casey orvin, president society for clinical research sites

16 July 2019

Site LandscapeCasey Orvin, President

Society for Clinical Research Sites (SCRS)

Faculty DisclosureIn compliance with ACCME Guidelines, I hereby declare:

I do not have financial or other relationships with the manufacturer(s) of any commercial services(s) discussed in this educational activity.

Cheryl-Ann Hawkins, RN, MHA, Clinical Research Manager, Oncology, Alfred Health (Facilitator)

Tam Nguyen, FRSPH, FAIM, PhD, MBA, Deputy Director of Research, St. Vincent’s Hospital, Melbourne (Facilitator)

Carlos China, MD, Regional Clinical Site Lead, Pfizer

Gina Kennedy, MS, Senior Clinical Operations Manager, Covance

Marian Lieschke, RN, Manager, Parkville Cancer Clinical Trial Unit

Lorena Figueroa, B.Pharm, Country Clinical Operations Leader, Roche

Karen West, Executive Director, Clinical Development, Syneos Health

Kurt Lackovic, PhD, MBA, GAICD, CEO, Cancer Trials Australia

Disclaimer

Survey Supporters & Collaborators • CFS Clinical

• Clinical Leader

• DrugDev

• goBalto

• KMR Group

• Medidata

• Survey Respondents (that’s mostly all us sites!)

Any reference to companies is not an endorsement or statement of their services.

Check with your professional consultants (legal, financial, HR, etc.) to obtain specific information pertaining to your company.

This information is not meant to direct you on how to address any specific issues.

Antitrust–compliance policy adherence. http://myscrs.org/24-revision-v1/policies/antitrust-compliance-policy/

http://myscrs.org/24-revision-v1/policies/antitrust-compliance-policy/

Summit Site Landscape Survey

4%

15%

44%

37%

Type of Site

Academic - 4%

Hospital - 15%

Practice - 44%

Freestanding - 37%

Years as a Site<4 – 10%

5-10 – 15%11-20 – 37%

21+ – 38%

SCRS Summit Survey 2018

How Does Your Site Compare?

Number of Staff

Percentage of Sites


0%

10%

20%

30%

40%

50%

1-3 4-6 7-9 +10

PIs CRCs Sub-Is

SCRS Summit Survey 2104, 2016, 2017, 2018

65%

66%

60%

64%

59%

61%

63%

65%

67%

2014 2016 2017 2018

Operating Cash

Less Than 3 Mos. Operating Cash

Withholding Trends

12% 13% 13%11% 12% 12% 12%

14% 11%

0%

4%

8%

12%

16%

20%

2006 2007 2008 2009 2013 2015 2016 2017 2018

Site Solutions Summit 2007, 2008, 2009 & 2010, 2013, 2016, 2017, 2018 CFS Clinical, DrugDev - 2015, *2016

Site Partnerships and Communications

Feeling the Partnership?

More of a Partner

Less of a Partner No Change

Sponsors 31% 23% 47%

CROs 22% 33% 46%


How Sites Feel Their Partnership Has Changed in the Last 2 Years

New Liaisons and Site Impact Opportunities• Site Identification Manager

• Vice President, SMO Affairs

• Director, Site & Patient Access

• Executive Director, Site and Patient Access

• Manager, Site and Patient Access

• Manager, Site Contracts

• Patient and Investigator Engagement

• Manager, Site Start-Up & Regulatory

• Associate Director, Site Management

• Site Solutions Director

• Vice President, Site and Patient Access

• Associate Director, Site Intelligence

• Vice President, Site Intelligence & Strategic Development

• Head of Site Relationship Management

• Director, Site Intelligence and Activation

• Director, Site Technologies

• Investigator Site Development Lead

• Senior Director, Site Intelligence, Site Centricity Unit Clinical Division

• Vice President, Site Intelligence & Strategic Development

• Associate Director, Site Management

• Senior Director, Site Alliances

• Head of Site and Patient Networks for NA

• Senior Director Site and Patient Networks

• Vice President, Head Site and Patient Networks, Americas

• AND MORE

Communication – The Sites’ View

• One point of contact!

• Improve senior site management engagement on issues.

• More communication. Feels like the site is always reaching out to get

info but the Sponsor/CRO is never there.

• Abide more closely to agreed payment terms.

• Build and MAINTAIN relationships with sites.

• Maintain a communication log so we can see how long it takes

Sponsors/CROs to respond.

• Timely response for questions & queries.

Communication – The Sponsor/CROs’ View

• One or two persons should be main contact.

• Sites should be more proactive when they are unsure about what to do.

• Prompt reply on the CRA/DM queries.

• Not sending out emails for every issue.

• Timely return of phone calls and e-mails.

• Partnership to improve communication both ways!

SCRS Pain Point Survey 17

Number of Contacts at the Sponsor or CRO Per Protocol - Comparing This Year to Last

Increased 44%

Stayed the Same44%

Decreased 12%


Communication With Sites On Protocol Related Issues – Comparing this year to last

0%

20%

40%

60%

Improved

Stayed the Same

Worsened

19%

66%

15%

17%

56%

27%

Sponsor CRO


Are you able to quickly reach a knowledgeable person to get an answer to a protocol-related question?

0% 10% 20% 30% 40% 50%

Always

Often

Sometimes

Rarely

Never

CRO Sponsor SCRS Summit Survey 2018

68% Reported Direct Contact With

Decision Maker To Be Extremely Beneficial

Tam Nguyen, FRSPH, FAIM, PhD, MBA, Deputy Director of Research, St. Vincent’s Hospital, Melbourne (Facilitator)

Lorena Figueroa, B.Pharm, Country Clinical Operations Leader, Roche

Karen West, Executive Director, Clinical Development, Syneos Health

Kurt Lackovic, PhD, MBA, GAICD, CEO, Cancer Trials Australia

Site Partnerships and Communication

Study Startup and Feasibility

Site Activation Investment ~14 Mos.

Clinical Leader May 2016

3.2 Mos. 8 Mos. 2.5 Mos.

Site Selection Pre-Visit - Contract Executed Site Initiation - Activation

Comparison to Oncology in Victoria

Clinical Leader May 2016

3.2 Mos. 8 Mos. 2.5 Mos.

Site Selection Pre-Visit - Contract Executed Site Initiation - Activation

3 Mos. 3.1 Mos.

Site Selection HREC Submission to SIV

Data is presented as medians from over 100 Cancer Trials Australia supported oncology studies, across multiple Victorian hospitals in 2018, total calendar days, no ‘stop clocks’ applied.

Time to Execute Contracts Globally

10.92

9.91

17.23

12.72

15.38

0 2 4 6 8 10 12 14 16 18 20

Contract

Asia Pac EMEA LA NA Global

*10.3 weeksgoBalto 2016, *KMR Group 2016

Site’s Solutions to Enhance Study Start-Up1. Provide more study information during feasibility process

2. Provide financial information during the feasibility process

3. Less time between when site is approved to begin study and site initiation

4. Streamline budget process

5. Standardize contract clauses

6. One system to enter dataSCRS Summit Survey 2016

Not selected for a study?

How often do youhear back about the decision?

Always8%

Often27%

Sometimes31%

Seldom29%

Never5%


Site Qualification Visits

Always 4%

Often 36%

Sometimes 41%

Rarely 18%

Never 2%Do the CRAs have adequate knowledge about the study?


Site Qualification Visits

How does the study knowledge of the CRA compare to last year?


8%

63%

29%

Improved

Same

Worsened

Did I Answer Your Questions?

How often does the CRA follow up with answers to questions raised at the SQV?

SCRS Summit Survey 2018Always - 11%

Often - 47%

Sometimes - 33%

Rarely - 8%

Never - 1%

0%

10%

20%

30%

40%

50%

Finance and Payment Terms

Of all the clinical trial agreements you signed, indicate the most frequent payment terms:

49%

28%

16%

44%39%

10%

Quarterly Monthly Bi-monthly

2016 2017SCRS Summit Survey 2018

What is your preferred payment schedule?77%

10%6% 6%

Monthly I have nopreference

Bi-monthly Quarterly SCRS Summit Survey 2018

When negotiating a quarterly or bi-monthly payment schedule to a monthly payment schedule:

60%

13%

2%

13% 12%

6%

32%

25%28%

9%

Every time Most of the time Half of the time Some of the time Never

How often do you try to negotiate better terms?

How successful are you?


Cheryl-Ann Hawkins, RN, MHA, Clinical Research Manager, Oncology, Alfred Health (Facilitator)

Carlos China, MD, Regional Clinical Site Lead, Pfizer

Gina Kennedy, MS, Senior Clinical Operations Manager, Covance

Marian Lieschke, RN, Manager, Parkville Cancer Clinical Trial Unit

Study Startup, Feasibility, and Finance

Thank You To Our Panelists

Site Landscape SurveyEnsure the Asia-Pac Site Voice is Heard

MySCRS.org/Learning-Campus/Surveys

https://myscrs.org/learning-campus/surveys/

Networking BreaksSponsored by

casey orvin, president society for clinical research sites

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