Cambridge Healthtech Institute’s 5^th Annual

Implementing Risk-Based Monitoring – Part 2

Ensuring Effective and Efficient Monitoring and Data Quality

February 20-21, 2019

Risk-based monitoring (RBM) approaches promise to improve clinical trial efficiency while ensuring data quality. As industry adoption of RBM increases, it is critical to reflect on lessons learned to refine the process as well as focus on leveraging RBM data for clinical operations. Cambridge Healthtech Institute’s 5^th Annual “Implementing Risk-Based Monitoring – Part 2: Ensuring Effective and Efficient Monitoring and Data Quality” conference offers case studies and practical solutions from across pharma on effectively implementing clinical quality and RBM as well as a prospective look into the future of RBM.

Arrive early and attend Part 1 (Tues-Wed): Implementing Risk-Based Monitoring – Part 1

Wednesday, February 20 – Thursday, February 21 (Part 2 of SCOPE)

Bridging Luncheon Presentation (Sponsorship Opportunity Available)

What Should CROs Do to Protect Sponsors Undertaking RBM Trials?

Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

PANEL DISCUSION: CRO Oversight, RBM and ICH E6 R2

Panelists:

Sarah Bednarski, Associate Director, Strategic Monitoring, Sunovion

Ann Hegarty, Executive Director, GSMO, Head PLs, CRO Oversight & Ph I Site Management, Allergan

Jill Collins, Executive Director, Global Operations Management, Syneos

David Nickerson, Head, Clinical Quality Management, Global Clinical Operations, EMD Serono

How to Succeed when Implementing a Central Monitoring Solution in Your RBM Program, Considerations You Should Not Avoid

John Kim, Senior Manager, Business Technology, Pfizer

Talk Title to be Announced

Mary Arnould, Director, Clinical Science Operations and RBM Lead, Astellas

Leveraging RBM Data to Drive Study Quality

Nechama Katan, Central Monitoring Manager, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer

PANEL DISCUSSION: How Is Data Collected from RBM Affecting Study Quality/Integrity and Driving Site Selection Decisions?

Panelists:

Amy Neubauer, Associate Director, Data Management, Alkermes, Inc.

Nechama Katan, Central Monitoring Manager, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer

Luncheon Presentation (Sponsorship Opportunity Available)

Monday Evening, Tuesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2019 Participant Engagement Award, in Memory of Jerry Matczak
Empowering Humans to Own Their Own Data
Digital Trends That Are Changing the Healthcare Experience
Why Do We Need Caregivers in Clinical Trials; Exploring Real-life Applications in Engagement and Retention
Welcome, Pharma, to AI. Here’s What You Have Been Missing.

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

Arrive early and attend Part 1 (Tues-Wed): Implementing Risk-Based Monitoring – Part 1

For more details on the conference, please contact:
Lee Yuan

Conference Director

Cambridge Healthtech Institute (CHI)

Phone: 781.972.5404
Email: lyuan@cambridgeinnovationinstitute.com

For partnering and sponsorship information, please contact:

Companies A-O

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: 781.972.5457

Email: iquigley@healthtech.com