Site Relationships:Why They Matter And How To Foster ThemKelly White, Project Manager, Stiris Research

PRESENTED BY: AND

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Kelly WhiteProject 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

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

Site Relationships: Why They Matter And How To Foster Them

Site Relationships

CRITICALLY ESSENTIAL

But often underestimated!

For our partners For our business For our sites For our patients

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

The Bottom Line

We are all people…

Patients Sponsors Sites CROs

People tend to thrive and succeed under circumstances of trust and familiarity

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

Why Is This Difficult At Times?What Are The Various

Barriers?

We All Have A Gazillion Things To Do

…And Some Seriously Important, Non-Negotiable Responsibilities

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

Technology

Site relationships require “old fashioned” thinking

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?

What Can We Do?How Will It Help?

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

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

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

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

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

Teamwork

Ensure your sites know you are on the same team

What can we sort out together?

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

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

Key TakeawaysSite Relationships 101

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!

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

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.

Thank YouKelly White

Project Manager, Stiris Researchinfo@stirisresearch.com

Q&A

Melanie CiottiMarketing Strategist, SDC

data@sdcclinical.com