pcmg annual conference 2018 50 shades of outsourcing · poland medicover poland dziuba, julia 27...

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PCMG 2018 – 50 SHADES OF OUTSOURCING

PCMG Annual Conference 201850 SHADES OF OUTSOURCINGFriday 8th June 2018


A huge thank you to all our sponsors

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Please note:

To avoid breaching any competition legislation, participantsare reminded not to engage in any discussion which couldbe considered potentially anti-competitive. These include(but are not limited to) information regarding pricing,market shares, terms of sales, investment plans, individualterms of business or any other action which may restrictcompetition. Participants are also reminded to adhere totheir company polices and should inform the organisersabout any discussion which could breach their policies orthe competition legislation.

www.pcmg.org.uk 3


Lewis Cameron, Covance InternationalJames Featherstone, Syneos HealthPaul Hargreaves, Century HouseConsulting

Keynote session: Change survival,management or leadership?

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PCMG 2018 – 50 SHADES OF OUTSOURCINGwww.pcmg.org.uk 5

Kindly sponsored by

Sessions resume at 10:45


PCMG Annual Conference 201850 SHADES OF OUTSOURCINGWhen Freakonomics meets PCMG….

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As voted by the 2018 PCMG conference attendees , you told ussomething that will change the way we think, or work, and that we didnot know.

For that, we are all very grateful. You are our very own SUPER FREAK !

Freakonomics

The Hidden Side of Everything

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PCMG Annual Conference 201850 SHADES OF OUTSOURCINGMobile Technology –

Redefining Clinical Trials

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Sleep

Physical Activity

Posture

Heart Rate

Respiration Rate

Galvanic Skin Response

Cough

Respiratory Sounds

Seizure

PD Symptoms

Weight

Blood Pressure

Oximetry

FeNo

CGM

Gait Assessment

Voice Analytics

Fine Motor Skills

Temperature

Spirometry

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7.1M Patients Use RemoteMonitoring, ConnectedMedical Devices- BergInsights 2017

83% healthcareOrganizations said they arehighly likely to invest in

telehealth. -ATA

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PharmaPharma

PatientsPatients

HealthcareHealthcare

97.6M mHealth WearableDevices to Ship Yearly by2021

Connected wearabledevices increase from 325million in 2016 to over 830million in 2020.

93% of physicians believethat mobile health appscan improve patient’shealth. – GreatCall

74% of hospitals that usemobile devices to collecthealthcare data are moreefficient than those who

don’t. – Ricoh Research


IOHT

$28 Billion mHealth (Mobile Healthcare) Ecosystem Market 2018-2030-PRNewswire

$28 Billion mHealth (Mobile Healthcare) Ecosystem Market 2018-2030-PRNewswire

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PCMG 2018 – 50 SHADES OF OUTSOURCING15

18501005001000150020002500300035004000450050005500600065007000750080008500900095001000010500110001150012000125001300013500

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The Virtual Trial

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PCMG 2018 – 50 SHADES OF OUTSOURCING 17


PCMG Annual Conference 201850 SHADES OF OUTSOURCINGWhen Freakonomics Meets PCMG…Dawn Anderson

Managing Director, Deloitte Consulting

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The Future of Clinical…

…is closer than you think

www.pcmg.org.uk 19

Robotic ProcessAutomation

Software used to automate basic tasks such astransaction processing, data manipulation, and

communication across multiple IT systems

Screen scraping data collection

Rules based business process management

Tactical toolset to automate repetitive tasks

Cheaper and faster step towards process efficiency

CognitiveAutomation

Automation of non-routine tasks involvingintuition, judgment, creativity, persuasion, or

problem solving

- Deloitte, “Automate This”

Data input and output in any format

Pattern recognition within unstructured data

Replication of judgment based tasks

Basic learning capabilities for continuous improvement toquality and speed

ArtificialIntelligence

“The theory and development of computersystems able to perform tasks that normallyrequire human intelligence.”

- Deloitte, DU Press “Cognitive Technologies”

Natural language recognition and processing

Dealing with unstructured super data sets

Hypothesis based predictive analysis

Self-learning rules continuously rewritten to improveperformance

Maturing Emerging

Co

mp

lexit

y

Time

Stag

es

of

Au

tom

atio

n

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Hello, Dawn, how can I help youtoday?

How many sites are open in ProjectTiger?

The next visit for site 9 isscheduled for Monday, July 16,2018

12 sites areopen

How many patients are enrolled inProject Tiger?

42 patients areenrolled

When is the next monitoring visit atsite 9?

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Hey Daphne. How many sites are notmeeting enrollment targets inCanada?

Dr. John Smith is the PI at Site17.

2 sites are not meeting enrollmenttargets in Canada

Which sites are not meetingenrollment targets in Canada?

Site 6 and Site 17 are not meetingenrollment targets in Canada.

Who is the PI at Site 17?

Call Dr. JohnSmith

Calling Dr. John Smith

Hello, Dawn, how can I help youtoday?

Country Site Name Investigator NameEnrollment Rate(patient/month)

Site Activation Time(months)

Poland University Hospital in Krakow Porowski, Aleksander 12 5.1

Poland Medicover Poland Dziuba, Julia 27 3.5

Poland University Clinical Center Lacki, Alicja 21 2.6

Poland St. Sophia Hospital, Warsaw Koscinski, Szymon 6 4.2

Brazil Hospital Israelita Albert Einstein Santos, Joao 8 2.6

Brazil Hospital de Clinicas de Porto Alegre Silva, Sonia 29 3.1

Brazil Hospital do Coracao Paraiso Ferreira, Leonardo 54 4.6

Brazil Fleury Medicina e Saude Oliveira, Ana 15 5.1

Brazil Hospital Sao Luz Carvalho, Guilherme 32 3.3

Country Site Name Investigator NameEnrollment Rate(patient/month)

Site Activation Time(months)

Poland University Hospital in Krakow Porowski, Aleksander 12 5.1

Poland Medicover Poland Dziuba, Julia 27 3.5

Poland University Clinical Center Lacki, Alicja 21 2.6

Poland St. Sophia Hospital, Warsaw Koscinski, Szymon 6 4.2

Brazil Hospital Israelita Albert Einstein Santos, Joao 8 2.6

Brazil Hospital de Clinicas de Porto Alegre Silva, Sonia 29 3.1

Brazil Hospital do Coracao Paraiso Ferreira, Leonardo 54 4.6

Brazil Fleury Medicina e Saude Oliveira, Ana 15 5.1

Brazil Hospital Sao Luz Carvalho, Guilherme 32 3.3

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Are you ready?

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Managing risk by your failures -Quality Tolerance Limits –Or 50 Shades of Quality

Andy Lawton, Risk Based Approach Ltd

PCMG, Malta, 8th June 2018


QbD and Clinical Trials1 2

Which image best represents the pharma industry approach toClinical Trial quality?

A. Image 1B. Image 2

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Which image best represents the pharma industryapproach to Clinical Trial quality?

A. Image 1

B. Image 2

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Imag

e 1

Image 2

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77


QbD and Clinical Trials

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ICH E.6 R2 section on QTL

5.0.4 Risk Control

Predefined quality tolerance limits should be established, taking into

consideration the medical and statistical characteristics of the variables

as well as the statistical design of the trial, to identify systematic issues

that can impact subject safety or reliability of trial results. Detection of

deviations from the predefined quality tolerance limits should trigger an

evaluation to determine if action is needed.


StatisticalQualityControl

1930’s

Total QualityControl

1956

StatisticalProcessControl

1960’s

CompanyWide Quality

Control

1968

Total QualityManagement

1985

Six Sigma

1986

Application ofstatisticalmethods,control chartsandacceptancesampling, inquality control

Stress oninvolving otherdepartmentsin addition toproduction.e.g. Finance,HR, etc

Inspired bycontrolsystems, useof controlcharts tomonitorindividualindustrialprocess

Japanese styletotal qualitycontrol

Originatingwith USDepartmentof Defence

Statisticalquality controlas applied tobusinessstrategy

Tolerance Limits

Shewhart Deming

JuranQuality by Design

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Total errors in aclinical trial for a

parameter

Systematic Errors =“errors that matter”

RandomErrors

Expectation

Upper QTL

Lower QTL

Quality Tolerance Limits

Some suggested areas touse in• Protocol deviations• Adverse events• Data changes• Lost to follow-up


Time

Errors,PV’s,

IssuesSYSTEMATIC

RANDOM

Do

StudyAct

Plan

Do

StudyAct

Plan Decrease in Systematicissues over time!

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Summary: What can ToleranceLimits give us

Tolerance Limits

Defined Quality

Quality ReportCSR sect 9.6

ContinuousQuality

Improvement

Compliance atEntry

Reduce burdenfor company and

site

ReduceInspection issues

KnowledgeManagement

Trial simulation

MergingDisparate data

Quality byDesign


Q & A

Contact: [email protected]

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What are your companies doing with QTLs?

A. Do not know

B. Nothing yet

C. Piloting

D. Implemented fully

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Donot kn

ow

Nothin

g yet

Pilotin

g

Imple

mente

dfu

lly

2

0

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As voted by the 2018 PCMG conference attendees , you told ussomething that will change the way we think, or work, and that we didnot know.

For that, we are all very grateful. You are our very own SUPER FREAK !

Freakonomics

The Hidden Side of Everything

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And the winner is…?

A. Dawn Anderson

B. Marie McCarthy

C. Andy Lawton

www.pcmg.org.uk 39

A. B. C.

26%

16%

58%


Otis Johnson, ICON plc

How is Real World Data informinghealthcare decision making?

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How is Real World Data InformingHealthcare Decision Making?

Otis Johnson, PhD, MPA For Presentation at PCMG ConferenceMalta, June 8, 2018Vice President, Feasibility & Clinical

Informatics, ICON PLC

How much data are we generating every 2 days?

A. As much as we created in all of2010

B. What we created from 1990 to2000

C. As much as we created from thebeginning of time until 2003

D. A whole lot

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A. B. C. D.

12

28

37

20

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What is 5 Zettabytes?

43

5 million million GB

By 2020, close to 50 ZB

Over 5000 GB per personDeriving less than 15% ofvalue from all this data

RWD Informs Clinical Decision MakingLikelihood of success drops precipitously after 6 months of treatment with basal insulin

Time to glycemic control with HbA1c ≤7%

ReferenceStacey, J., Hildebrand, S., & Stapff, M. 2018. A real-world data analysisevaluating the time to glycemic control after Initiation of basal insulin intype II diabetic patients . ISPOR Annual Meeting, Baltimore, MD

Skin CancerDiagnosis

Dermatologists

Neural Network

88%

95%

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How is Real World Data Informing Healthcare Decision Making?

• Treatment guidelines

• Diagnostic support

• Replication of published studies

Clinical caredecisions

Clinical researchdecision making

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• Study design decisions• Placement of studies• Objective patient voice• Patient recruitment decision

support

Slow unpredictablerecruitment

• Unmet expectations• Delayed filings• Lost revenue• Damaged relationships

Opportunity for Improved Response to Slow Enrollment

Typical response to slow enrollment

Add countries

Add sites

Revise protocol

Implement remediation programs

Organizational culturethat supports innovationand change

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Opportunity to use RWD in planningand delivery of clinical trials?

Validate and refine protocol usingreal patient data

Predict problematicinclusion/exclusion criteria

Gain early insights into expectedtrial performance

Plan mitigations from the start

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What proportion of discovered compounds makes it from thelabs to market?

A. 1 in 1,000

B. 1 in 5,000

C. 1 in 10,000

D. 1 in 30,000

Cook et al., 2009 A. B. C. D.

2

37

48

7

Complex Query to Evaluate Inclusion/Exclusion Criteria… and Find theTargeted Statin Intolerant Patients

Inclusion Criteria Exclusion Criteria

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Consider Exclusionary Time Frames… to Identify the Targeted Patient Population

Exclusion Criteria – Last 12 months

Exclusion Criteria – Last 36 months

Exclusion Criteria – Malignancies

Characteristic of Targeted Patient Population & Where to Find Them980 Matching Patients Across 28 Health Care Organizations

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Use Historical and Predicted Arrival Rates to Inform Patient Recruitment Efforts

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– Metabolic Panel

– CBC

– Liver Function

– Coagulation

– Cardiology

– Endocrinology

Granular Medical Profile of Patient CohortUse to Adjust Inclusion/Exclusion Parameters

– Iron

– Microbiology

– Tumor Markers

– Other Chemistry

– Findings

– Vitals

Potential Patients Identified in Last Year

Criteria Pts Comments

Diagnosed with disease and

met age range requirement 3085 Matched selected ICD9 codes

Seen in last year 1316 Patient considered active

# of the above who also have their most

recent A1C < 11 1125Several patients with no A1C data in

last year# of the above who also pass exclusion

criteria #1 819 See source for details.# of the above who also pass exclusion

criteria #2 370 See source for details.# of the above who also pass exclusion

criteria #3 338 See source for details.

Acceptable BMI 300 See source for details.

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Attrition Funnel to Show Effect of Key Study Criteria

Indication Specific Data Driven Feasibility – Site Perspective

Pre-Screen Screening Drop-Outs

-34% -55% -23%120 Potential Completed Patients

3 to 1 overall conversion ratio

347Eligible

156 Qualified

Site Historical DataAnalyzed and Applied

526 Patients Available

via EHR with HighCholesterol

Indication Trials in past 5 years Avg. % of Goal AchievedAvg. % Lost at Pre-

ScreeningAvg. % Lost at Screening

High Cholesterol 96 104% 34% 55%

Avg. % Lost Post RDZ Avg. # RDZ Per Trial Avg. Enroll. Period Enrollment Rate Avg. of Days to FPI

23% 7.3 4.3 mos. 1.7 pts/mo. 10

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How much does it cost to bring a drug to market?

A. 0.5-1 Billion

B. 1-2 Billion

C. 2-3 Billion

D.Over 3 Billion

Golec, et al. 2010 A. B. C. D.

1

12

60

23

Flag When Patients May Become EligibleMost Common Treatment Pathways in Eligible Patients

TransMed Systems, Inc.

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EHR Criteria Assessed: Protocol 1

Protocol 1 Screen Failure Reasons

0

50

100

150

200

250

300

350

Incl

1

Incl

2

Incl

3

Incl

4

Incl

5

Incl

6

Incl

7

Incl

8

Incl

9

Excl

1

Excl

2

Excl

3

Excl

4

Excl

5

Excl

6

Excl

7

Excl

8

Excl

9

Excl

10

Excl

11

Excl

12

Excl

13

Excl

14

Excl

15

Excl

16

Excl

17

Excl

18

Excl

19

Excl

20

Excl

21

Excl

22

Excl

23

Excl

24

Excl

25

Excl

26

Excl

27

Excl

28

Incl

10

V2

Incl

11

V2

Incl

12

V2

Excl

29

V2

Excl

30

V2

Excl

30

V2

Incl

13

V3

Incl

14

V3

Incl

15

V3

Incl

16

V3

Incl

17

V3

Excl

32

V3

Excl

33

V3

Excl

34

V3

Reason

No.ofP

atients

•EHR does not always have allinformation needed for clinical trialdecision making

Risk: Inaccurateconclusion

EHR vs. Actual Screen Failure Reasons

Protocol 1 Screen Failures: EHR Assessment Vs Actual

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

45.0%

50.0%

IC S/ LA B A o r

SA B A

Smo kers Hyp er t ension R ecent C l inical

Tr ial

Lung D isease R enal o r

Hep at ic

D isease

Lab

A b no rmali t ies

Ot her

M ed icat io ns

Screen Failure Reason

Perc

enta

ge

ofAssessed

Scre

en

Failure

s

EMR Actual

Some parameters change over time

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Actual Screen Failures as a Proportion of all Patients Screened

Frequency of Inclusion and Exclusion Criteria in Protocol 2

0

1

2

3

4

5

6

7

8

9

Incl

1Incl2

Incl

3

Incl

4

Incl

5

Incl

6

Incl

7

Exc

l 1

Exc

l 2

Exc

l 3

Exc

l 4

Exc

l 5

Exc

l 6

Exc

l 7

Exc

l 8

Exc

l 9

Exc

l 10

Exc

l 11

Exc

l 12

Exc

l 13

Exc

l 14

Exc

l 15

Exc

l 16

Exc

l 17

Exc

l 18

Exc

l 19

Exc

l 20

Exc

l 21

Exc

l 22

Exc

l 23

Exc

lu24

Exc

l 25

Inclusion or Exclusion Criteria

Num

berofPatients

Exclu

ded

•May find what’s needed in certaindisease areas•Know what you need

Success Measures

Success Measures

EHR-enabled sites vs. traditionalsites

Comparison to industrybenchmarks

Ability to flag enrollmentchallenges

Expectations

Protocol Refinement

Investigator Identification

Patient Recruitment

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Predictability Infrastructure in Place –Track Studies As They Are Completed

Organizational Change Statistics:What percent of mergers & acquisitions (M&As) fail?

A. 10-20%

B. 25-50%

C. 50-80%

D. 80-90%

Budhwar et al., 2009 A. B. C. D.

1 111

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Sessions resume at 13:15


Andrew Copestake, TFS LtdDave Webber, Gilead Sciences

Change orders: how to minimize the painof this necessary evil?

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Agenda

•Survey Results – Setting the Scene

•Fundamentals

•The Spectrum of Outsourcing Approaches

•How Do We Move Forward?

•Summary & Conclusion

www.pcmg.org.uk *


Have you ever thought they were buying amini….

*

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And end up paying for a Ferrari!

*

PCMG 2018 – 50 SHADES OF OUTSOURCINGwww.pcmg.org.uk

Or as a provider, asked to paint this..

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PCMG 2018 – 50 SHADES OF OUTSOURCINGwww.pcmg.org.uk

And end up painting the Forth bridge!!


Whatever your experience is..

•Sponsors are looking to minimise costs andmaximise delivery

•Providers need to make a profit!

www.pcmg.org.uk *

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PCMG Survey

www.pcmg.org.uk *


For Sponsors only: What is your predominant outsourcing approach?

41.94%

19.35%

35.48%

3.23%

Sponsor

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

40.00%

45.00%

Full service Functional service (FSP) Hybrid Other

*

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Sponsors only: What is your predominantcontracting approach?

29.03%

58.06%

9.68%

3.23%

Sponsor

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

Fixed price Fixed unit price Time and materials FTE

*


Allowing for fluctuations in the total volume of study contracts, over thelast 3 years has the number of change orders you deal with generally?

32.26%

3.23%

64.52%

Sponsor

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

Increased Decreased Remained about the same

37.14%

2.86%

60.00%

Provider

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

Increased Decreased Remained about the same

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Do you consider change orders to have a negative impact on your projectsand/or relationship with your counterpart?

58%

46%42%

54%

0%

10%

20%

30%

40%

50%

60%

70%

Sponsor Provider

Yes No


Sponsor Only - Has the prevalence of change orders impacted youroutsourcing approach?

41.94%

58.06%

Sponsor

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

Yes No

• Moved to fixed price• Moved to FSP from full service• Focused on detailed SOW up front• Include risk sharing model• Fixed less complex studies• Increased line items in responsibilities• Change order management now a selection

criteria, some activities brought in house

*

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What do you think is the main reason driving change orders?

29.03%

32.26%

0.00% 0.00%

12.90%

9.68%

16.13%

Sponsor

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

Poor study planning Poorly defined study specifications

Unforeseeable external factors CRO performance

Sponsor changes in strategy Sponsor changes in scope

Other (please specify)

5.88%

23.53%

11.76%

0.00%

26.47% 26.47%

5.88%

Provider

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

Poor study planning Poorly defined study specifications

Unforeseeable external factors CRO performance

Sponsor changes in strategy Sponsor changes in scope

Other (please specify)

*


For Provider only: Does your financial forecast include an allowance forchange orders?

41.18%

58.82%

Provider

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

Yes No

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What recommendations do you have to eliminate/reducechange orders?

Sponsor

• Joint risk management• Better planning• More accurate predictions from Providers• Build in contingencies• Clearly define strategy, scope and R&R’s• Less breakdown of budget• Fixed price with costed risk mitigation

Provider

• Accept it, its going to happen• More realistic expectations from Sponsors• Close communication from start• Allow for protocol amendments• Risk Share• Smaller closely defined work packets• A buffer with agreed thresholds• Implement CRO recommendations• Robust upfront planning• Sponsors avoid driving initial budget too low


Fundamentally for the Sponsor its about3 things•How you specify what you want up front

•How you will pay for it

•How you deal with change

*

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Fundamentally for the Provider its alsoabout 3 things•Understanding the Sponsor expectations &

interpreting their specifications

•Pricing it accordingly and in a way that will makeyour solution commercially attractive to both

•How you’ll deal with change


Setting Specifications

• How much detail is enough

• How much input does the provider have –are you fully aligned at the outset

• Building the plane whilst flying it!

www.pcmg.org.uk *

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Payment Considerations

•By person (FTE based)

•By task/activity

•By deliverable

•Sponsors looking to pay for activities ordeliverables

•CROs need to ensure FTEs are fully utilized

www.pcmg.org.uk


Dealing with Change/Risk

• Risk mitigation - contingencies• Clear understanding of accountability – risksharing, risk transfer, sponsors still heavilyinvolved in decision making and conduct

•Sponsors wanting to put risk onto CRO•CROs concerned about things“outside of their control”

www.pcmg.org.uk

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There is a spectrum of outsourcing approaches

Outsource for Capacity• Sponsor manages and makes all

decisions• CRO commits to provide trained

resources (FTEs)• Sponsor manages all risk• CRO follows Sponsor processes• Contract scoped at high level, pay for

FTEs

Outsource for Expertise• CRO manages and makes all

operational decisions (withinparameters)

• Sponsor performs oversight• CRO commits to deliver to project• CRO manages risk within its control

with agreed mitigation plans• CRO follows own processes• Contract scope focused on outcomes,

pay for outcomes

*


In Practice there is a confusing mix



resources (FTEs)• Sponsor manages all risk• CRO follows Sponsor processes• Accountable only for provision of

resource• Contract scope at high level, pay for FTEs

Outsource for Expertise• CRO manages and makes all operational

decisions (within parameters)• CRO commits to deliver to project• CRO manages risk within its control with

agreed mitigation plans• CRO follows own processes• Accountable for delivery• Contract scope focused on outcomes,

pay for outcomes

• Sponsors need resources but consider theyretain the expertise

• Sponsor makes most of the decisions• Sponsor tries to hold the CRO accountable for

delivery with limited success• A mixture of sponsor and CRO processes are

used• Project scope is defined in great detail with

frequent changes leading to large number ofamendments and budget overruns

• There is little clarity around responsibility for riskmanagement

*

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In Practice there is a confusing mix



resources (FTEs)• Sponsor manages all risk• CRO follows Sponsor processes• Accountable only for provision of

resource• Contract scope at high level, pay for FTEs

Outsource for Expertise• CRO manages and makes all operational

decisions (within parameters)• CRO commits to deliver to project• CRO manages risk within its control with

agreed mitigation plans• CRO follows own processes• Accountable for delivery• Contract scope focused on outcomes,

pay for outcomes

• CRO not given time to adequately prepare theirbid

• CRO does not correctly asses the risks associatedwith project delivery

• A mixture of Sponsor and CRO processes areused

• Sponsors still insist on the project scope beingdefined in great detail

• Lack of transparency of CRO costs & profitmodels

• Poor alignment on how to agree on outcomesand assess project success


To Move Forward We Need to Consider• Finance teams at CROs and Sponsors like Fixed Price and Unit

based contracts because they feel it gives budget transparencyand control BUT Sponsor Units and CRO units are never thesame thing

• Sponsors need to accept that CROs need to make a profit BUTCROs need to be fully transparent about their costs and margins

• Joint focus on resources is needed to achieve study outcomes• Study progress assessed in the same way by both CROs and

Sponsors

www.pcmg.org.uk

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Example of a Shared View - EVA

CONFIDENTIAL


Conclusion

• Consider which end of the outsourcing spectrumyour corporate culture is most aligned with

• Agree deliverables and who is accountable for what• Jointly track performance/delivery using standardised

and industry accepted methods• Build in joint risk management• Take a more open, transparent and collaborative

approach

www.pcmg.org.uk *

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Has Anyone Figured It Out?

Questions?

www.pcmg.org.uk *


Simon Taylor – COO, Th3rd Curve

External perspective on defining scope andmanaging budgets to drive transparencyand build trust

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What’s up next?

• Who am I?

• Projects

• Estimating

• Change & Performance

• Contracts in Construction

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Me

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Me

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I really like thisslide template


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“Time is a constant and what has happened was always going to happen”

Someone – sometime AD


“on this basis what matters is did you know and how did you act”

me – all the time

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Projects

What are they?

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Projects

• Temporary – start and end

• Outcome based – lead towards a change

• Things that needs doing - sometimes in order

• Require resources – which need to be procured

• Require decisions – need information

• Adaptable – environments are changing

• Financed – governance and assurance

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Can we be the same?

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Define ExecutePlan Handover Utilise

Project Evolution – Life cycle

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Define ExecutePlan Handover Utilise

Project Evolution – Life cycleI feel muchbetter ^_^

Yay the drugsDO work!


Business Case

Governance

Procurement

Contract Management

Risk Management

Planning

Change Management

Performance Management & Reporting

all projects share thesame DNA

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Project issues – Construction orPharma?• Lack of trust between parties

• Drowning in irrelevant information

• Asymmetry of information

• High levels of late delivery and overspend

• High level of specification

• High levels of change


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A quick (ish) word on complexity

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Tackling complexity

Modern project and programme management is about

understanding and managing interfaces.


What is complexity?The Stephen Carver explanation

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The different types of complexity

Structural Complexity Bits

Emergent Complexity Change

Socio-political Complexity People


The 3 complexities

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We asked a group of 246 (top) Project Managers thesequestions

“In your work, which of the3 complexities is the mostdifficult to manage?”

“In your own formal trainingand development, which ofthe 3 complexities hasreceived the most attention?”

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Project Controls de-riskscomplexity

StructuralComplexity

Define

Socio-politicalComplexity

Direct

EmergentComplexity

Manage


Getting the estimate right

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Yay!!

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Estimating

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Cost estimating is the process used to quantify the cost of services,materials and resources required to deliver a project.An estimate should be robust and repeatable. The estimate shouldcontain the source information used to calculate the estimate andassociated assumptions.

The purpose of a cost estimate is to determine the likely cost of theproject. It may have a number of uses, for example to create budgets, todraft proposals, to tender for work or to get approval for research studies.Depending on its purpose, the scope and detail of the cost estimate willvary.


Risk management

Risk management is the practice of identifying,managing and modelling uncertainty.

Do research projects face uncertainty?

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Use integrated Information

Estimating Breakdown Structure, Work Breakdown Structure,Cost Breakdown Structure, Risk Breakdown Structure

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WBS CBSEBS RBSWidget

Site Visit PRJ01-SV-E-001 PRJ01-SV-W-001 PRJ01-SV-C-001 PRJ01-SV-R-001

You will have repeatability, tractability and be able to seevariations on each widget and why


Use Integrated Systems

• Estimating• Planning• Cost• Risk• Change• Contract management• Performance

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CostOsP6AconexARM

Unifier

Tableau

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Continuous Benchmarking

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£0

£1

£2

£3

£4

£5

£6

£7

£8

Jan Feb Mar Apr Jun July Aug

Site Visits

PRJ01-SV-E-001


Ideas for Pharma

• Focus contract incentives on deliverables that add value to the project –We want data so let’s align sponsor and CRO goals

• Introduce cost and risk modelling to the estimating process (P50, P80) –What’s our worst case scenario?

• Combine detailed estimates together into key deliverables – Have thedetail but don’t drown in it

• Continuous benchmarking for cost of activities, deliverables and patientdata – Let’s make our estimating a continuously viable tool

• Leverage integrated tools, data and processes to make life easy

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Managing change & Performance

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What is change?

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If it’s specified it’s a changeHow much can you process?

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Use systemisation and workflows

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NewScope

It’s withinPM

Authority

Impact isbelow

tolerance

It hasvalidated

cost

ChangeApprove

d

• Speeds upadministration

• Reduces errors

• Reduces impact toproject

• Cements accountability

• Increases certainty ofcost

Yay!!


‘The Golden Thread’

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Business CaseScopeRequirements

Time / Cost /Risk

Progress

Impact

Change

Time / Cost /Risk

Win

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‘The Golden Thread’

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Business CaseScopeRequirements

Time / Cost /Risk

Progress

Impact

Change

Time / Cost /Risk

Win

Impact of change must becorrelated across thread


Performance Dashboards

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StaticDynamic

Yay!!

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Continuous Benchmarking

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£0

£1

£2

£3

£4

£5

£6

£7

£8

Jan Feb Mar Apr Jun July Aug

Site Visits

PRJ01-SV-E-001


Know your information needs!

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Ideas for Pharma

• Deploy integrated data structures to yield benefits ofrich data

• Obsess over data quality

• Focus performance on deliverables that add value tothe project

• Continuous benchmarking for cost of activities,deliverables, patient data and completion date of project


Ideas for Pharma

• Introduce behavioural KPI’s – make them tangible

Accountable Fair &Consistent

Direct Collaborative Active

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Contracts in Construction

Building trust


WAI CHI-SING - HONG KONG DEVELOPMENT BUREAU“The main benefit of NEC3 contracts over conventionalcontracts is that they have partnering built in, encouraging thetwo contracting parties to work together to solveproblems...Overall it is NEC’s collaborative spirit that helps toimprove contract management, increase cost-effectivenessand improve project outcomes.”

DANIEL COOK - THE HIGHWAYS AGENCY“We use NEC Contracts across the board because they'reall collaborative, and we think working with suppliers ratherthan against them is the best way to achieve our objectives.They also represent really good management approaches;proactive in the way they deliver.”

DAVID ALLEN - CROSSRAIL“NEC3 helped deliver the largest civil engineering project inEurope, on budget and with value for money. NEC3 helpedthe project hit 45 out of its 46 targets last year, narrowlymissing only one.”

JON BROOME - ASSOCIATION FOR PROJECTMANAGEMENT (APM)“The Association for Project Management aims to raise thelevel of professionalism in the delivery of project, and one ofthe 3 principal objectives of NEC is to stimulate good projectmanagement - so there's a good joint interest.”

SIR JOHN ARMITT - OLYMPIC DELIVERY AUTHORITY“The use of the NEC3 family of contracts ensured that mostproblems were solved when they occurred, rather than endingup in the courts at the end of the process.”

PETER WALKDEN - MAGNOX“The NEC3 contract suite has become a cornerstone of theMagnox programme and has been used to great effect; fromthe adoption of better contract management techniques todriving a cultural change based around learning andcontinuous improvement. The contract managementprocesses and collaborative approach to working have helpedus deliver improved value for money in meeting the challengesfaced.”

“Working together in the spiritof mutual trust andcooperation”

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What is NEC?

• Stands for New Engineering Contract

• Suit of contracts designed with simple language in mindand collaboration at its core.

• Seeks to make adapting to change a core part ofadministration.

• Introduces behavioral terminology “spirit of mutual trustand cooperation”

• Provides out of the box incentivisation process (ECCoption C&D)


What are we trying to achieve?

•Patient safety is our top priority

•We value patient data

•We need it to be robustly captured andanalysed

•We need it quickly

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Make sure this iscontractual andworks for all

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What havewe learned?


• Don’t need to be a lawyer tounderstand it

• Looks to diffuse end of projectbattle

• Makes up front planningfundamental

• Built in incentives for both parties

• Progressive stance on change

• Clear processes and procedures

• Mature position on uncertainty

• Focus on early notification ofissues

• Introduces behavioral language

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• Focus on schedule can lead togaming

• Constant change means it’s hardto performance manage

• Change is viewed negatively byclient and positively by contractor

• Being contractual is often viewedas negative

• Lack of clarity and legalprecedent on behaviors

• High levels of administrationmeans high level of capability onboth sides


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Ideas for Pharma

• Bid defence now called Bid presentation

• Award, baseline and monitor via NEC like contract,focus on reducing risk and early completion

• Customer and supplier joint training on contract

• Focus payment on deliverables that add value to theproject


Ideas for Pharma

• Business case at heart, agree on value (patient data intime) and use one team approach to tender

• Incentivise via business case enrichment (data faster)pay on patient data in phases, (Faster means kill thedrug quicker)

• Introduce early warning and risk reduction meetings

• Introduce surgical strike reviews to address keycommercial or relationship issues

Ice cold,no

mistakes.

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Let’s keep the Happy Lawyers happy


So, can clinical researchlearn from construction?Hmmm……..yes

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Stuff by SiPresentation close

143www.pcmg.org.uk

•Project Managementworks for sectors

•Love data but Avoidthe Illusion of control

•Align your goals

•Good behaviors willhelp you succeed

Summary Points


David Davies, PCMG TreasurerSandra Johnson, PCMG Committee

Wrap up

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PCMG Annual Conference 2018


Consistency, Continuity,Consolidation,Collaboration, Change,Complexity & Competency

PCMG 2019Navigating 7 Cs ofOutsourcing &Procurement

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A CALL FOR 2019STEERINGCOMMITTEEMEMBERS

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1. FDA/China Regulatory changes and opportunities2. Making Academia work: PCMG working group3. Industry Consolidation impact and implications4. ClinDev and the Biological product supply chain5. Quality Assessment = Continuity & Consistency?6. Japan study volume vs. culture for outsourcing7. Speculative development/risk – out-of-industry case8. Medical devices and outsourcing, early learnings9. Consistency & continuity in the face of CHAOS

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2018 POST-CONFERENCE SURVEY

•WHAT DO WE MAINTAIN IN 2019

•WHAT DO WE NEED TO IMPROVE

•LINK TO PRESENTATIONS…..

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Thanks for comingSee you next year5th to 7th June 2019The Melia Hotel, Sitges,Spain

pcmg annual conference 2018 50 shades of outsourcing · poland medicover poland dziuba, julia 27...

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