Upload
others
View
1
Download
0
Embed Size (px)
Citation preview
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*
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
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
3
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT
SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Re-CAP of Day 1
4
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT
SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
MCC
5
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..
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
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT
SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
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
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT
SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
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
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
13
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
14
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
15
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT
SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Vendor
16
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
18
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT
SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Critical or Non-Critical Vendor
Computerized (Electronic) Systems
19
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
20
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
21
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
22
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT
SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
VENDOR
23
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!
24
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
25
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)
26
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
27
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
28
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT
SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA 29