced technologies. About half of sponsors that have preferred providers for technology only have one provider on their list. eTMF mean: 2.0 Number of preferred providers Phase IV mean: 3.2 Phase II/III mean: 3.6 Phase I mean: 3.7 Biologic API mean: 4.0 Biologic drug product mean: 4.3 SM drug product mean: 4.6 SM API mean: 4.7 N O N - LA R G E : 2 9 % L A R G E : 7 5 % OF SPONSORS OVERALL (n=296) Phase II/III CRO outsourcing Phase I CRO outsourcing N O N - L A R G E : 2 0 % L A R G E : 6 8 % OF SPONSORS OVERALL (n=240) Preferred provider use About half of sponsors use preferred providers for outsourced clinical, manufacturing, or software work. However, there are differences in usage rates between large and non-large sponsors; large sponsors are more likely to use preferred providers. N O N - L A R G E : 4 0 % L A R G E : 6 0 % OF SPONSORS OVERALL (n=187) Biologic drug product CMO outsourcing N O N - L A R G E : 4 2 % L A R G E : 5 5 % OF SPONSORS OVERALL (n=208) Biologic API CMO outsourcing N O N - L A R G E : 4 1 % L A R G E : 5 9 % OF SPONSORS OVERALL (n=242) SM drug product CMO outsourcing N O N - L A R G E : 4 4 % L A R G E : 6 2 % OF SPONSORS OVERALL (n=241) Small molecule (SM) API CMO outsourcing OF SPONSORS OVERALL (n=95) eTMF software outsourcing N O N - L A R G E : 1 7 % L A R G E : 5 3 % OF SPONSORS OVERALL (n=218) Phase IV CRO outsourcing Industry Standard Research takes a wide look at preferred provider arrangements with research, software, and manufacturing organizations by presenting data on preferred provider use, quantity, and selection drivers.
Transcript of Preferred provider use
Expectations for data quality
Global footprint*
Lowcost
Metrics for meeting overall project timelines
Operational excellence
Prior positive experience with service provider
Project managerquality
Providerresponsiveness
Therapeuticexpertise
The most important attribute for sponsors to include a CRO on their preferred provider list across all research phases is Operational excellence. However, each attribute was indicated as a Top 5 driver for at least 20% of respondents in one or more phases.
Preferredproviderselectiondrivers
*Phase I respondents indicating the importance of Location of Phase I units in different global locations were coded into the Global footprint table.
Top 5 driver for
of CRO respondents
Top 5 driver for
of CRO respondents
Top 5 driver for
of CRO respondents
Top 5 driver for
of CRO respondents
Top 5 driver for
of CRO respondents
Top 5 driver for
of CRO respondents
Top 5 driver for
of CRO respondents
Top 5 driver for
of CRO respondents
Top 5 driver for
of CRO respondents
Phase I CROPhase II/III CRO
Phase IV CROeTMF software
Small molecule (SM) API CMOSM drug product CMO
Biologic API CMOBiologic drug product CMO
11%13%
16%
25%28%
28%
22%
20%
16%
33%
31%
34%30%30%
25%
25%
23%22%
5%
5%
7%
7%
11%
12%
12%6%
8%
11%
13%13%
15%
14%16%
15%
31%25%
23%
9%6%
2%
3%4%
11%
6%10%
11%8%
53%
Phase I CRO Phase II/III CRO
Phase IV CROeTMF software
SM API CMOSM drug product CMO
Biologic API CMOBiologic drug product CMO
Phase I CROPhase II/III CRO
Phase IV CROeTMF software
SM API CMOSM drug product CMO
Biologic API CMOBiologic drug product CMO
Phase I CROPhase II/III CRO
Phase IV CROeTMF software
SM API CMOSM drug product CMO
Biologic API CMOBiologic drug product CMO
Phase I CROPhase II/III CRO
Phase IV CROeTMF software
SM API CMOSM drug product CMO
Biologic API CMOBiologic drug product CMO
Phase I CROPhase II/III CRO
Phase IV CROeTMF software
SM API CMOSM drug product CMO
Biologic API CMOBiologic drug product CMO
0% 55%50%45%40%35%30%% of Respondents
25%20%15%10%5%
Number ofpreferredproviders
Respondents indicated their companies tend to have more preferred providers for manufacturing work, and fewer for outsourced technologies. About half of sponsors that have preferred providers for technology only have one provider on their list.
eTMF mean: 2.0
Num
ber o
f pre
ferr
ed p
rovi
ders
Phase IV mean: 3.2Phase II/III mean: 3.6Phase I mean: 3.7
Biologic API mean: 4.0Biologic drug product mean: 4.3SM drug product mean: 4.6SM API mean: 4.7
NON-LARGE: 29%
LARGE: 75%
OF SPONSORSOVERALL (n=296)
Phase II/IIICRO outsourcing
Phase ICRO outsourcing
NON-LARGE: 20%
LARGE : 68%
OF SPONSORS OVERALL (n=240)
Preferredprovideruse
About half of sponsors use preferred providers for outsourced clinical, manufacturing, or software work. However, there are differences in usage rates between large and non-large sponsors; large sponsors are more likely to use preferred providers.
NON-LARGE: 40%
LARGE: 60%
OF SPONSORSOVERALL (n=187)
Biologic drug productCMO outsourcing
NON-LARGE: 42%
LARGE: 55%
OF SPONSORSOVERALL (n=208)
Biologic APICMO outsourcing
NON-LARGE: 41%
LARGE: 59%
OF SPONSORSOVERALL (n=242)
SM drug productCMO outsourcing
NON-LARGE: 44%
LARGE: 62%
OF SPONSORSOVERALL (n=241)
Small molecule (SM)API CMO outsourcing
OF SPONSORSOVERALL (n=95)
eTMF softwareoutsourcing
NON-LARGE: 17%
LARGE: 53%
OF SPONSORSOVERALL (n=218)
Phase IV CRO outsourcing
Industry Standard Research takes a wide look at preferred provider arrangements with research, software, and manufacturing organizations by presenting data on preferred provider use, quantity, and selection drivers.
