vendor oversight track - fdanews.com · victory!) 1. yes 2. no 3. don’t know 15. clinical trial...

CLINICAL TRIAL RISK AND PERFORMANCE

MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019PHILADELPHIA, PA USA

Vendor Oversight TrackDay 2

05Sep2019

Liz Wool, RN, BSN, CCRA, CMT

MCC AmbassadorWool Consulting Group, Inc.Wool Training Institute, A Division of Wool Consulting Group, Inc.

Nashville, TN USA

liz@woolcg.com*©Copyright -Slides used with Permission*

CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Agenda

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8:30-8:50 AM WELCOME:

• Day 1 Re-Cap

• MCC Vendor Oversight Metrics Solutions

8:50-9:30 AM PRESENTATION: Vendor Oversight

9:30-10:30 AM PANEL: Utilizing Metrics to Manage Vendor Risk and Performance

10:30-11:00 AM BREAK

11:00-12:00 PM EXERCISE: Vendor Oversight Part 2

12:00-1:00 PM LUNCH

1:00-2:30 PM EXERCISE: Reconvene – Group Interactive Exercise

CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Polling Question

What did you learn yesterday that you want to take back to

your organization? Statement here

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Re-CAP of Day 1

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

MCC

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA 6

Vendor Oversight

Oversight & Quality

Vendor Oversight

Relationship & Financial

Best Practice Community

CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Built Upon..

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Core Laboratory

Metrics Suite

• Data Management, Biostatistics & Medical Writing Metrics

• eCOA Metrics

• Imaging Metrics

• Cardiopulmonary Metrics: ECG, Ambulatory BP Monitoring, Spirometry

• Trial Master File (TMF) Metrics

• White Paper: Vendor Oversight Metric Updates - Overall Approach

CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Built Upon..

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• Vendor Relationship Metrics

o Implementation Guide

oMetrics Workbook

oRecorded webinar

• Vendor Oversight Timeliness Metrics

oWhite Paper: Vendor Oversight Timeliness Metrics

oMetrics workbook

oRecorded webinar

Relationship & Timeliness

Metrics Suite

CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

In 2019..

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Vendor Oversight

Quality & Financial

• White Paper: Vendor Oversight Critical Success Factors

• Vendor Oversight Quality Metrics

oVendor Oversight Quality Toolkit: Implementation Guide

oMetric workbook

oRecorded webinar

oMetric calculator tool with webinar

• Vendor Financial Oversight Metrics

o Working Group Meeting Sept 11, 2019

CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

In 2019..

10

Review

Update

• White Paper: Vendor Oversight Relationship Metrics

• Central Laboratory Toolkit

• Imaging Vendor Metrics

oMeeting July 2019

CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA 11

CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA 12

CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Polling Question #1

What type of metrics do you use in Vendor oversight? Select

those that apply

1. None at this time

2. Timeliness

3. Quality

4. Cycle time

5. Relationship

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Polling Question #2

Rank importance of the following topics for vendor management

1. Determining risks with vendors

2. Metrics for subcontractor performance

3. Relationship metrics

4. Change orders, expanded/new SOW for clinical trial

5. Tailored oversight to the type of service, duty/function performed

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Polling Question #3

Did the Philadelphia Eagles do the right thing in letting go of Nick Foles (quarterback and 2 years ago led the team to SuperBowlVictory!)

1. Yes

2. No

3. Don’t know

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Vendor

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Vendor

CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

CRITICAL TO QUALITY ANALYSIS, CONTROLS, ONGOING MONITORING OF PERFOMANCE

CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Human Subject ProtectionIP Safety Profile

Critical or Non-Critical Vendor

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Critical or Non-Critical Vendor

Computerized (Electronic) Systems

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Critical or

Non-Critical Vendor

S

O

L

E

S

O

U

R

C

E

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Critical or Non-Critical Vendor

• Trial management

• Monitoring

• Medical Monitoring

• Clinical data management

• Statistics

• Statistical programming

• Quality assurance auditing

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Critical or

Non-Critical Vendor

• Core laboratories

• Biomarker analysis laboratory

• Safety/Pharmacoviglance

• Protocol Deviation Review, Management

• Investigator Meeting Planner

• Training Department

• Trial Master File

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

VENDOR

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Vendor Oversight Practices

• Assignments: Expert – Mastery level of

competency

• Internal capabilities assessment: Get budget!

o Right resources

o Right assignments

o Right time

o FTE or consultant?

• Quality standards

• Review of Work Product: systems, procedures,

processes, instructions, training –and document!

• Effectiveness checks of oversight

• PDCA!

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Vendor Sub-Contractor Oversight Practices

S

P

O

N

S

O

RCentral Lab

C

R

O

Specialty

Lab

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Foundational Metrics

• Contractual obligations

• Compliance/Law obligations

• BEYOND the SOW

o Process mapping

o Sequencing of work product

deliverables

o Interdependencies

o Data sources

o Critical to data integrity and reliability of

trial results activities (e.g., User System

Requirements, User Acceptance

Testing)

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Foundational Metrics

• Time: Delivered on the date expected

• Cycle-time: Time start to time completed

• Quality: not done correctly, completely,

accurately, number of times sent back to

‘fix’, per the established standards, does

not meet agreements, standards for

work/assignment

• Relationship: Healthy, trusting, effective

decisions and communication

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Foundational Metrics

Timeliness Cycle Time Quality Relationship

SUSARs reporting Contracts – all

Vendors for the study

Number of times

monitoring reports

returned for addition,

correction

Adequate resources

to support the project

ePRO User System

Requirements

Laboratory tests

reported within

agreed upon

turnaround time

Number of times

database unlocked

during the study

Decision – making

responsibilities and

pathways defined,

effective

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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA 29