Soumettre la recherche
Mettre en ligne
A Peek at GCT 2012
•
1 j'aime
•
925 vues
C
ConferenceForum
Suivre
3rd Annual Executing Global Clinical Trials, Sept 2012, Mitchell Katz, Purdue Pharma L.P.
Lire moins
Lire la suite
Business
Signaler
Partager
Signaler
Partager
1 sur 40
Télécharger maintenant
Télécharger pour lire hors ligne
Recommandé
Dismantling Barriers to Adaptive Design Adoption to Be Key Theme of Pre-Disru...
Dismantling Barriers to Adaptive Design Adoption to Be Key Theme of Pre-Disru...
ConferenceForum
Steve Hoffmann
Steve Hoffmann
ConferenceForum
A Peek at CMO East 2013
A Peek at CMO East 2013
ConferenceForum
A Peek at Dpharm 2012
A Peek at Dpharm 2012
ConferenceForum
A Peek at CMO East 2013
A Peek at CMO East 2013
ConferenceForum
A Peek at GCT 2012 - Eileen Daniels
A Peek at GCT 2012 - Eileen Daniels
ConferenceForum
A Peek at Dpharm 2012
A Peek at Dpharm 2012
ConferenceForum
Statistical Thinking and Pharmaceutical Professional Development, a keynote b...
Statistical Thinking and Pharmaceutical Professional Development, a keynote b...
Ajaz Hussain
Recommandé
Dismantling Barriers to Adaptive Design Adoption to Be Key Theme of Pre-Disru...
Dismantling Barriers to Adaptive Design Adoption to Be Key Theme of Pre-Disru...
ConferenceForum
Steve Hoffmann
Steve Hoffmann
ConferenceForum
A Peek at CMO East 2013
A Peek at CMO East 2013
ConferenceForum
A Peek at Dpharm 2012
A Peek at Dpharm 2012
ConferenceForum
A Peek at CMO East 2013
A Peek at CMO East 2013
ConferenceForum
A Peek at GCT 2012 - Eileen Daniels
A Peek at GCT 2012 - Eileen Daniels
ConferenceForum
A Peek at Dpharm 2012
A Peek at Dpharm 2012
ConferenceForum
Statistical Thinking and Pharmaceutical Professional Development, a keynote b...
Statistical Thinking and Pharmaceutical Professional Development, a keynote b...
Ajaz Hussain
Online Resources to Support Open Drug Discovery Systems
Online Resources to Support Open Drug Discovery Systems
US Environmental Protection Agency (EPA), Center for Computational Toxicology and Exposure
2. This exercise uses the dataset WholeFoods.” (a) Use Excel to.docx
2. This exercise uses the dataset WholeFoods.” (a) Use Excel to.docx
eugeniadean34240
Data Mining and Big Data Analytics in Pharma
Data Mining and Big Data Analytics in Pharma
Ankur Khanna
A Review Of The Research Literature On Evidence-Based Healthcare Design
A Review Of The Research Literature On Evidence-Based Healthcare Design
Richard Hogue
Bioinformatics Strategies for Exposome 100416
Bioinformatics Strategies for Exposome 100416
Chirag Patel
Collaborative Drug Discovery: A Platform For Transforming Neglected Disease R...
Collaborative Drug Discovery: A Platform For Transforming Neglected Disease R...
Sean Ekins
Translational pharmacology new approach of drug discovery
Translational pharmacology new approach of drug discovery
pharmaindexing
There’s No Escape from External Validity – Reporting Habits of Randomized Con...
There’s No Escape from External Validity – Reporting Habits of Randomized Con...
Stockholm Institute of Transition Economics
Knowledge Translation in Child Welfare: Researcher-on-call tool
Knowledge Translation in Child Welfare: Researcher-on-call tool
Christine Wekerle
Searching for Relevant Studies
Searching for Relevant Studies
Effective Health Care Program
Running head HEALTH PROMOTION IN MINORITY POPULATIONS .docx
Running head HEALTH PROMOTION IN MINORITY POPULATIONS .docx
healdkathaleen
New Product Planning and Medical Affairs
New Product Planning and Medical Affairs
Anthony Russell
Implicate order Probabilistic Semantics
Implicate order Probabilistic Semantics
Srinidhi Boray
The Drug Development Process Kerentech
The Drug Development Process Kerentech
EstherMM
When pharmaceutical companies publish large datasets an abundance of riches o...
When pharmaceutical companies publish large datasets an abundance of riches o...
US Environmental Protection Agency (EPA), Center for Computational Toxicology and Exposure
A Value Proposition for Creating Crowdfunding Research Platform for Integrati...
A Value Proposition for Creating Crowdfunding Research Platform for Integrati...
Joanne Sienko Ott, CFA, MA
apcp Deeksha Bhartiya
apcp Deeksha Bhartiya
Ravi Mehrotra MD,PhD, FRCPath, FAMS
Roddy Analysis WorksheetUsing the worksheet below, complete an.docx
Roddy Analysis WorksheetUsing the worksheet below, complete an.docx
SUBHI7
Literature Review on Health & Safety
Literature Review on Health & Safety
HR at VASHI ELECTRICALS PVT. LTD.
Knowledge Discovery And Data Mining Of Free Text Final
Knowledge Discovery And Data Mining Of Free Text Final
kdjamies
Strategies for Developing & Commercializing Biobetters & Biosimilars
Strategies for Developing & Commercializing Biobetters & Biosimilars
ConferenceForum
Scott Harris
Scott Harris
ConferenceForum
Contenu connexe
Similaire à A Peek at GCT 2012
Online Resources to Support Open Drug Discovery Systems
Online Resources to Support Open Drug Discovery Systems
US Environmental Protection Agency (EPA), Center for Computational Toxicology and Exposure
2. This exercise uses the dataset WholeFoods.” (a) Use Excel to.docx
2. This exercise uses the dataset WholeFoods.” (a) Use Excel to.docx
eugeniadean34240
Data Mining and Big Data Analytics in Pharma
Data Mining and Big Data Analytics in Pharma
Ankur Khanna
A Review Of The Research Literature On Evidence-Based Healthcare Design
A Review Of The Research Literature On Evidence-Based Healthcare Design
Richard Hogue
Bioinformatics Strategies for Exposome 100416
Bioinformatics Strategies for Exposome 100416
Chirag Patel
Collaborative Drug Discovery: A Platform For Transforming Neglected Disease R...
Collaborative Drug Discovery: A Platform For Transforming Neglected Disease R...
Sean Ekins
Translational pharmacology new approach of drug discovery
Translational pharmacology new approach of drug discovery
pharmaindexing
There’s No Escape from External Validity – Reporting Habits of Randomized Con...
There’s No Escape from External Validity – Reporting Habits of Randomized Con...
Stockholm Institute of Transition Economics
Knowledge Translation in Child Welfare: Researcher-on-call tool
Knowledge Translation in Child Welfare: Researcher-on-call tool
Christine Wekerle
Searching for Relevant Studies
Searching for Relevant Studies
Effective Health Care Program
Running head HEALTH PROMOTION IN MINORITY POPULATIONS .docx
Running head HEALTH PROMOTION IN MINORITY POPULATIONS .docx
healdkathaleen
New Product Planning and Medical Affairs
New Product Planning and Medical Affairs
Anthony Russell
Implicate order Probabilistic Semantics
Implicate order Probabilistic Semantics
Srinidhi Boray
The Drug Development Process Kerentech
The Drug Development Process Kerentech
EstherMM
When pharmaceutical companies publish large datasets an abundance of riches o...
When pharmaceutical companies publish large datasets an abundance of riches o...
US Environmental Protection Agency (EPA), Center for Computational Toxicology and Exposure
A Value Proposition for Creating Crowdfunding Research Platform for Integrati...
A Value Proposition for Creating Crowdfunding Research Platform for Integrati...
Joanne Sienko Ott, CFA, MA
apcp Deeksha Bhartiya
apcp Deeksha Bhartiya
Ravi Mehrotra MD,PhD, FRCPath, FAMS
Roddy Analysis WorksheetUsing the worksheet below, complete an.docx
Roddy Analysis WorksheetUsing the worksheet below, complete an.docx
SUBHI7
Literature Review on Health & Safety
Literature Review on Health & Safety
HR at VASHI ELECTRICALS PVT. LTD.
Knowledge Discovery And Data Mining Of Free Text Final
Knowledge Discovery And Data Mining Of Free Text Final
kdjamies
Similaire à A Peek at GCT 2012
(20)
Online Resources to Support Open Drug Discovery Systems
Online Resources to Support Open Drug Discovery Systems
2. This exercise uses the dataset WholeFoods.” (a) Use Excel to.docx
2. This exercise uses the dataset WholeFoods.” (a) Use Excel to.docx
Data Mining and Big Data Analytics in Pharma
Data Mining and Big Data Analytics in Pharma
A Review Of The Research Literature On Evidence-Based Healthcare Design
A Review Of The Research Literature On Evidence-Based Healthcare Design
Bioinformatics Strategies for Exposome 100416
Bioinformatics Strategies for Exposome 100416
Collaborative Drug Discovery: A Platform For Transforming Neglected Disease R...
Collaborative Drug Discovery: A Platform For Transforming Neglected Disease R...
Translational pharmacology new approach of drug discovery
Translational pharmacology new approach of drug discovery
There’s No Escape from External Validity – Reporting Habits of Randomized Con...
There’s No Escape from External Validity – Reporting Habits of Randomized Con...
Knowledge Translation in Child Welfare: Researcher-on-call tool
Knowledge Translation in Child Welfare: Researcher-on-call tool
Searching for Relevant Studies
Searching for Relevant Studies
Running head HEALTH PROMOTION IN MINORITY POPULATIONS .docx
Running head HEALTH PROMOTION IN MINORITY POPULATIONS .docx
New Product Planning and Medical Affairs
New Product Planning and Medical Affairs
Implicate order Probabilistic Semantics
Implicate order Probabilistic Semantics
The Drug Development Process Kerentech
The Drug Development Process Kerentech
When pharmaceutical companies publish large datasets an abundance of riches o...
When pharmaceutical companies publish large datasets an abundance of riches o...
A Value Proposition for Creating Crowdfunding Research Platform for Integrati...
A Value Proposition for Creating Crowdfunding Research Platform for Integrati...
apcp Deeksha Bhartiya
apcp Deeksha Bhartiya
Roddy Analysis WorksheetUsing the worksheet below, complete an.docx
Roddy Analysis WorksheetUsing the worksheet below, complete an.docx
Literature Review on Health & Safety
Literature Review on Health & Safety
Knowledge Discovery And Data Mining Of Free Text Final
Knowledge Discovery And Data Mining Of Free Text Final
Plus de ConferenceForum
Strategies for Developing & Commercializing Biobetters & Biosimilars
Strategies for Developing & Commercializing Biobetters & Biosimilars
ConferenceForum
Scott Harris
Scott Harris
ConferenceForum
Thomas Krohn - Dpharm 2012 - Disruptive Innovation: Moving Beyond the Talk
Thomas Krohn - Dpharm 2012 - Disruptive Innovation: Moving Beyond the Talk
ConferenceForum
GCT 2012 Helmut Wolf Keynote on Emerging Markets
GCT 2012 Helmut Wolf Keynote on Emerging Markets
ConferenceForum
Dpharm 2012: Using Innovative Partnerships to Drive Measurable Progress in Gl...
Dpharm 2012: Using Innovative Partnerships to Drive Measurable Progress in Gl...
ConferenceForum
Changing Paradigms in Outsourcing, Liz Stoner
Changing Paradigms in Outsourcing, Liz Stoner
ConferenceForum
Kent Rogers, Acorda, New Paradigms 2012
Kent Rogers, Acorda, New Paradigms 2012
ConferenceForum
Ian sanderson
Ian sanderson
ConferenceForum
Ian sanderson
Ian sanderson
ConferenceForum
Ian sanderson
Ian sanderson
ConferenceForum
Podd slides 1
Podd slides 1
ConferenceForum
Podd slides
Podd slides
ConferenceForum
Podd slide deck mark kontny
Podd slide deck mark kontny
ConferenceForum
Podd c no.1366 salles final oct 2011-1
Podd c no.1366 salles final oct 2011-1
ConferenceForum
Matt Whalen & Linda Strause GCT 2012
Matt Whalen & Linda Strause GCT 2012
ConferenceForum
Sohini Chowdhury, 2011
Sohini Chowdhury, 2011
ConferenceForum
Plus de ConferenceForum
(16)
Strategies for Developing & Commercializing Biobetters & Biosimilars
Strategies for Developing & Commercializing Biobetters & Biosimilars
Scott Harris
Scott Harris
Thomas Krohn - Dpharm 2012 - Disruptive Innovation: Moving Beyond the Talk
Thomas Krohn - Dpharm 2012 - Disruptive Innovation: Moving Beyond the Talk
GCT 2012 Helmut Wolf Keynote on Emerging Markets
GCT 2012 Helmut Wolf Keynote on Emerging Markets
Dpharm 2012: Using Innovative Partnerships to Drive Measurable Progress in Gl...
Dpharm 2012: Using Innovative Partnerships to Drive Measurable Progress in Gl...
Changing Paradigms in Outsourcing, Liz Stoner
Changing Paradigms in Outsourcing, Liz Stoner
Kent Rogers, Acorda, New Paradigms 2012
Kent Rogers, Acorda, New Paradigms 2012
Ian sanderson
Ian sanderson
Ian sanderson
Ian sanderson
Ian sanderson
Ian sanderson
Podd slides 1
Podd slides 1
Podd slides
Podd slides
Podd slide deck mark kontny
Podd slide deck mark kontny
Podd c no.1366 salles final oct 2011-1
Podd c no.1366 salles final oct 2011-1
Matt Whalen & Linda Strause GCT 2012
Matt Whalen & Linda Strause GCT 2012
Sohini Chowdhury, 2011
Sohini Chowdhury, 2011
Dernier
How to Get Started in Social Media for Art League City
How to Get Started in Social Media for Art League City
Eric T. Tung
Arti Languages Pre Seed Teaser Deck 2024.pdf
Arti Languages Pre Seed Teaser Deck 2024.pdf
will854175
Durg CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN durg ESCORTS
Durg CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN durg ESCORTS
kajalroy875762
Paradip CALL GIRL❤7091819311❤CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Paradip CALL GIRL❤7091819311❤CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
pr788182
PHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation Final
PanhandleOilandGas
Getting Real with AI - Columbus DAW - May 2024 - Nick Woo from AlignAI
Getting Real with AI - Columbus DAW - May 2024 - Nick Woo from AlignAI
Tim Wilson
Unveiling Falcon Invoice Discounting: Leading the Way as India's Premier Bill...
Unveiling Falcon Invoice Discounting: Leading the Way as India's Premier Bill...
Falcon Invoice Discounting
Phases of Negotiation .pptx
Phases of Negotiation .pptx
nandhinijagan9867
Call 7737669865 Vadodara Call Girls Service at your Door Step Available All Time
Call 7737669865 Vadodara Call Girls Service at your Door Step Available All Time
gargpaaro
New 2024 Cannabis Edibles Investor Pitch Deck Template
New 2024 Cannabis Edibles Investor Pitch Deck Template
CannaBusinessPlans
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
pr788182
Nashik Call Girl Just Call 7091819311 Top Class Call Girl Service Available
Nashik Call Girl Just Call 7091819311 Top Class Call Girl Service Available
pr788182
Challenges and Opportunities: A Qualitative Study on Tax Compliance in Pakistan
Challenges and Opportunities: A Qualitative Study on Tax Compliance in Pakistan
vineshkumarsajnani12
Cannabis Legalization World Map: 2024 Updated
Cannabis Legalization World Map: 2024 Updated
CannaBusinessPlans
Falcon Invoice Discounting: Empowering Your Business Growth
Falcon Invoice Discounting: Empowering Your Business Growth
Falcon investment
PARK STREET 💋 Call Girl 9827461493 Call Girls in Escort service book now
PARK STREET 💋 Call Girl 9827461493 Call Girls in Escort service book now
kapoorjyoti4444
Marel Q1 2024 Investor Presentation from May 8, 2024
Marel Q1 2024 Investor Presentation from May 8, 2024
Marel
Berhampur Call Girl Just Call 8084732287 Top Class Call Girl Service Available
Berhampur Call Girl Just Call 8084732287 Top Class Call Girl Service Available
pr788182
Putting the SPARK into Virtual Training.pptx
Putting the SPARK into Virtual Training.pptx
Cynthia Clay
Buy gmail accounts.pdf buy Old Gmail Accounts
Buy gmail accounts.pdf buy Old Gmail Accounts
Buy Verified Cash App Account
Dernier
(20)
How to Get Started in Social Media for Art League City
How to Get Started in Social Media for Art League City
Arti Languages Pre Seed Teaser Deck 2024.pdf
Arti Languages Pre Seed Teaser Deck 2024.pdf
Durg CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN durg ESCORTS
Durg CALL GIRL ❤ 82729*64427❤ CALL GIRLS IN durg ESCORTS
Paradip CALL GIRL❤7091819311❤CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Paradip CALL GIRL❤7091819311❤CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
PHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation Final
Getting Real with AI - Columbus DAW - May 2024 - Nick Woo from AlignAI
Getting Real with AI - Columbus DAW - May 2024 - Nick Woo from AlignAI
Unveiling Falcon Invoice Discounting: Leading the Way as India's Premier Bill...
Unveiling Falcon Invoice Discounting: Leading the Way as India's Premier Bill...
Phases of Negotiation .pptx
Phases of Negotiation .pptx
Call 7737669865 Vadodara Call Girls Service at your Door Step Available All Time
Call 7737669865 Vadodara Call Girls Service at your Door Step Available All Time
New 2024 Cannabis Edibles Investor Pitch Deck Template
New 2024 Cannabis Edibles Investor Pitch Deck Template
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Berhampur 70918*19311 CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Nashik Call Girl Just Call 7091819311 Top Class Call Girl Service Available
Nashik Call Girl Just Call 7091819311 Top Class Call Girl Service Available
Challenges and Opportunities: A Qualitative Study on Tax Compliance in Pakistan
Challenges and Opportunities: A Qualitative Study on Tax Compliance in Pakistan
Cannabis Legalization World Map: 2024 Updated
Cannabis Legalization World Map: 2024 Updated
Falcon Invoice Discounting: Empowering Your Business Growth
Falcon Invoice Discounting: Empowering Your Business Growth
PARK STREET 💋 Call Girl 9827461493 Call Girls in Escort service book now
PARK STREET 💋 Call Girl 9827461493 Call Girls in Escort service book now
Marel Q1 2024 Investor Presentation from May 8, 2024
Marel Q1 2024 Investor Presentation from May 8, 2024
Berhampur Call Girl Just Call 8084732287 Top Class Call Girl Service Available
Berhampur Call Girl Just Call 8084732287 Top Class Call Girl Service Available
Putting the SPARK into Virtual Training.pptx
Putting the SPARK into Virtual Training.pptx
Buy gmail accounts.pdf buy Old Gmail Accounts
Buy gmail accounts.pdf buy Old Gmail Accounts
A Peek at GCT 2012
1.
3rd$Annual$Execu.ve$Global$ Clinical$Trials$ Mitchell(Katz,(Ph.D.( Execu3ve(Director,(Medical(Research(Opera3ons( Purdue(Pharma(L.P.( September(2012(
2.
2( Pharma’s$Largest$Layoffs$in$2012$
3.
3( CRO$Consolida.on$ ! INC( " Kendle( !
Theorem( " Omnicare( " IBAH( ! Pharmanet/i3( " Inven3ve(Health( ! Private(Equity( " PPD( " RPS( " PRA(
4.
4( Outsourcing$Buzz$Words$ ! Partnerships( ! Alliances( !
Preferred(Models( ! Hybrid(Models( ! Func3onal(Models( ! Transac3onal(Models( ! Offshoring( ! “Strategic(Rela3onships”(
5.
5( Johnson$&$Johnson$and$ICON$ #1(–(Failure(to(ensure(proper(monitoring(of(the(clinical( inves3ga3ons([21(CFR(312.50(and(312.56(a)( #2(–(Failure(to(ensure(that(an(inves3ga3on(was(conducted(in( accordance(with(the(general(inves.ga.onal$plan$and( protocols(as(specified(in(the(IND([21(CFR(312.50]( #3(–(Failure(to(secure(inves.gator$compliance$with(the( inves3ga3onal(plan(and(applicable(FDA(regula3ons([21(CFR( 312.56(b)]( #4(–(Failure(to(ensure(that(only(inves3gators(who(were( qualified(by(training(and(experience(were(selected(as( appropriate(experts(to(inves3gate(a(drug([21(CFR(212.53(a)](
6.
6(
7.
7( It’s$All$About$.$.$.$ ( ( QUALITY$
8.
8( Avoca$Quality$Consor.um$ ( Pharma(and(Biotech(members((to(date):( ! Alexion(Pharmaceu3cals,(Amgen,(Astellas(Pharma,(AstraZeneca,(Biogen( Idec,(BristoldMyers(Squibb,(Cerexa,(Cubist(Pharmaceu3cals,(Daiichi( Sankyo,(Eli(Lilly(and(Company,(GlaxoSmithKline,(Grünenthal,(ImClone( Systems,(Janssen(Research(&(Development,(Otsuka,(Pfizer,(Purdue,(and( Roche( CRO(members((to(date):( ! Chiltern(Interna3onal,(Covance,(INC(Research,(ICON,(Harrison(Clinical( Research,(PAREXEL(Interna3onal,(PharmaNet/i3,(PRA(Interna3onal,( Quin3les,(Theorem(Clinical(Research,(and(RPS( ( Corporate(Sponsors:(
9.
Quality$Management$and$CRO$ Oversight$
10.
10( Agenda$ ! Overview:(Background(and(context( ! Part$1:(Overall(percep3ons(and(the( “disconnects”(between(sponsors(and(CROs( around(issues(of(quality( !
Part$2:(Root(causes(of(quality(issues(and(the( issue(of(“micromanagement”( ! Part$3:(Best(prac3ce(approaches(associated( with(sa3sfac3on( ! Open(discussion(
11.
11( Context$for$Research$on$Quality$and$ CRO$Oversight$ ! Increase(in(clinical(outsourcing( ! Consolida3on(of(spend(with(few(clinical(service(providers( !
Globaliza3on(of(clinical(trials:(increase(in(number(of(studies(in(lessdexperienced(developing( regions( ! Focus(on(efficiencies(and(cost(savings( ! Increase(in(the(number(of(highdprofile(FDA(warning(lemers( Focus(on(Avoca’s(2011(Industry(Survey:(percep3ons(from(sponsors(and(CROs(on(the(quality(of( outsourced(trials( Focus(of(Avoca’s(Quality(Consor3um:(proac3ve(quality(management( The$focus$and$vision$of$the$Quality$Consor5um$are$to$accelerate$the$development$of$an$industry$ standard$and$best9prac5ce$approach$to$the$quality$management$of$outsourced$trials$through$the$ sharing$of$best$prac5ces$
12.
12( Methods$ ! Surveys(explored(respondents’(views(and(experiences(regarding:( " Sa3sfac3on(with(quality(of(work(delivered(by(clinical(service(providers( "
Approaches(to(managing(quality(in(outsourced(clinical(trials,(including( quality(metrics,(repor3ng(tools,(and(desktop(analy3cs( " Scope(and(u3lity(of(Quality(Agreements( " Other(tools(used(to(set(expecta3ons(for(quality(in(outsourced(clinical( trials( " Quality(concerns(and(management(when(outsourcing(in(Emerging( Markets( " Quality(considera3ons(in(selec3ng(CROs(
13.
13( 2011$Industry$Survey$ ! 104(sponsor(surveys(from(66( companies( " 73%(pharma,( 17%(biotech( "
52%(“Top(20”( " 44%(Opera3ons,( 40%(Outsourcing( " 17%(execu3ves,( 58%(middle(management(( ! 143(provider(surveys(from(88( companies( " 78%(CROs( " 64%(“Top(20”( " 38%(Opera3ons,( 31%(BD,( 22%(Management( " 48%(execu3ves,( 39%(middle(management(( 247(Surveys(
14.
14( Quality$Consor.um$Assessment$ ! 428(sponsor(surveys(were(deployed(resul3ng(in(feedback(from(334( individuals( " Overall(response(rate:(78%( "
Completed(surveys/company:(10d46((note(that(there(was(no(associa3on( between(company(size(and(number(of(respondents)( " Range(of(response(rates/company:(50%d100%( ! 298(CRO(surveys(were(deployed(resul3ng(in(feedback(from(207(individuals( " Overall(response(rate:(69%( " Completed(surveys/company:(4d59((note(that(there(was(no(associa3on( between(company(size(and(number(of(respondents)( " Range(of(response(rates/company:(27%d100%(
15.
Part$1:$$Framing$the$Quality$Issue$ Overall(percep3ons(and(the( “disconnects”(between(sponsors(and( CROs(around(issues(of(quality(
16.
16( Methods$ ! “Quality”(was(defined(as(“The$ability$to$effec.vely$and$efficiently$answer$ the$intended$ques.on$about$the$benefits$and$risks$of$a$medical$product$ or$procedure$while$assuring$pa.ent$safety$and$protec.on$of$human$ subjects”$ ! As(examples,(elements(of(a(quality(clinical(study(were(said(to(include,(but( not(limited(to:( "
Scien3fically(valid(and(ethically(sound(experimental(design( " Adequate(protec3on(of(subjects’(rights,(safety(and(welfare( " Qualified(personnel( " Adequate(monitoring( " Current,(complete,(and(accurate(data( " Accurate(presenta3on(and(interpreta3on(of(data(
17.
17( Industry$Survey$Sponsors:$Overall$ Sa.sfac.on$
18.
18( Consor.um$Sponsors:$Sa.sfac.on$ with$Quality$
19.
19( Consor.um$Sponsors:$Comparison$of$ CRO$Quality$to$Sponsor$Internal$ Teams$
20.
20( Sa.sfac.on$with$Quality$
21.
21( Industry$Survey:$Provider$Sa.sfac.on$
22.
22( Sponsors:$Sa.sfac.on$with$Quality$ Areas(with(rela3vely(high(sa3sfac3on(included:( ! Compliance(with(SOPs(and(other(wrimen(procedures( ! Data$quality$and$integrity$ !
Audit(plans(and(execu3on( Areas(with(rela3vely(high(dissa3sfac3on(included:( ! Oversight(of(third(party(vendors( ! Governance(of(quality( ! Communica3ons(surrounding(quality( ! Availability(of(quality(personnel(for(projects( ! Efficiency/.meliness$in$achieving$clean$data$ ! Adherence(to(monitoring(plan(
23.
Part$2:$$Causes$of$Quality$Issues$
24.
24( Causes$of$Issues$with$Quality$ “CROs,$as$service$providers,$are$heavily$incented$to$ deliver$and$measure$quality$–$and$are$prepared$to$do$ so.$$Too$many$sponsors$are$not$prepared$to$do$their$ part$in$assuring$a$rela5onship$focused$on$quality.$$So$ CROs$are$forced$to$implement$one$model$for$sponsors$ ready$to$focus$on$quality,$and$another$for$the$many$ focused$on$ac5vi5es$and$unit9level$cost.”$ ( ( (d(Quota3on(from(an(Industry(Survey(Provider(Respondent( ( (
25.
25( Causes$of$Issues$with$Quality:$Sponsor$ Consor.um$Data$
26.
26( Industry$Survey:$Causes$of$Issues$with$ Quality$
27.
27( Quality$vs.$Costs$
28.
28( Causes$of$Issues$with$Quality$ #1:$Cost$Pressures$ “The$focus$on$price$has$driven$out$the$reality$of$adequate$ monitoring$and$proper$Quality$Control$processes$to$ensure$quality$ at$the$site$level…$Too$many$procurement$officers$are$making$ decisions$purely$on$cost$without$regards$to$quality$product.”$ “Price$pressures,$especially$discounts…have$caused$some$CROs$to$ cut$corners$and$send$work$to$low$cost$regions$without$adequately$ trained$staff.”$ “Price$reduc5ons$required$to$‘play$the$game’$in$the$preferred$ provider$selec5on$process$make$it$very$difficult$to$con5nue$to$ resource$adequately.$$Sponsors$say$they$will$streamline$processes$ going$forward$to$reduce$workload$but$hardly$ever$do.”$
29.
29( Causes$of$Issues$with$Quality$ #2:(Sponsors(DecisiondMaking(with( Impacts(on(Quality((without(provider( input)( ! Oversight((level(of(monitoring)( ! Protocol(design( !
Inves3gators(&(regions( ! Timelines( ! Processes( ! Thirddparty(vendors( “It$is$difficult$to$ensure$quality$for$a$func5onal$provider$for$monitoring,$when$ the$protocol$design/site$selec5on$are$done$by$another$CRO/sponsor.”$ “There$is$a$percentage$of$work$that$we$perform$that$is$working$with$the$ sponsor$processes,$etc…in$these$circumstances,$quality,$5meliness,$training,$ governance$and$oversight$are$dictated$by$sponsor$requirements.”$
30.
30( Causes$of$Issues$with$Quality$ #3:$Sponsor$Failure$to$Proac.vely$Make$Decisions$or$ Communicate$with$Providers$about$Quality$Expecta.ons$ Industry(survey(data:( ! Only(55%(of(sponsors(are(sa3sfied(with(their(companies’(iden3fica3on(of(process/ deliverables(for(which(quality(expecta3ons(of(CROs(need(to(be(set.( ! Only(58%(feel(that(their(companies(effec3vely(communicate(quality(expecta3ons( to(CROs( !
Strong(associa3on(between(“proac3ve”(management(of(quality(and(ability(to( forego(micromanagement.(
31.
Part$3:$$Results$ What(can(be(done(to(enhance(quality(while( reducing(micromanagement?( What$quality$prac.ces$are$associated$with$ enhanced$sa.sfac.on?$
32.
32( Industry$Survey$Sponsors:$Quality$ Metrics$
33.
33( Consor.um$Survey:$Quality$Metrics$
34.
34( Quality$Agreements$
35.
35( Industry$Survey$Sponsors:$Quality$ Agreements$
36.
36( Industry$Survey$Sponsors:$Quality$ Agreements$
37.
37( Other$Prac.ces$Impac.ng$Quality$ Risk$Based$Approaches$ ! 57%(of(sponsors(and(58%(of(CROs(use(a(formal,(riskdbased( approach(to(levels(of(site(monitoring((industry(survey(data)( " About(2/3(have(had(primarily(posi3ve(experiences(–(1/3(mixed( !
Most(sponsors((67%)(and(CROs((79%)(do(maintain( documenta3on(of(site(performance(on(previous(trials(to( factors(into(such(models.( " Performance(data(most(commonly(includes(number(of(protocol( viola3ons,(number(of(queries,(type(and(severity(of(protocol( viola3ons,(promptness(of(data(entry,(types(of(queries,(and(3me( to(resolu3on(of(queries.(
38.
38( Quality$by$Region$
39.
39( Summary$ ! While(developing(standards(and(more( efficient(ways(for(sponsors(and(CROs(to(work( together(is(necessary,(it(has(been( challenging.( ! There(is(greater(poten3al(for(success(in( terms(of(the(ability(to(quickly(move(towards( standards:( (
( (Quality(Agreements( ( ( (Quality(Metrics( ! There(is(no(onedsize(fits(all(CRO(model(
40.
Open$Discussion$ ( Thank(You(
Télécharger maintenant