Managing Outsourced Clinical Trials

As more clinical trial activities are outsourced to contract research organizations (CROs), sponsors must learn to effectively manage their in-house activities in addition to the needs of their CRO partners. Effective management of outsourced clinical trials requires realistic and explicit expectations from each partner in the outsourcing relationship. Cambridge Healthtech Institute’s “Managing Outsourced Clinical Trials” conference features case studies and lessons learned from sponsors and CROs on how to optimize the outsourcing partnership to achieve more efficient clinical trials.

Arrive early and attend Part 1: Clinical Trial Forecasting & Budgeting
Keynotes | Monday Short Courses | Speaker Biographies

Wednesday, February 24 - Thursday, February 25



CLN Best Practices

Plenary Keynote Chairperson’s Opening Remarks & Clinical Informatics News Best Practices Awards

Allison Proffitt, Editorial Director, Bio-IT World & Clinical Informatics News

Innovation, Technology and the Hype Cycle: What Is Real and Adaptable and What Is Not?

Craig Lipset, Head, Clinical Innovation, Pfizer

Adoption Of Technology Solutions In Clinical Trials: Are We Ready?

Margaretta Nyilas, M.D., Senior Vice President, Clinical & Business Operations, OTSUKA Pharmaceutical Development & Commercialization, Inc.

For more details on the Tuesday Opening Plenary Keynote and Wednesday Afternoon Plenary Keynote click here.


Too Much to Ask For?

Thomas P. Lawler III, MBA, PMP, Project & Alliance Management, Ardea Biosciences, A member of the AstraZeneca Group

Co-Presentation: Infiltrating the Partnership Mentality

Heather Zigmund, PharmD, Senior Director and Head of Alliance Management, MedImmune

Michael Williamson, Associate Director, Outsourcing and Contracts Management, UCB Biosciences

PANEL: Breaking Down Boundaries on How Sponsors and CROs Think About Partnering and Outsourcing

Moderator: Thomas P. Lawler III, MBA, PMP, Project & Alliance Management, Ardea Biosciences, A member of the AstraZeneca Group


Elizabeth Shewell, Senior Director, Outsourcing, Incyte

Additional Panelists to be Announced


View from the Rareified Air: Case Studies of Effective Outsourcing Partnerships in the Rare and Ultra-Rare Space

Mark J. Milberg, Associate Director, Clinical Procurement and Outsourcing, Ultragenyx Pharmaceutical Inc.

Case Study: FibroGen perspective on outsourcing in China

Thomas Guntly, Director, Clinical Development, FibroGen, Inc.

Understanding and Applying the Right Outsourcing Strategies to Achieve More Efficient Clinical Trials

Co-Presentation: Outsourcing Strategies & Partnership Models with CROs: Determining the Right Outsourcing Strategy for Small & Large sponsors

Maria Makarovskaya, Director, Strategic Sourcing, Infinity Pharmaceuticals, Inc.

Anja Leo, Head of Vendor and Quality Management, Global Clinical Application Support, Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany

Working with Your CRO to Improve Activation Performance

Jessica Ibbitson, Associate Director, Clinical Site Services, Vertex Pharmaceuticals

Talk Title to be Announced

Ian Wyglendowski, Director, Strategic Partnering, UCB Biosciences, Inc.

Arrive early and attend Part 1: Clinical Trial Forecasting & Budgeting
Keynotes | Monday Short Courses | Speaker Biographies


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SCOPE 2015 Wrap-Up

Held February 24-26, 2015, in Orlando, Florida, the 6th Annual SCOPE Summit gathered more than 900 industry leaders, an attendance increase of 30% from 2014, for three stimulating days of in-depth discussions covering important issues in clinical trial planning and management. With 12 different conference tracks, a Clinical Informatics News Best Practices Awards and three plenary keynote sessions, SCOPE offered advances and innovative solutions in all aspects of clinical trial management and operations, including Data Integration, Feasibility, Site Selection and Management, Patient Engagement, Recruitment and Retention, Mobile Tech, Project Management, Forecasting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, and Pharmacovigilance. The impressive executive audience at SCOPE came together for invaluable networking opportunities with more than 70% of the attendees titled as Executives from leading Pharma (24%), CRO (31%), and Biotech companies (20%). Industry leaders and key decision makers representing 13 different countries and more than 360 unique organizations shared case studies, collaborated on best practices and provided unique perspectives on poignant issues that the field currently faces.

For Further Information

For questions or suggestions about the meeting, please contact:

Lee Yuan
Associate Conference Producer
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5404
E: lyuan@healthtech.com

For partnering and sponsorship information, please contact:

Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457
E: iquigley@healthtech.com

For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456
E: rhandy@healthtech.com

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Preliminary Agenda Available!

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