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Agenda

Industry Models for Implementation, Streamlined Data Processes and Change Management to Enable eSource Adoption

May 2-3, 2017
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE Tuesday, May 2, 2017

1:00

Conference Registration

1:45

Chairman’s Welcome and Opening Remarks

Gregory A. Jones
Clinical R&D and EHR Architecture Strategy
Oracle Health Sciences

2:00

What we are missing in eSource?

Matt Kiernan
Partner
Pharmica Consulting

2:45

IN-CONFERENCE WORKSHOP Your eSource Roadmap to Clinical Trial Optimization

I. Defining eSource

II. Setting Expectations with Internal Stakeholders

III. Implementing eSource

IV. Facilitating Change Management

V. Overcoming Investment Challenges

VI. Human Error Management

Michelle Crouthamel
Digital Platform Leader
GlaxoSmithKline

Dan Milam
Vice President, Global Engagements
Society for Clinical Research Sites (SCRS)

*There will be a 30 minute Networking and Refreshment break at 4:00pm

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Wednesday, May 3, 2017

7:45

Continental Breakfast

8:15

Chairman’s Review of Day One

Gregory A. Jones
Clinical R&D and EHR Architecture Strategy
Oracle Health Sciences

8:30

Keynote Presentation

Go Paperless — The Dawn of eClinical Data and How to Keep Up with Its Evolution

Tom Haag
Global Director, Process & Learning
Novartis

9:15

CASE STUDY
The Future Is Now —
How to Obtain Stakeholder Buy-in and Initiate the Migration to eSource

Jules Mitchel
President
Target Health

10:00

Networking and Refreshment Break

10:30

PANEL
Follow The FDA Lead —
Leverage eSource Data to Streamline Regulatory Submission

MODERATOR:

Lisa Henderson
Editorial Director, Applied Clinical Trials
UBM

PANELISTS:

Jonathan Helfgott
Director of Regulatory Affairs
Stage 2 Innovations

Michael Ibara
Owner, Michael Ibara, LLC and Head of Digital Healthcare
CDISC

Imogene M. Dunn
Senior Vice President, Biometrics and Regulatory Affairs
vTv Therapeutics

12:00

Networking Luncheon

1:15

Clinical Trial Innovation — How to Combine eSource Technology with Site-less CRO

Joe Martinez
CEO
Center Point Clinical Services LLC

2:00

Research Site Perspective I — How eSource Can Enable Next-Gen Clinical Trials

Christine Pierre
President
Society for Clinical Research Sites (SCRS)

2:45

Research Site Perspective II —
Early Successes of eSource Implementation and How to Capitalize on It Today

MODERATOR:

Raymond Nomizu
Co-Founder
CRIO

PANELISTS:

Jeff Stein
President & Site Owner
Stamford Therapeutics Consortium

David Scott
President & Site Owner
Palm Beach Research Center

James E. Greenwald, MD, PhD
Site Owner
Medex Healthcare Research, Inc.

3:30

Networking and Refreshment Break

4:00

The TransCelerate eSource Initiative — Understanding the Past, Present and Future of eSource Data in Clinical Investigations

Jennifer Wulff
Director, Clinical Innovation
Pfizer

5:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE Tuesday, May 2, 2017

1:00

Conference Registration

1:45

Chairman’s Welcome and Opening Remarks

Gregory A. Jones
Clinical R&D and EHR Architecture Strategy
Oracle Health Sciences

2:00

What we are missing in eSource?

Matt Kiernan
Partner
Pharmica Consulting

2:45

IN-CONFERENCE WORKSHOP Your eSource Roadmap to Clinical Trial Optimization

I. Defining eSource

II. Setting Expectations with Internal Stakeholders

III. Implementing eSource

IV. Facilitating Change Management

V. Overcoming Investment Challenges

VI. Human Error Management

Michelle Crouthamel
Digital Platform Leader
GlaxoSmithKline

Dan Milam
Vice President, Global Engagements
Society for Clinical Research Sites (SCRS)

*There will be a 30 minute Networking and Refreshment break at 4:00pm

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Wednesday, May 3, 2017

7:45

Continental Breakfast

8:15

Chairman’s Review of Day One

Gregory A. Jones
Clinical R&D and EHR Architecture Strategy
Oracle Health Sciences

8:30

Keynote Presentation

Go Paperless — The Dawn of eClinical Data and How to Keep Up with Its Evolution

Tom Haag
Global Director, Process & Learning
Novartis

9:15

CASE STUDY
The Future Is Now —
How to Obtain Stakeholder Buy-in and Initiate the Migration to eSource

Jules Mitchel
President
Target Health

10:00

Networking and Refreshment Break

10:30

PANEL
Follow The FDA Lead —
Leverage eSource Data to Streamline Regulatory Submission

MODERATOR:

Lisa Henderson
Editorial Director, Applied Clinical Trials
UBM

PANELISTS:

Jonathan Helfgott
Director of Regulatory Affairs
Stage 2 Innovations

Michael Ibara
Owner, Michael Ibara, LLC and Head of Digital Healthcare
CDISC

Imogene M. Dunn
Senior Vice President, Biometrics and Regulatory Affairs
vTv Therapeutics

12:00

Networking Luncheon

1:15

Clinical Trial Innovation — How to Combine eSource Technology with Site-less CRO

Joe Martinez
CEO
Center Point Clinical Services LLC

2:00

Research Site Perspective I — How eSource Can Enable Next-Gen Clinical Trials

Christine Pierre
President
Society for Clinical Research Sites (SCRS)

2:45

Research Site Perspective II —
Early Successes of eSource Implementation and How to Capitalize on It Today

MODERATOR:

Raymond Nomizu
Co-Founder
CRIO

PANELISTS:

Jeff Stein
President & Site Owner
Stamford Therapeutics Consortium

David Scott
President & Site Owner
Palm Beach Research Center

James E. Greenwald, MD, PhD
Site Owner
Medex Healthcare Research, Inc.

3:30

Networking and Refreshment Break

4:00

The TransCelerate eSource Initiative — Understanding the Past, Present and Future of eSource Data in Clinical Investigations

Jennifer Wulff
Director, Clinical Innovation
Pfizer

5:15

Close of Conference