Cambridge Healthtech Institute’s 3rd Annual

Implementing Risk-Based Monitoring – Part 2:  

Ensuring Effective and Efficient Monitoring and Data Quality
January 25-26, 2017 | Hyatt Regency Miami | Miami, FL


Risk-based monitoring (RBM) approaches promise to improve clinical trial efficiency while ensuring data quality. As industry adoption of RBM increases, it is clear that successful risk-based monitoring implementation requires developing new roles, analytics and processes among the stakeholders in RBM. Cambridge Healthtech Institute’s Third 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 and TransCelerate member organizations on effectively working with various stakeholders in RBM as well as leveraging technology to benefit RBM.

Preliminary Agenda

Arrive early and attend Part 1: Implementing Risk-Based Monitoring – Part 1
Keynotes | Monday Short Courses | Speaker Biographies

Wednesday, January 25 - Thursday, January 26


Bridging Luncheon Sponsored by Omnicomm


AFTERNOON PLENARY KEYNOTES
MOVING TOWARD TRIALS OF THE FUTURE

Plenary Keynote Chairperson’s Opening Remarks & Clinical Informatics News Best Practices Awards
Allison Proffitt, Editorial Director, Bio-IT World & Clinical Informatics News


Two Keynote Sessions – Tuesday Morning and Wednesday Afternoon

  • Tuesday Morning: RE-THINKING THE DESIGN AND PLANNING OF OUR STUDIES
  • Wednesday Afternoon: MOVING TOWARD TRIALS OF THE FUTURE

Featuring:
Murray Abramson, M.D., Vice President, Global Clinical Operations, Biogen
Bardia Akbari, Pharm.D., Vice President, Product Global Development, Oncology, Genentech, Inc.
Robert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
Craig Lipset, MBA, Head of Clinical Innovation, R&D, Pfizer, Inc.
Paulo Moreira, Vice President, Global Clinical Operations - External Innovation, EMD Serono, Inc.
Christine Pierre, President, Society for Clinical Research Sites (SCRS)
John Reites, Head, Digital Health Acceleration, Quintiles
Jeremy Sohn, Vice President, Head of Digital Business Development & Licensing, Novartis
Katherine Vandebelt, Senior Director, Clinical Innovation, Eli Lilly and Company

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



BRINGING TOGETHER KEY STAKEHOLDERS FOR RBM

RBM Change Management Successes: Stories and Lessons Learned
Jean Baumann, Change Management Specialist, JMB Consulting, LLC

PANEL DISCUSSION: Bringing Together Key Stakeholders in RBM
The panel will discuss creating and organizing a successful clinical ops team around implementing risk-based monitoring and the delicate balance in deciding what is essential vs. nice to have for an organization of your size, whether small, mid-size or large.
Brian Nugent, Associate Director, Clinical Operations & Process, Gilead Sciences
Angie Maurer, RN, BSN, MBA, Clinical Operations Consultant, PALM/Clinical Operations, Gilead Sciences
Ken Wu, Clinical Operations Consultant, Kenneth Wu and Associates, LLC


RBM CASE STUDIES

Risk-Based Monitoring (RBM) Case Study
Lynne Cesario, Risk-Based Monitoring Program Lead, Clinical Sciences and Operations, Global Product Development, Pfizer

RBM at Janssen R&D
Stephanie Clark, MA, Associate Director, Risk Management-Central Monitoring, Janssen Research & Development, LLC

Talk Title to be Announced
Jacqueline Gough, Advisor, Clinical Risk Management, Eli Lilly and Company

Sponsor Presentation by Paragon Solutions
Making RBM Work for Your Organization
Karen McCarthy Schau, Principal Consultant, Clinical Optimization Practice, Paragon Solutions


TECH SOLUTIONS TO RBM

Implementing Risk-Based Monitoring Solutions from a System and Architecture Perspective
Michael Bem, IT Manager, Medicines Development, Eli Lilly and Company

Novel Approaches to RBM That Are Less Time Consuming and Resource Intensive: Two Examples from Novartis – Central Statistical Monitoring and Virtual Site Visits
Grant Simmons, Director, ClinOps Insights & Innovation (CII), Global Operations Services, IDFR, Novartis Pharma

CO-PRESENTATION: Searching for a Technology Solution to Support Risk-Based Monitoring (RBM)
Ed Kellar, Director, Global Data Management Operational Support, Astellas, Inc.
Mary Cusack, Associate Director, Global Clinical Operations, Bristol-Myers Squibb

Arrive early and attend Part 1: Implementing Risk-Based Monitoring – Part 1
Keynotes | Monday Short Courses | Speaker Biographies

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 Director
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5404
E: lyuan@healthtech.com

For partnering and sponsorship information, please contact:

Ilana Quigley
Senior 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




Signature Sponsor

Bio Clinica Logo

Premier Sponsors

BBK  

ClinicalInk

Comprehend

OmniComm

PRA Health Sciences

QUINTILES

> All Sponsors

> Media Partners

> 2016 Attendee List

> 2016 Attendee Profile