This document summarizes a webinar about the importance of site relationships in clinical research. It discusses why site relationships matter for sites, sponsors, and clinical research organizations. Building strong relationships requires effort due to competing priorities and a remote working environment. Suggestions are provided for improving relationships, such as remote engagement, team building, mentoring junior staff, and celebrating successes. Fostering site relationships benefits all parties and helps ensure patient safety and trial success.

1. Site Relationships:
Why They Matter And How To
Foster Them
Kelly White, Project Manager, Stiris Research
PRESENTED BY: AND

2. Webinar Housekeeping
 Slides and recording will be distributed to all registrants
 Use mic & speakers or call in
 Submit questions via GoToWebinar portal

3. Kelly White
Project Manager, Stiris Research
 Trauma and Critical Care nurse
 18 years in clinical research
 CRA
 Regional Clinical Operations Manager
 Project Manager
 Expertise in
 Personalized Health Care
 Risk Based Monitoring

4. Agenda
 Why Do Site Relationships Matter?
 Why Is It Difficult At Times?
 What Can We Do To Improve Our Relationships?
 Site Relationships 101 – Key Takeaways
 Q&A

5. Site Relationships:
Why They Matter And How
To Foster Them

6. Site Relationships
CRITICALLY ESSENTIAL
But often underestimated!
 For our partners
 For our business
 For our sites
 For our patients

7. Why Do Site Relationships Matter?
 Site Perspective: trust, comfort and reliability
 Sponsor or Partner Perspective: a positive and consistent impression in the field
 Clinical Research Organization: often the ‘pivot point’ whereby the Site and the Sponsor
come together; ultimately to the patient benefit

8. The Bottom Line
We are all people…
Patients Sponsors Sites CROs
People tend to thrive and succeed under circumstances of trust and familiarity

9. Are We All Pulling It Off?
For the most part we do and we intend to, but...
Messaging from Partners:
 “Site Relationships are very important to us”
 “We want you to take this project on and help us rescue our site relationships”
Leads us to believe there is room for improvement

10. Why Is This Difficult At Times?
What Are The Various Barriers?

11. We All Have A Gazillion Things To Do

12. …And Some Seriously Important, Non-
Negotiable Responsibilities

13. In An Increasingly ‘Remote’ World
 Relationships require a bit more thought and ingenuity than in the past
 “On Site” CRA visits are not as frequent and often extremely busy
 PM responsibilities greatly reduce opportunities for “On Site” time
 Key Global Roles have the least opportunity for local F2F interaction
 Investigator Meetings are more frequently remote meetings

14. Technology
 Site relationships require “old fashioned” thinking

15. Industry Explosion
Science is moving at lightening speed
 Many new, talented members have joined the industry: PMs, Scientists, CRAs
 In 2015 over 10,000 CRA positions open in the USA alone
 They know their regulations, GCPs, and core competencies, but…
 Have we afforded the time to share, mentor, and demonstrate the art of the Site Relationship?
 Have we fostered the chance for everyone to gain experience and comfort with building the Site
Relationship?
 Have we overlooked these aspects?

16. What Can We Do?
How Will It Help?

17. Solutions And Suggestions
Start with your own team base
 Do they know anything about each other?
 Regular calls to touch base
Remote team calls
 Offer pictorial introductions
 Share something about yourselves
 Use comical (but appropriate) examples within your training sessions

18. Kelly White
 1991-2001: Trauma/ICU Nurse
 1995-1999: Medical Advisor to Local
Film and Television Industry
 2000-2004: Industry Contract CRA
Work
 2004-2014: Roche Canada as a CRA
and Resourcing for Oncology in
Canada
 2014-2016: Regional Clinical
Operations Manager for the CRA
Group in Canada; Initial Team Build
for the Quintiles-Roche Partnership
Model
 2016-Present: Project Manager at a
Dog Friendly Company called Stiris

19. Involve Key Global Roles
 Seize opportunities to have them interact with sites
 Give them a name and personal relationship
 Key Global Roles
 Global Project Managers
 Science Team
 Data Management
 Biostatistics
 Medical Monitor
 Lab Manager

20. Lead By Example
 Attend a site visit with your team members
 Partner a senior-level mentor with a more junior team member
 Extend beyond the CRA role
 PMs and other team members need mentoring too!
 Assess before the visit: Are there areas where the team member has experienced difficultly?
 Repeatedly turned down for PI meeting
 Site staff possibly being too busy
 Review past situations and actions
 Assist to re-formulate a new approach

21. Remote Strategies to Foster your Site
Relationship
 Pictorial introductions
 Invite the site team to prepare and share if they are comfortable
 Ask site members to present topics as well!
 Help your team learn to plan
 Work around clinic times for your calls
 Suggest that the site choose from 3 or 4 dates and times rather than suggesting only 1 opportunity
 Make mention of successes and celebrate them
 Plan ahead for deadlines; outline tasks and timelines simply and easily
 Always have a plan B

22. Teamwork
 Ensure your sites know you are on the same team
What can we sort out together?

23. What are the Results?
 Sites
 Tend to contact you more often
 Less chance of misunderstandings, mishandling of the protocol, or surprise issues
 Have confidence with the study and this translates into their interactions with their patients
 Patients
 Likely feel secure and fully informed when interacting with the site staff

24. What are the Results?
 Sponsors and Partners
 Benefit from the great relationships that all team members have with a site
 Last minute changes or queries seem to run more smoothly
 CRO
 Livelihood depends heavily on this relationship
 Afforded the opportunity to help bring treatments to patients

25. Key Takeaways
Site Relationships 101

26. Site Relationships 101
This involves all levels of the team
and all should be treated as equally important
from the Global Science Leader to the person that books your visits
and greets you at the clinic front desk!

27. Site Relationships 101
Key Takeaways
 Ones level of education, years of experience, or GCP exam score does not translate to their
level of comfort or ability to foster effective site relationships
 Please do not assume
 Lead by example in a non intimidating fashion
 Offer remote suggestions and strategies
 Build their confidence and be available

28. Site Relationships 101
 Core Competencies, Scientific Knowledge, Safety Vigilance, Interpretation and Application of
GCP and Regulations are responsibilities that cannot be diminished at anytime
 Relationships that you build are the key to effectively driving these clinical trials
 Measuring Stick
 The day that a prospective new partner does not feel the need to remind us that site relationships
are important. It will instead be an unspoken given.

29. Thank You
Kelly White
Project Manager, Stiris Research
info@stirisresearch.com
Q&A
Melanie Ciotti
Marketing Strategist, SDC
data@sdcclinical.com