Perfecting Quality Partnerships for Clinical Trial Success

May 10-11, 2016 | Westin Boston Waterfront Hotel | Boston, MA

Part of CHI's Fifth Annual Clinical Trial Innovation Summit 

As more clinical trial activities are outsourced to contract research organizations (CROs) and other third party vendors, successful clinical trial execution increasingly depends heavily upon building quality partnerships. Establishing and maintaining realistic and explicit expectations from each partner in the outsourcing relationship is crucial to running efficient clinical trials. Cambridge Healthtech Institute’s Inaugural Outsourcing for Clinical Trials conference features case studies and lessons learned from sponsors and other third party vendors on how to optimize the outsourcing partnership.

Final Agenda at-a-Glance:

Tuesday, May 10


Put Your Money Where Your Mouth Is – Innovative Contract Structures
Sondra Smyrnios, MSc, Vice President, Clinical Operations, Alkermes

Crafting Effective RFPs for Novel Therapy Studies
Kate Nabewaniec, Director, Clinical Outsourcing, Bluebird Bio


Small Fish in a Big Pond: Strategies for Small and Mid-Size Pharma to Successfully Partner with CROs
Marie Rosenfeld, Director, Development Operations, Contracts & Outsourcing Vendor Management Lead, Astellas Pharma Global Development, Inc.

Outsourcing at Small Biotech Companies: How Could CROs Align Themselves Better with the Needs of Their Clients from the Very First Interactions and Project Planning Discussions
Sophie Egholm Chapelle, COO, Senior Management, Cerespir

Presentation to be Announced
Sponsored by: Medidata Solutions, Inc.

Key Considerations and Challenges for Implementing a Preferred Provider Model at a Mid-Sized Biotech
Lisa Sergas, Senior Manager, Clinical Outsourcing, Medivation

PANEL DISCUSSION: CRO & Sponsor Perspective on Meeting Outsourcing Needs and Challenges of Small and Mid-Sized Biotech and Pharma

Wednesday, May 11


A Collaborative Audit Approach of Central Laboratory Partners
Roxana Duque, Compliance Specialist, GQRC-Clinical Trials & Safety, Bristol-Myers Squibb

Partnering Quality with Our Quality Partners: Managing Clinical Trial Quality through Oversight and Collaboration with Our CRO Partners
Christine Block, Executive Director, Quality Assurance GCP, Incyte

Presentation to be Announced
Sponsored by: Unanet

Issue Escalation for Fully Outsourced Studies
Rosemary Dillon, Associate Director, Clinical Outsourcing & Operations, Bristol-Myers Squibb

Vendor/Sponsor Performance Metrics: How Are We Doing?
Randy Krauss, Director, Clinical Process Optimization, Shire

PANEL DISCUSSION: Project Tracking and Establishing Appropriate Metrics from Both the Sponsor & CRO Perspective
Randy Krauss, Director, Clinical Process Optimization, Shire
Timothy S. LaCroix, MBA, Head, Business Development, PharPoint Research, Inc.
Linda Hook-D’Innocenzo, MS, RQAP-GCP and GLP, Director, GCP Compliance, Forum Pharmaceutical

Click here to view speaker abstracts | Register

Pair this program with Patient Recruitment & Site Selection and Dinner Course on Expectations of Risk-Based Monitoring and Pharmacovigilance to maximize your time at the Clinical Trial Innovation Summit!

Take Part in the Clinical Trial Innovation Summit!
Download Final Brochure

Cambridge Healthtech Institute's Fifth Annual Clinical Trial Innovation Summit will bring together leaders from across pharma, biotech and academia to share case studies and best practices on effective clinical trial management and vendor oversight. The 2016 program focuses on key issues and opportunities in the clinical trial industry, including Patient Recruitment, Site Selection, Data Integration, Existing Data Sources, Mobile Tech, Project Management, Outsourcing, Vendor Management, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring and Clinical Auditing.


MAY 9 - 10

Mastering Risk-Based Monitoring
Patient Recruitment & Site Selection
Big Data for Clinical Trials

MAY 10 - 11

Clinical Trial Auditing
Outsourcing for Clinical Trials
Data & Tech Driven Clinical Trials


Special early registration discounts are available. Secure your place by March 11 to save up to $400!
Learn more about sponsorship and exhibit opportunities.

Cambridge Healthtech Institute, 250 First Avenue, Suite 300, Needham, MA 02494, www.healthtech.com 
Tel: 781-972-5400 | Fax: 781-972-5425
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