2010 CP Outsourcing Survey

8/8/2019 2010 CP Outsourcing Survey

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W E L CO M E T O O U R 6th Annual CONTRACT PHARMAOutsourcing Survey! More than 350 sponsor-side respon-dents offered up their opinions on outsourcing trends for this

years poll.

On the following pages, weve provided a sample of the find-

ings, focusing mainly on the major outsourcing projections of our

respondents, broken out by their business categories. Heres a

breakdown of the respondents:

Signs of Improvement?

Last year, a whopping 62% of total respondents believed that

theyd spend the same or less on outsourcing spending in

the coming year;this year,that dipped to 55%. Happily, the 10%+

less spending than previous year respondents dropped from

to 13%; from 23% last year, while no change increased from to

29% of all correspondents, from 25% last year.

Along those lines, 35% of respondents said that they had

cancelled outsourcing projects in the previous year due to

the economy; the same percentage as in our 2009 survey. We

added to reduce company size to our responses for Why

does your company outsource?; 7% of respondents chose

that answer, led by Top 20 Pharma, with 41% of those responses.

GYR

Photo courtesy of Fisher Clinical Services

CompanyType

Top 20 Pharma . . . . . . .23.4%

Small/Mid-Tier Pharma .18.0%

Generic Pharma . . . . . .10.1%

Virtual Pharma . . . . . . . .9.8%

Emerging Biopharma . . . .8.2%

Specialty Pharma . . . . . . .7.0%

Top 10 Biopharma . . . . . .6.3%

Consumer/ . . . . . . . . . . .3.5%

OTC Healthcare

Other . . . . . . . . . . . . . . .13.6%

Job Function

R&D . . . . . . . . . . . . . . . .21.5%

Corp. Mgmt. . . . . . . . . .13.0%

QA/QC/Validation . . . .12.3%

Project Manager . . . . . . .9.5%

Contract Manager . . . . . .6.6%

Purchasing/Sourcing . . . .5.7%

Production/Mfg./Pkg. . . . .5.7%

Business Development . .5.7%

Marketing/Sales . . . . . . . .5.4%

Clinical Research . . . . . . .4.1%

Supply Chain Manager . . .3.5%Regulatory Affairs . . . . . .2.5%

Engineering . . . . . . . . . . .1.3%

Other . . . . . . . . . . . . . . . .3.2%

ANNUAL

OUTSOURCING

SURVEY

ANNUAL

OUTSOURCING

SURVEY

The Science Of Research

At DiTEBA, we are committed to your success by providing

analytical and bioanalytical chemistry services that accelerate

R&D intensive projects.

As a pharmaceutical contract research organization, we strive

to be an innovative and cost-effective partner that delivers

consistent, quality services with unmatched integrity.

Through the science of research, let DiTEBA expedite

the process of bringing your product to market.

1620Tech Avenue, Unit 3

Mississauga, ON CanadaL4W5P4

18006719053

9056257995

9056253767

[email protected]

Toll Free:Phone:

Fax:

Analytical Testing

Bioanalytical Testing

Stability Storage and Testing

Cleaning Verification and

Validation Testing

Formulation DevelopmentSupport Testing

In Vitro Release Rate Testing

Physical Testing

ReaResearchTurning Research Into Re
http://www.diteba.com/mailto:[email protected]?subject=ContractPharmaSurveyhttp://www.diteba.com/http://www.diteba.com/mailto:[email protected]?subject=ContractPharmaSurvey


2/22

2010 OUTSOURCING SURVE

2010 CONTRACT PHARMA OUTSOURCING SURVEY Sponsored byDiteba Research Laborator2 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com

2010 OUTSOURCING SURVEY

Respondents who report that their outsourcing spending

GREW in the previous year: 43.9%

WHAT DOTHEY DO?

R&D ................................................................................18.5%Corporate Management..................................................15.3%QA/QC/Validation............................................................10.5%Project Manager..............................................................10.5%

WHERE DOTHEYWORK?

Top 20 Pharma...............................................................28.2%Small/Mid-Tier Pharma...................................................16.1%Virtual Pharma................................................................14.5%Generic Pharma ...............................................................8.9%

WHATTYPES OF OUTSOURCING DO THEY MANAGE?*

Analytical & Testing Services..........................................50.0%Manufacturing: Fill/Finish.................................................37.1%Methods Development / Validation..................................37.1%Process Development / Scale-Up....................................37.1%Stability Studies..............................................................36.3%Manufacturing: Solid Dosage..........................................34.7%Formulation Development...............................................33.1%

Respondents who report that their outsourcing spend

SHRANK in the previous year: 33.9%

WHAT DOTHEY DO?

R&D ................................................................................25.0QA/QC/validation ............................................................14.6Corporate Management..................................................14.6Project Manager................................................................9.4

WHERE DO THEYWORK?

Small/Mid-Tier Pharma...................................................19.8Top 20 Pharma ...............................................................16.7Generic Pharma..............................................................12.5Top 10 Biopharma.............................................................9.4

WHATTYPES OF OUTSOURCING DOTHEY MANAGE

Analytical & Testing Services ..........................................47.9Manufacturing:API..........................................................30.2QA/QC............................................................................30.2Formulation Development...............................................29.2CMC................................................................................25.0Methods Development / Validation .................................25.0Stability Studies..............................................................25.0

Past Imperfect

* Respondents can select multiple answers for this categor
http://www.diteba.com/http://www.contractpharma.com/http://www.diteba.com/http://www.contractpharma.com/


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Respondents who project that their outsourcing spending

will GROW in the next year: 44.9%

WHAT DOTHEY DO?

R&D................................................................................20.3%Corporate Management...................................................11.7%QA/QC Validation.............................................................11.7%Project Manager..............................................................10.2%

WHERE DOTHEYWORK?

Top 20 Pharma...............................................................29.7%Small/Mid-Tier Pharma...................................................16.4%Virtual Pharma................................................................12.5%Generic Pharma..............................................................10.9%


Analytical & Testing Services..........................................49.2%Manufacturing: Fill/Finish................................................32.0%Methods Development / Validation .................................32.0%Stability Studies...............................................................31.3%Manufacturing: Clinical Trials Materials...........................28.9%CMC................................................................................28.1%Process Development / Scale-Up...................................28.1%

Respondents who project that their outsourcing spen

will SHRINK in the next year: 26.1%

WHAT DOTHEY DO?

R&D ................................................................................20.3QA/QC/validation ............................................................14.9Corporate Management..................................................13.5Project Manager..............................................................10.8

WHERE DO THEYWORK?

Top 20 Pharma...............................................................20.3Small/Mid-Tier Pharma...................................................18.9Generic Pharma..............................................................12.2Emerging Biopharma......................................................10.8


Analytical & Testing Services..........................................41.9Formulation Development...............................................28.4Manufacturing:API ..........................................................27.0Process Development / Scale-Up....................................27.0Clinical Trials (Phase I-IV)...............................................25.7Manufacturing: Fill/Finish................................................25.7Manufacturing: Solid Dosage..........................................25.7

Future Shock



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Of the respondents who say that their companies outsource at least 50% of their commercial manufacturing . . .

59.4% report that more than half of their outsourcing dollars go to preferred providers

78.1% report that their company have never received a warning letter due to an inspection at a CMO

51.6% either probably or definitely will not outsource a project to Asia in the next year

81.3% are would use the word partnership to describe their relations with a provider

31.7% report that they have canceled or delayed outsourcing projects in the past year, due to the economy

are most likely to work at a Virtual Pharma (32.8% of respondents), and also predominantlyoutsource more than half of clinical materials (85.2% of respondents) and APIs (88.9% of respondents)

Commercial Interruption


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Ups and Downs

50% of all respondents said that they describe their outsourcing model asStrategic (entire classes of functions performed out-of-house), down from 55% last year.

The other 50% said they would describe their outsourcing model asTactical (case-by-case, based on availability).

Virtual Pharma companies were most likely to call their relationship Strategic (70%),

while Small/Mid-Tier Pharma was most likely to call their relationship Tactical (63%).

The largest group to say it will do 10+% more outsourcing next year

describe their companies as Top 20 Pharma, at 28%.

That was also the demographic that said it will do 10+% less outsourcing in the next year,

with 19% of the responses to that question.

8% of respondents said that their companies hadreceived a regulatory warning letter because of an inspection at a CMO;

72% said they had not and 20% were not certain.


6/22


2010 CONTRACT PHARMA OUTSOURCING SURVEY Sponsored by Diteba Research Laboratorie10 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com


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8/2214 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com


THE GLOBAL SOURCE FOR PHARMACEUTICAL AND BIOPHARMACEUTICAL

CONTRACT SERVICES AND OUTSOURCING

IN PRINT

ONLINE

WWW.CONTRACTPHARMA.CO

WEEKLY E-NEWSLETTCPDIRECT

CONTRACT PHARMA is the premier global news source dedicated to

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CONTRACT PHARMA covers all the bases with the latest breaking news and editorial feature

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9/22




Howmuchdidyouroutsourcingspending

changeinthepastyear?(byoutsourcingdecision)

Total

Analytical & Testing Services..........................................46.5%

Formulation Development...............................................28.8%

Stability Studies..............................................................28.2%

Manufacturing: Fill/Finish.................................................27.8%

Process Development / Scale-Up....................................27.8%

Methods Development / Validation..................................27.8%

Manufacturing:API ..........................................................27.5%

CMC................................................................................26.6%

Manufacturing: Solid Dosage..........................................25.9%

Clinical Trials (Phase I-IV)...............................................25.9%

R&D Services.................................................................25.3%

QA/QC............................................................................25.3%

Manufacturing: Clinical Trials Materials...........................24.7%

Chemistry........................................................................21.2%

Manufacturing: Injectable Dosage...................................21.2%

Manufacturing: Biologics, Finished Dosage....................20.3%

Drug Delivery Systems ...................................................19.9%

Packaging: Clinical..........................................................19.6

Manufacturing: Biologics, Bulk........................................19.3

Regulatory Filing.............................................................18.7

Manufacturing: Parenterals.............................................18.7

Packaging: Commercial ..................................................18.4

Validation Services..........................................................17.7

Labeling...........................................................................17.1

Supply Chain Management ............................................16.1

Preclinical / Toxicology....................................................14.6

Microbiology....................................................................13.6

Sterility Testing................................................................12.3

Manufacturing: Oral Liquid Dosage ................................12.0

Logistics...........................................................................11.4

Manufacturing: High Potency...........................................11.4

Clinical Logistics...............................................................9.2

Sales.................................................................................8.9

IT ....................................................................................5.4

Outsourcing Decisions

WHATTYPES OF O UTSOURCING DECISIONS AREYOU INVOLVED IN?*

* Respondents can select multiple answers for this catego


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WHAT DOTHEY DO?

Marketing/Sales..............................................................29.4%Project Manager..............................................................23.5%

R&D.................................................................................11.8%Business Development....................................................11.8%

WHERE DOTHEYWORK?

Top 20 Pharma................................................................41.2%Top 10 Biopharma ...........................................................17.6%Small/Mid-Tier Pharma....................................................11.8%Specialty Pharma ............................................................11.8%


Analytical & Testing Services..........................................29.4%Clinical Trials (Phase I-IV)...............................................29.4%Sales...............................................................................29.4%CMC................................................................................23.5%Manufacturing: Biologics, Finished Dosage....................23.5%Packaging: Clinical..........................................................23.5%

Stability Studies..............................................................23.5%

HOW MUCH DIDTHEIR OUTSOURCING SPENDINGCHANGE FROM THE PREVIOUSYEAR?

10%+ less than previous year .........................................17.66-10% less than previous year .........................................5.9

Did not change ...............................................................29.4

1-5% more than previous year.........................................11.8

6-10% more than previous year........................................5.9

10%+ more than previous year.......................................29.4

HOW MUCH DO THEY EXPECTTHEIR OUTSOURCIN

SPENDINGTO CHANGE IN THE NEXTYEAR?

10%+ less than last year.................................................17.6

1-5% less than last year....................................................5.9

1-5% more than last year ................................................47.1

10%+ more than last year...............................................29.4

Reduce, Reuse, Recycle

This year, we added To reduce company size to our list of responses to the question, Why do you outsource?

Only 7.2% of that questions respondents chose that answer, so the sample set isnt much to go on.Still, heres a little info about that group.

* Respondents can select multiple answers for this catego


14/22




WHAT DOTHEY DO?

R&D................................................................................23.5%QA/QC Validation............................................................15.1%Project Manager...............................................................11.8%Corporate Management..................................................10.1%

WHERE DOTHEYWORK?

Top 20 Pharma...............................................................24.4%Small/Mid-Tier Pharma....................................................17.6%Virtual Pharma................................................................13.4%Specialty Pharma .............................................................9.2%


Analytical & Testing Services..........................................59.7%Stability Studies...............................................................37.0%Methods Development / Validation .................................36.1%QA/QC............................................................................33.6%Process Development / Scale-Up...................................32.8%Manufacturing: Fill/Finish.................................................31.9%R&D Services..................................................................31.9%

HOW MUCH DIDTHEIR OUTSOURCING SPENDING

CHANGE FROM THE PREVIOUSYEAR?

10%+ less than previous year.........................................16.8

6-10% less than previous year .........................................4.2

1-5% less than previous year............................................5.9Did not change................................................................21.8

1-5% more than previous year........................................14.3

6-10% more than previous year......................................14.3

10%+ more than previous year.......................................22.7

HOW MUCH DO THEY EXPECTTHEIR OUTSOURCIN

SPENDINGTO CHANGE IN THE NEXTYEAR?

10%+ less than last year ..................................................8.4

6-10% less than last year .................................................5.9

1-5% less than last year....................................................5.0

Will not change................................................................31.9

1-5% more than last year.................................................17.6

5-10% more than last year..............................................12.6


I Would Prefer To

46.5% of respondents said that more than half of their outsourcing dollars go to preferred providers.

* Respondents can select multiple answers for this category


15/22




Specific class of APIs

Tech transfer to CMO

Analytical services

Synthesis

Alternate clinical dosage forms

Analytical testing Re-packaging and pre-clinical services

BE Studies

Phase I API manufacturing

Early phase

CMC devleopment

Contract synthesis delayed

Phase III trial and CMO production

Phase II clinical trials

Capital intensive

Clinical and IND-enabling studies

New product types or innovations

Intermediate and API synthesis

Clinical trials

Late stage product

Delayed non-priority projects

Clinical manufacturing and packaging

Nutritional

API Manufacturing

Timelines shifted Validation support

Clinical development programs

CM C

Development

Clinical trials

Small chemistry and pathology services

Preclinical and CMC

Analytics, clinical trials

Tox studies

Scale-up

Lower priority candidates

Manufacture of CTM

Clinical Trials

Delayed start of API and CTM man

turing until toxicology or clinical resu

became available. Canceled API/CT

manufacturing if toxicology or trial

results were not as expected.

Any project that went down in the litime to market or future values

Tech transfers from one CMO to ano

to consolidate our outsourced base

Discovery programs

Basic chemistry was normally out-

sourced, but a low level of projects l

doing the work in house

Preclinical

Bulk biologics manufacturing optimi

tion

Difficult synthetic projects

Specialty formulation development

Phase I & II

Why Not Outsource?

More than a third of our respondents said that theyd cancelled outsourcing projects in past year,due to the economic climate. We asked them to describe the projects they delayed.


16/22




A PI Eary stage raw material only -

Pre-Starting material Chemistry services (5 kg, non-cGMP)

Clinical trials Bulk drug intermediates and APIs A PI Solid dosage chemical Pilot clinical study and possibly

API sourcing Bioanalytical method transfer &

validation as a feasibility exercise All projects Manufacturing Molding parts Preclinical PK studies Non-GLP CMO and release testing Currently we are already outsourcing

API and manufacturing Custom raw materials and intermediates

IT Formulation development Manufacturing for market access in Asia Intermediates development Very competitive generic

manufacturing requirements API raw material synthesis stability Formulations from India Pharmacovigilance Established product API and API intermediates to Asia

no drug product! Second line Formulation and analytical development Biologic manufacture Phase I Analytical chemistry Ones where cost is a driver Basic stability and formulation work CN S Simple, early stage only

Commercial manufacturing Lower risk projects where the cost

savings are big enough to justify the Low IP, commodity product Medicinal chemistry

Clinical trials & CMC Small Molecules Criteria has not been defined as ye Follow-on biologic Toxicology Fill/Finish Project without proprietary know-ho Exploratory work Low IP risks Non-GxP, discovery support Development projects a few steps a

from the API Only as a test Clinical trial management and disco

work Clinical supply or testing for local m Less quality critical projects

What sort of project would you be

comfortable with outsourcing to Asia?

Note: Some respondents who said they were likely to outsource projects to Asia declined to provide an example.API or some variety thereof was the most common response.


17/22


2010 CONTRACT PHARMA OUTSOURCING SURVEY Sponsored by Diteba Research Laboratorie

0 25 50 75 10

32 2010 CONTRACT PHARMA OUTSOURCING SURVEY www.contractpharma.com


0.00% 0.25% 0.50% 0.75% 1.00%

0.00% 0.25% 0.50% 0.75% 1.00%


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35% of respondents said that theyHAVE cancelled an outsourcing project

in the past year due to the economy

WHAT DOTHEY DO?

R&D.................................................................................27.8%Corporate Management..................................................20.3%Purchasing/Sourcing........................................................11.4%QA/QC Validation ..............................................................7.6%

WHERE DOTHEYWORK?

Small/Mid-Tier Pharma...................................................22.8%Top 20 Pharma ...............................................................19.0%Specialty Pharma ............................................................11.4%Generic Pharma..............................................................10.1%


Analytical & Testing Services..........................................54.4%CMC................................................................................39.2%Process Development / Scale-Up...................................38.0%R&D Services.................................................................36.7%Methods Development / Validation .................................35.4%Stability Studies..............................................................35.4%Packaging: Clinical..........................................................34.2%

65% of respondents said that theyHAVE NOT cancelled an outsourcing project

in the past year due to the economy

WHAT DOTHEY DO?

R&D ................................................................................19.0QA/QC/validation ............................................................16.3Project Manager..............................................................12.9Corporate Management..................................................12.2

WHERE DO THEYWORK?

Top 20 Pharma...............................................................23.1Small/Mid-Tier Pharma...................................................16.3Virtual Pharma................................................................12.9Generic Pharma..............................................................10.2


Analytical & Testing Services..........................................51.0Manufacturing: Fill/Finish................................................32.0Methods Development / Validation .................................32.0Manufacturing:API..........................................................30.6Stability Studies..............................................................30.6Formulation Development...............................................29.9Process Development / Scale-Up....................................27.9

Cancellation Policy



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HOW MUCH DIDTHEIR OUTSOURCING SPENDINGCHANGE FROM THE PREVIOUSYEAR?

10%+ less than previous year.........................................31.6%

6-10% less than previous year .........................................8.9%1-5% less than previous year............................................6.3%

Did not change................................................................13.9%

1-5% more than previous year..........................................8.9%

6-10% more than previous year........................................8.9%

10%+ more than previous year .......................................21.5%

HOW MUCH DO THEY EXPECTTHEIR OUTSOURCINSPENDINGTO CHANGE IN THE NEXTYEAR?

10%+ less than last year.................................................15.2

6-10% less than last year .................................................6.31-5% less than last year....................................................3.8

Will not change...............................................................20.3

1-5% more than last year................................................20.3

6-10% more than last year..............................................10.1


More on Cancellations

About those 35% who said they have cancelled outsourcing projects in the past year:

48.1% of them said that they outsource to focus on core competencies.

Only 8.9% said that they outsource to reduce company s


20/22



0 1 2 3 4 5 0 1 2 3 4

0 1 2 3 4 5 0 1 2 3 4




21/22



0 1 2 3 4 5 0 1 2 3 4

0 1 2 3 4 5 0 1 2 3 4



0 1 2 3 4 5 0 1 2 3 4 5

0 1 2 3 4 5 0 1 2 3 4 5


22/22



What is your biggest complaint about

Contract Service Providers youve worked with in the past?

Heres an edited selection of what our respondents had to say.Timeliness / On-Time deliverywas the #1 complaint, with Quality issuesrunning a close second.

Misrepresentation of capabilities Asian CSPs not adhering to timelines Timeline commitments and GMP complaince on shop floor,

both with manufacturing and QA/QC

Audit scheduling Don't stick to timelines agreed upon up front Unreliable supply

Late with reports Missed protocol activities Keeping projects on schedule Reliability

Failure to deliver in a timely manner Timeliness Staff turnover

Prompt communication of problems Over-promising For some CSPs, GMP concepts and practices not "current"

with industry and regulatory trends

Faster communication and feedback. Lack of stability of employees at a CRO Cost

The cost and time at time of bid is markedly different fromthe final outcome

Lack of responsiveness Ease of doing business

Attrition and retraining Poor quality Do not take ownership of projects Product quality

Communication issues Lack of effective communication about a projects progress Poor project management

On-time delivery Not reliable Needs too much hand-holding and management Quality and yield

Overcommitment The committment Cost increases

Big gaps between claims and actual capabilitiesduring initial discussions

Conformance to tech transfer schedules and late deliveries

Over budget and longer than promised timelines Priorities driven by the almighty $ rather than relationship Poor quality and CGMP adherence Mis-communication.

Data transfer Not meeting timelines Flexibility Lack of commitment to the sponsor's needs

Not dedicating seasoned personnel to our project Lack of information sharing. Understanding flexibility needed for clinical work

Poor contingency planning Lack of open-book pricing Time to release results Increasing costs of services

Start-up is always great but close-down is alwaysa tough time

Poor communication

Internal vs. external focus Contamination issues Ability to turn work over quickly Unresponsive or minimal response to suggestions

Lack of experience in a key area that was originally statedto be a competency

Changes in project scope

Not service oriented Expectations not consistent with actual results Not being able to talk to the person doing the work Insufficent technical resources

Lack of ownership of the project Their inability to view the alliance as a partnership Communication gaps

Increasing study budgets; CRO was not willing to takeresponsibility for its own feasibilities.

Delay of the API delivery Billed for work not in the protocol

Incremental charges Schedules Quality On-time delivery

Inability to understand customer needs fully We dont have too many complaints, but with those providers

that we decided not to use again, there was

an inability to meet timelines, a lack of understandingof what it takes to get a NCE into Phase III, and weakanalytical know-how

Failure to be transparent about issues

Inability to translate provided study designs into appropriatetime and cost proposals

Under-resourced

Lack of awareness of cGMP Lack of established and reproducibile business systems Contract / agreement negotiations too long

Lack of communication Incomplete quotes Rarely take an owner's perspective Making changes without providing notification

Too hard to set up and work with each one individually Inability to say NO Slow response to inquiries (poor communication). Maintaining attention to small customer.

Higher cost / lower quality than the hype for outsourcing inIndia/China

The Science Of Research

At DiTEBA, we are committed to your success by providing

analytical and bioanalytical chemistry services that accelerate

R&D intensive projects.

As a pharmaceutical contract research organization, we strive

to be an innovative and cost-effective partner that delivers

consistent, quality services with unmatched integrity.

Through the science of research, let DiTEBA expedite

the process of bringing your product to market.

1620Tech Avenue, Unit 3

Mississauga, ON Canada

L4W5P4

18006719053

90562579959056253767

www.diteba.com

[email protected]

Toll Free:

Phone:Fax:

Analytical Testing

Bioanalytical Testing

Stability Storage and Testing

Cleaning Verification and

Validation Testing

Formulation Development

Support Testing

In Vitro Release Rate Testing

Physical Testing

Rea

ResearchTurning Research Into Re
http://www.contractpharma.com/http://www.diteba.com/mailto:[email protected]?subject=ContractPharmaSurveyhttp://www.contractpharma.com/http://www.diteba.com/http://www.diteba.com/mailto:[email protected]?subject=ContractPharmaSurvey

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2010 CP Outsourcing Survey

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