Speaker Articles & White Papers

Medical Device Reimbursement Strategy: How to Plan for Successful Market Commercialization
Author: Edward Black, Director of Global Reimbursement Strategy, NAMSA Read White Paper

Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate Biopharma's Approach, Part I.
David Knepper, Head, Continuous Improvement, Forest Laboratories
Andy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.

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Technology Considerations to Enable the Risk-Based Monitoring Methodology
Contributing Author: Shelly Barnes, Senior Project Manager, Global Clinical Solution Center – Strategy and Innovation, Sanofi
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January 20, 2020 Clinical Research News  Waving a Magic Wand To Fix Clinical Trial Challenges - an interview with Jane Myles, Founder and Director, JemTech

January 10, 2020 Clinical Research News
Transformational Change To The Supply Chain an interview with Matthew Moyer, MS, MBA, PMP, Director, Clinical Supply Technology, Global Clinical Supply, Merck & Co., Inc.

December 10, 2019 Clinical Research News
Real World Evidence And European Regulations an interview with Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific Corporation

February 13, 2019 Clinical Research News
Clinical Trials In The Age Of Data Marina Filshtinsky, Executive Director of Conferences at Cambridge Healthtech Institute

February 2019 Yprime Blog Post
SCOPE 2019 Summary – Beyond the Pilot, Moving Towards Implementation Donna Mongiello, RN, BSN, Vice President Strategic Solutions, YPrime

February 12, 2019 Clinical Research News
IRT Developers, Engineers See The Patient Beneath The Data an interview with Andrew Rohrbaugh, Director of Client Delivery at Cenduit

February 7, 2019 Clinical Research News
Doing More With Less: The Road To Success For Clinical Trials an interview with Rosie Filling, Vice President of Clinical Development Operations at Endo

February 5, 2019 Clinical Research News
The Informed Patient: How Biosample Management Is Evolving For Consent an interview with Caoimhe Vallely-Gilroy, head, Clinical trial biosample management and informed consent at Merck KGaA

February 1, 2019 Clinical Research News
How Real World Data Changes Clinical Trials, And What That Means For Patients an interview with Martin Marciniak, US Medical Affairs Vice President, leading the Customer Engagement Value Evidence and Outcomes Team at GlaxoSmithKline

January 31, 2019 Clinical Research News
Real Risk, Real Quality: Risk-Based Monitoring In Clinical Trials Today

January 28, 2019 Clinical Research News
A Realist Looks At AI In Clinical Trials an interview with Ronald Dorenbos, Associate Director Materials & Innovation, digital strategies group for neuroscience at Takeda

January 11, 2019 Clinical Informatics News
The Future Of Real World Data In Clinical Trials an interview with Cathy Critchlow, Vice president and head of the Center for Observational Research, Amgen

January 9, 2019 Clinical Informatics News
Starting Line: How To Begin Getting Patient Input Into Clinical Trial Design an interview with Beth Zaharoff, Director of patient-focused clinical trial engagement at TESARO

How Real World Data Changes Clinical Trials, And What That Means For Patients
With: Martin Marciniak, PhD, Vice President, US Medical Affairs, Customer Engagement, Value, Evidence & Outcomes, GSK
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Real Risk, Real Quality: Risk-Based Monitoring In Clinical Trials Today

With: Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
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A Realist Looks at AI In Clinical Trials
With: Ronald Dorenbos, PhD, Associate Director, Materials and Innovation, Takeda Pharmaceuticals
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Are We Ready for AI In Clinical Trials?

With: Francis Kendall, Director, Biostatistics & Programming, Cytel, Inc.
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Preparing CRAs to be Site Recruitment Managers: The Pros, the Cons and The Process
With: Beth Harper, President, Consultant, CPP, Inc.
Nikki Christison, President, Consultant, Clinical Resolutions, Inc.
Gretchen Goller, Senior Director, Patient Access and Retention Services, PRA International

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Kelly Zou: Mathematics, Statistics, Data Science, and Dreams
Kelly Zou, Ph.D., PStat®, Senior Director and Analytic Science Lead, Real World Data & Analytics (RWDnA), Global Health & Value (GH&V), Pfizer, Inc.
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Kelly Zou: Meet Inspirational Women in Statistics & Data Science
Kelly Zou, Ph.D., PStat®, Senior Director and Analytic Science Lead, Real World Data & Analytics (RWDnA), Global Health & Value (GH&V), Pfizer, Inc.
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Clinical Trial Outsourcing and The Need for Collaboration and Performance Metrics

Thomas P. Lawler III, MBA, PMP, Founder & Managing Partner, BaywynSolutions, LLC

Tom Lawler, Founder & Managing Partner, BaywynSolutions spoke to CHI to discuss the role of teamwork in outsourcing relationships for clinical trials and some of the tangible challenges, delays, and errors that can come from teams lacking a collaborative framework. He also discusses some metrics groups can use to measure their success in their outsourced relationships.

Tom is speaking at Outsourcing for Clinical Trials, taking place April 25-26, 2017 in Boston as part of the Clinical Trial Innovation Summit. For details, visit:www.ClinicalTrialSummit.com/Clinical-Outsourcing/

Outsourcing in Clinical Trials: Lessons Learned from a Pharma and CRO Perspective

Vatche Kalfayan, Senior Director, Clinical Operations, Pfizer

Vatche Kalfayan, Senior Director, Clinical Operations, Pfizer spoke to CHI to discuss the lessons learned about outsourcing for clinical trials from his experience working in pharma and founding a CRO. He discusses the biggest challenges clinical trial professionals are facing in their outsourcing models and strategies, as well as some examples of how the field is changing and what he’s working on to drive some of that change.

For details, visit:www.ClinicalTrialSummit.com/Clinical-Outsourcing/

Clinical Trial Contracting Challenges: Streamlining CTA Negotiations Beyond Legal Language

Débora Araujo, Associate Director, Site Budgets and Payments (US Group Head), Boehringer Ingelheim Pharmaceuticals, Inc.

Débora Araujo of Boehringer Ingelheim spoke to CHI to discuss her expertise in clinical trial agreements and some of the daily challenges she faces in negotiations and contracts. She specifically discusses some of the key barriers within and beyond the legal language of CTAs and also shares highlights from her forthcoming book, The Four Villains of Clinical Trial Agreement Delays and How to Defeat Them.

Clinical Trials: Patient Centricity and Wearables

Jaydev Thakkar, Clinical Trial Design and Management, Global IS Service Owner, Director Information Systems, Amgen
Jaydev Thakkar of Amgen speaks to CHI on November 1st, 2016. Dr. Thakkar will be speaking during the Clinical Technology and Innovation conference at the SCOPE Summit, January 24-26, 2017 in Miami, FL.

Topics include patient engagement from a data management perspective, using wearables to lower patient burden and tapping into novel endpoints.

Managing Precision Medicine Clinical Trials

Brenda Yanak, Ph.D., Director, Precision Medicine Leader, Clinical Innovation, Pfizer
Brenda Yanak of Pfizer speaks to CHI on Oct 31, 2016. Dr. Yanak will be speaking during the Managing Precision Medicine Trials symposium at the SCOPE Summit, January 24-26, 2017 in Miami, FL.

Topics include the Transcelerate consortium, consent management and the importance of bio-banking in precision medicine.

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From the Producers of:

From the Producers of SCOPE