Cambridge Healthtech Institute’s 3rd Annual

Managing Outsourced Clinical Trials  

Measuring Performance & Forming Quality Partnerships
January 25-26, 2017 | Hyatt Regency Miami | Miami, FL

As more clinical trial activities are outsourced to contract research organizations (CROs) and other third party vendors, sponsors and their partners must learn to form effective and quality partnerships. Effective management of outsourced clinical trials requires realistic and explicit expectations from each partner in the outsourcing relationship as well as the ability to measure partnership and project performance and quality. Cambridge Healthtech Institute’s “Managing Outsourced Clinical Trials” conference features case studies and lessons learned from sponsors and CROs on how to measure vendor quality and performance, as well as optimize the outsourcing partnership to achieve more efficient clinical trials.

Final Agenda

Wednesday, January 25

12:05 pm Bridging Luncheon Presentation: Introducing DrugDev Spark™ - Technology to Transform Clinical Operations

Brett_KlegerBrett Kleger, Chief Commercial Officer, DrugDev

DrugDev Spark™ is revolutionary clinical technology that brings all administrative solutions sponsors, CROs and sites need to run a trial together into one unified solution suite with a single sign on. Featuring solutions from site selection and activation, to payments, training and eConsent, all tied together with the DrugDev Golden Number DrugDev Spark is primed to transform the way global clinical trials are run. Join us for lunch and an exclusive preview at SCOPE!

12:50 Coffee and Dessert in the Exhibit Hall

1:30 Plenary Keynotes

3:00 Refreshment Break in the Exhibit Hall (Last Chance for Viewing)


4:00 Chairperson’s Remarks

Christopher Rull, Vice President, Head of Business Development & Account Management, UBC

4:05 Sourcing Need to Provider Selection: Part II: A Strategy for Translating Contracts into an Effective Partnership

Marija Nikolic, Associate Director, Development Operations, Contracts & Outsourcing, Vendor Management, Astellas Pharma Global Development, Inc.

You’ve navigated the stormy sea of provider evaluation and selection and the contract is signed. What next? How do you carry the momentum forward into the post contract phase to evolve the relationship from sponsor-provider to sponsor-partner? Which providers should be considered for true partnership? What makes a partnership successful? This talk will provide proposals for how to make the evolution from provider to partner. Suggestions for what a good partnership can look like and which provider categories are most likely to benefit from a true partnership.

4:30 How a Clinical Team Avoided $420k in CRO Change Orders

Morrison_RickRick Morrison, CEO, Comprehend

Learn how a leading clinical development team revolutionized their relationships with their CROs. Understand the best practices they put in place to continuously manage study quality and achieve milestones on-time and on-budget across their portfolio of trials. This session will outline the 5 best practice steps they took to avoid delays and costly overruns in areas such as: enrollment, site productivity, medical monitoring, and data management.

4:55 Co-Presentation: Exploring the Linkages of End-to-End Business Process with Operational Performance for Successful Partnerships in Clinical Development

Charlotte_FrenchCharlotte French, Senior Director, Global Head, Contracting & Outsourcing, EMD Serono

Christopher Rull, Vice President, Head of Business Development & Account Management, UBC

This session will provide the participants with an overview of the End-to-End Business Processes required to support the successful Operational Delivery of clinical trials. In today’s economic and competitive climate there is an increased need for service providers to support their Partners with the necessary financial transparency throughout a project lifecycle, from initial budgeting to provision of forecasting data to support the Financial Operating Plan process. We will share best practices on how this data can be utilized by Project Leadership at both the sponsor and service provider to manage resource assignment for operational delivery of the associated studies, monitor performance and provide reliable forecast data utilizing activity based methodologies.


5:45 Reception hosted by Exostar

Thursday, January 26

7:15 am Registration

7:30 Co-Breakfast Presentation: The Inspiring Hope Ideathon: Solutioning the Clinical Trial Awareness Gap

Phillips_ChristineChristine Phillips, Senior Director, Site & Patient Access, INC Research

Angela_RadcliffeAngela Radcliffe, Executive Vice President, Senior Leadership, FCBVIO

To advance society’s ability to respond to future healthcare challenges and advance medical innovation we must increase awareness of clinical research and study participation. Clinical research is vital to the development of new drugs and treatments but is dependent on patient participation. The “Inspiring Hope Ideathon” was the first initiative of its kind designed to generate new and unique ideas. The participation and results were groundbreaking and will be shared here!


8:35 Chairperson’s Remarks

Rick Morrison, CEO, Comprehend

8:40 Like Mars & Venus...Only Worse: Exploration of Common Peeves in the Sponsor/Service Provider Relationships and Potential Ways to Mitigate

Chris_ChanChris Chan, Senior Director, R&D Finance, FibroGen, Inc.

The sponsor/vendor relationship has been an ongoing issue and challenge throughout the ongoing history of outsourced drug development activities. This presentation will identify some of these issues and discuss ways to alleviate.

9:05 So I Contracted with My Vendor…Now What?!

Tenley_KoepnickTenley Koepnick, Senior Director, Clinical Operations, Edwards Lifesciences

The development of an ongoing, iterative, and collaborative vendor oversight dialog is a natural and needed progression following the outsourcing and contract execution process. This session will explore the often under-valued, yet GCP-required need for a Sponsor to maintain proper vendor oversight. Even more so, we will explore practical techniques that a Sponsor or Vendor could implement to drive the quality of vendor deliverables throughout the contract duration. Focus will be on building positive Sponsor-Vendor relationships with examples of what has worked (…and what has not worked).

9:30 Evaluating Sponsor-Service Provider Relationships and Performance

Elspeth_CarnanElspeth Carnan, Global Head, R&D Operational Excellence, Sunovion Pharmaceuticals

9:55 A Data-Driven Approach to More Effective Studies Strategies

G_Paul_EvansG. Paul Evans, Ph.D., Corporate Vice President, Global Site Solutions, PAREXEL International

A discussion on a data-driven method for applying actionable intelligence and predictive analytics to produce more effective study strategies. Transforming data into knowledge can be applied in various arenas ranging from protocol design, country and site selection, site access, patient enrollment, quality, and satisfaction. The data can ultimately improve feasibility, drive better enrollment solutions, and mitigate risk.

10:20 Coffee Break


10:35 Chairperson’s Remarks

John Boland, Vice President, Product Development, Atlantic Research Group, Inc.

10:40 CO-PRESENTATION: A Model Methodology for Building a Win-Win Partnership between a Sponsor and CRO

Mark_MannMark Mann, Head, Clinical Outsourcing and Contracts, Upsher-Smith Laboratories

Julie_RossJulie Ross, President, Advanced Clinical

The model methodology for building a win-win partnership between a Sponsor and CRO starts with trust and vulnerability. You need to break down barriers and build behaviors and actions which will determine desired outcomes. Each organization not only needs to track performance and deliverables, they need to track the “right stuff”, because true success is measured beyond contract deliverables.

11:20 Sponsored Presentation (Opportunity Available)

11:35 A Method for Establishing a Set of Sponsor & Vendor Oversight Metrics

Linda_SullivanLinda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC

The model followed by today’s sponsors is to outsource most, if not all, functional area study tasks to vendors. Sponsor resources no longer do; they manage. This session provides the steps for establishing effective metrics for managing oversight; metrics that matter and that report results at the appropriate oversight level. We will outline the use of a Clinical Trial Process Map, Critical Success Factors, Key Performance Questions and the proper application of metric visualizations to communicate result trends when developing and reporting oversight metrics.

12:00 pm PANEL DISCUSSION: Determining a Good Sponsor/Vendor Partnership

Rene_StephensRéne Stephens, Executive Director, Global Head, Global Contracts & Outsourcing Management (GCOM), Astellas

Tenley_KoepnickTenley Koepnick, Senior Director, Clinical Operations, Edwards Lifesciences

Linda_SullivanLinda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC

Chris_ChanChris Chan, Senior Director, R&D Finance, FibroGen, Inc.

Andy_TownshendAndrew Townshend, Senior Vice President, Alliance Development, INC Research

Charlotte_FrenchCharlotte French, Senior Director, Global Head, Contracting & Outsourcing, EMD Serono

Christopher Rull, Vice President, Head of Business Development & Account Management, UBC

Luke Van Hengel, Corporate Vice President, Business Operations, PAREXEL International

The panel will discuss each function’s role and perspective on how they measure and evaluate a good sponsor-vendor relationship and how the group factors each function’s perspective to make decisions that affect the sponsor-vendor relationship.

12:50 Closing Remarks

12:55 SCOPE 2017 Conference Adjourns (see you in Orlando for 2018!)

2017 SCOPE Conference at a Glance

SCOPE 2016 Wrap-Up

The 7th Annual SCOPE Summit, held February 23-25, 2016 in Miami, Florida, had record attendance with more than 1,150 industry leaders joining 3 days of in-depth discussions covering important issues in clinical trial planning and management. As SCOPE grew in attendance by 30% over last year, the 2016 program offered 12 distinct conference tracks, 2 symposia, 3 short courses, and 4 plenary keynote sessions, focused on 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, Outsourcing, Forecasting, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Statistics and Biomarker-Driven Trials.

For Further Information

For questions or suggestions about the meeting, please contact:

Lee Yuan
Conference Producer
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5404

For partnering and sponsorship information, please contact:

Ilana Quigley
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457

For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456