1. Project Management in Clinical Research
Sanjay Akhani,
Sr. Clinical Project Manager, Quintiles

2. DISCLAIMER
• Although I am employed by Quintiles Research India Pvt. Limited, the
material contained in this presentation has not been sponsored or endorsed
by Quintiles Research India Pvt. Limited. No association of this material with
Quintiles Research India Pvt. Limited, its policies or practices is expressed or
implied.
• The concepts and information herein are freely available from many
sources, and their sharing and dissemination is highly encouraged.
However, please do not use the slides themselves without my permission as
their format and configuration are particularly identified with me. Thanks!
Sanjay Akhani

3. Clinical Research:
Project Management
• What is project management in Clinical Research
• PM tools and techniques applied in Clinical Research
• Project Management Plan for Clinical Research
• CRO and SMO Management
• Optimize patient recruitment
• Working with remote and multicultural teams

4. Cost Quality
Project Management Constraints

5. Timeline
+ US
+++ Asia,
Africa
Cost
+++ US
+ Asia,
Africa
Risk
+ US
+++
Asia, Afric
a
Disclaimer: This is just an example, not based on fact.

6. Project
Management in
Clinical Research

7. Business
case
Define
Objectives
Stake
Holders
Develop
Project
Charter

8. Scope
Management
Budget/
Milestones
Project
Management
Plans
Kick-Off
Meeting

9. Regulatory
And Site
Systems/
Vendors
Communication
Training

10. Project
Performance
Review
Change
Management
Stake
HoldersRisk Audit

11. DB lock and
CSR
Sites Close
out
System and
Finance
Archival &
Lessons
Learnt

13. Responsibilities of Project Manager
• Coordination, Communication, Escalation
oAcross Functional Areas
oAcross Stakeholders
• Team Motivation and Management
• Status Review/Risk Management
• Financial Management
Clinical
Operations
DM
PhV
Regulatory
Bodies &
Sites
Project
Manager
Vendors

14. PM Tools and
Techniques applied in
Clinical Research

15. Project Management
Tools/Techniques
 Project Management Software - MS-Project
 Critical Path Analysis
 Event Driven Analysis
 Patient/Treatment Pathways
 WBS
 Rolling Wave Planning
 Bottom up Estimate
 Alternative Analysis
 Contract and Contract Change Control System
 Variance/Trend Analysis
 Analogous Estimate
 Histogram
 Process analysis/Quality Audits
 Issue/Action item log
 Risk log
 RACI Chart
 Assumption Analysis
 Survey/Interviews
 Project Information System

16. Project Systems
Communication
• E-mail/mobile/telephone/fax/podcast
• Sharepoint/WebEx
Data Reporting/Analysis/Archival
• e-CRF/IVRS/IXRS/Web portal
• Clinical Trial Management System (CTMS)
• e-Dairy/Patient cards
• Electronic File Management System

17. Project Management Plan
in Clinical Research

18. Project Management Plan
• Scope/Budget/Milestones
• Regulatory strategy
• Patient recruitment
• Risk management
• Quality management
• Vendor management
Clinical
Operation
PM

19. Study Milestones
• Project Charter Approval
• Kick-off Meeting
• Final Protocol Ready
• First Site Selection
• Investigator’s Meeting
• First Site Activation
• First Patient In (FPI)
• Last Patient In (LPI)
• Last Patient Out (LPO)
• Database Lock
• Draft Table and Figure Listing
• Draft Clinical Study Report
• Final Clinical Study Report
• Last Site Close out
• Archival of Study Document
• Project closure

20. Country/Site Strategy
Country Strategy
• Regulatory Agency
• Sequential submission (Long start up time)
• Parallel submission (Short start up time)
• Central Ethics Committee/Local/Institutional Ethics Committee
• Contract with Investigators/Institutes
Site Strategy
• Patient pool
• Relationship/past performance

21. CRO and SMO Management

22. Contract Research Organization (CRO)
Management
Selection
Therapeutic experience and geographic presence
Relationship with stake holders
IT infrastructure
Management/KPI
Education/Experience/Training/Attrition of Key CRO staff
Weekly/Monthly status review (Start up, Recruitment, Maintenance and Closeout)
Closeout
• Site closeout
• IP return
• Archival of study
documents

23. Site Management Organization
(SMO) Management
• Relationship with Investigators/Hospitals/Institutes
• Experience/Training of staff
KPI
• Patient recruitment/retention/compliance
• Data entry/Query resolution
• IP accountability

24. Optimize Patient
Recruitment

25. Patient Recruitment
• Recruitment Expectations/Planning/Contingency
• Challenges and Risk
 Potential and Actual Barriers from the Country’s/Site’s/Patient’s
Perspective
• Recruitment Plan
 Country/site identifications/selection
 Recruitment projection/adjustments
 Pre-initiations activities
 Recruitment tools and methods

26. Patient Recruitment:
Methods and Tools
• Site staff training/contacts
• Referral Network/Database search
• Advertisement and other recruitment aids
• Investigator /SC Teleconferences
• Web based study-specific patient recruitment
tools

27. • Patient flyer/brochure
• Informed consent flipchart
• Newspaper /Social media ad
Patient Facing Tools
• Study reference cards
• Mini protocols/Resources CD
• Physician slide deck
Site Facing Tools
• Welcome binder/Thank you card
• Visit reminder card
• Patient drug instruction card
Patient Compliance
An educated patient is more retainable and compliant
Recruitment Toolkit

28. Recruitment Contingency
 Booster visits
 Activate back-up sites/countries
 Implement Escalation Plan for slow/non-enrolling Sites

29. Working with Remote
and
Multicultural Teams

30. Working with Remote and
Multicultural Teams
Challenges
• Time zone difference
• Communication style
• Cultural differences (High to Low context)Cultural differences
• Thinks, Acts and Reacts differently
• Different approach to tasks
• Varying approach on Relationship Building
• Personal space, Social etiquette and Belief
• Different attitude for conflict, disclosure
and negotiation

31. Cultural Differences
Low Context High Context
Work Ethics Task-oriented Relationship-oriented
Work Style Individualistic Team-oriented
Relationship Many, looser, short-
term
Fewer, tighter, long-
term
Decision Making Logical, linear, rule
oriented
Intuitive, Relational
Communication Verbal over non-verbal Non-verbal over verbal
Knowledge Explicit, written, formal Implicit, oral, informal
Sense of Time Present/Future
oriented
Deep respect for past
View of Change Change over tradition Tradition over Change

32. High Context ……….……..…Low Context

33. Solution
• Global culture/processes/technology
• Harmonize learning and development
• RACI matrix
• Links, Sharepoint site, Communicator
• Trust building exercise (time zone, geography and culture)
• Flexi work hour
Working with Remote and
Multicultural Teams