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Whitepaper Downloads

What is the Best Way for Manufacturers and Physicians to Apply Sunscreen to Avoid Being Burned by the Final Sunshine Act Regulations?

Author: Abraham Gitterman, Associate, Arnold & Porter, LLP

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Speaker Articles

Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate Biopharma's Approach, Part I.

Co-Authors:
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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Interviews

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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Podcasts

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.

Débora is speaking at the Clinical Trial Forecasting, Budgeting and Contracting conference, part of SCOPE Summit, taking place February 12-15, 2018 in Orlando, FL. For more details, please visit: www.SCOPESummit.com/Forecasting-Budgeting/

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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.

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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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Postmarketing Regulatory Environment in Europe and the Role of Observational Studies in Drug Risk-Benefit Studies

Vera Ehrenstein, MPH, DSc, Associate Professor, Department of Clinical Epidemiology, Institute of Clinical Medicine, Aarhus University

Amid Zand Interview Dr. Vera Ehrenstein of Aarhus University (Denmark) on December 27, 2014. Dr. Ehrenstein will be speaking at the SCOPE Summit in Orlando, FL in a track titled managing late stage research, observational studies and registries. Her talk will focus on collaborating with regulatory bodies such as the EMA on risk-minimization studies.

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Effective Patient Engagement and Education for Clinical Trials Recruitment and Retention Transcript

Nariman Nasser, Digital Strategist, Genentech

Amid Zand Interview Ms. Nariman Nasser of Genentech, on December 23, 2014. Nariman will be speaking at the SCOPE Summit in Orlando, FL in a track titled managing late stage research, observational studies and registries. Her talk will focus on digital strategies that makes observational studies more accessible and better aligned with patients lives.

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Managing Drug Safety Challenges from Clinical Trials to Post Marketing Stages

Sundos Hamza, M.D., Senior Vice President, Drug Safety Risk Management, InterMune

Amid Zand Interview Dr. Sundos Hamza of InterMune on December 12, 2014. In this interview Dr. Hamza speaks about the importance of effective global drug safety risk minimization strategies in clinical and post marketing phases of drug development.

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In Memory of Gerald “Jerry” Matczak
Matczak Jerry

Gerald “Jerry” Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

– Cambridge Healthtech Institute (CHI)