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

[email protected]*©Copyright -Slides used with Permission*

mailto:[email protected]

CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT

SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA

Agenda

2

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



Polling Question

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

your organization? Statement here

3



Re-CAP of Day 1

4



MCC

5


SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA 6

Vendor Oversight

Oversight & Quality

Vendor Oversight

Relationship & Financial

Best Practice Community



Built Upon..

7

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



Built Upon..

8

• 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



In 2019..

9

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



In 2019..

10

Review

Update

• White Paper: Vendor Oversight Relationship Metrics

• Central Laboratory Toolkit

• Imaging Vendor Metrics

oMeeting July 2019



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

13



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

14



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

15



Vendor

16

Vendor



CRITICAL TO QUALITY ANALYSIS, CONTROLS, ONGOING MONITORING OF PERFOMANCE



Human Subject ProtectionIP Safety Profile

Critical or Non-Critical Vendor

18




Computerized (Electronic) Systems

19



Critical or

Non-Critical Vendor

S

O

L

E

S

O

U

R

C

E

20




• Trial management

• Monitoring

• Medical Monitoring

• Clinical data management

• Statistics

• Statistical programming

• Quality assurance auditing

21



Critical or

Non-Critical Vendor

• Core laboratories

• Biomarker analysis laboratory

• Safety/Pharmacoviglance

• Protocol Deviation Review, Management

• Investigator Meeting Planner

• Training Department

• Trial Master File

22



VENDOR

23



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!

24



Vendor Sub-Contractor Oversight Practices

S

P

O

N

S

O

RCentral Lab

C

R

O

Specialty

Lab

25



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)

26




• 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

27




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

28

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

Documents