2018 Archived Content

Cambridge Healthtech Institute’s 4th Annual

Implementing Risk-Based Monitoring – Part 2:  

Ensuring Effective and Efficient Monitoring and Data Quality
February 14-15, 2018 | Hyatt Regency Orlando | Orlando, 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 although RBM takes many forms – remote, centralized, and risk-based monitoring – successful risk-based monitoring implementation requires developing new roles, analytics and processes among the stakeholders in RBM. Cambridge Healthtech Institute’s 4th 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 implementing clinical quality and RBM as well as a prospective look into the future of RBM.

Wednesday, February 14

11:30 am Registration Open

12:10 pm Bridging Luncheon Presentation: Extracting Data from the EHR Dramatically Reduces the Need for Manual Monitoring - New Standards Make this Possible

Kim_RejndrupKim Rejndrup, Senior Vice President, Product Development, OmniComm

The typical workflow at an investigate site is for the patient data to be entered into the Electronic Health Record, then for the study coordinator to re-type that data into the EDC system. A big component of the subsequent Source Data Verification is simply checking that the retyping was done accurately. If data could instead flow automatically from the EHR system, with the coordinator just verifying the data in transit, then both the data entry and the subsequent SDV can be automated. New standards and technologies being introduced under the “SMART on FHIR” umbrella now make this possible. This presentation will describe the state of the art in this exciting new field.

12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Plenary Keynotes

3:00 Valentine’s Day Celebration in the Exhibit Hall, Last Chance for Exhibit Viewing


4:00 Chairperson’s Remarks

David Lacagnina, Technology Entrepreneur, The e-Clinical Agency

4:05 PANEL DISCUSSION: A Cross-Functional Look at RBM from Abbott Nutrition’s RBM Task Force

Sonya_VerrillSonya Verrill, Manager, Clinical Projects, Clinical Operations, Abbott Nutrition


Geraldine_BaggsGeraldine Baggs, Ph.D., Principal Research Statistician, Statistical Sciences, ANRD Scientific and Medical Affairs, Abbott Nutrition

Dione_SmartDione Smart, Research Data Coordinator, Clinical Data Management, Abbott Nutrition

Sue_ZhangXiaosong (Sue) Zhang, MS, MAS, Staff Statistical Analyst, Clinical Program & System Support, Abbott Nutrition

Abbott Nutrition has established a cross-functional RBM task force to address changes brought about by implementing RBM. Members from the following groups: Stats, ClinOps, Programming, and CDM will discuss change management, their successes and challenges, refinements and tools in their journey to implementing RBM.

Medidata4:55 Think You’re ICH E6 Compliant? Show Me the Quality Tolerance Limits

Dan_OConnellDan O'Connell, Principal, RBM Platform Adoption, Medidata

ICH E6 Good-Clinical-Practice Guideline addendum directs sponsors to decide which risks to reduce and/or which to accept, predefining quality tolerance limits(QTLs), taking into consideration the medical/statistical characteristics of the variables and the statistical design of the trial, to identify systematic issues that can impact subject safety or reliability of trial. The presentation will cover history behind QTLs, difference between QTLs and KRIs and mechanisms to establish, track and report deviations of QTLs in the CSR.

5:25 RBM Journey: RBM 1.0 to RBM 2.0 with Case Study on a Pilot

Nurcan_CoskunNurcan Coskun, Ph.D., Global Risk Based Monitoring Program and Technology Solutions Manager, Medtronic

This presentation will discuss: 1. Harmonization of two organizations RBM methodology in Medical Device setting, 2. Future state process development with tools and transition to system and technology solutions, 3. Sharing a case study of RBM 2.0 pilot implementation, and 4. The challenges around change management and getting everyone aligned to the same direction in a multi-BU company like ours as part of the journey.

Cognizant5:50 Reception Hosted by Cognizant Technology Solutions

Thursday, February 15

7:15 am Registration Open

Accenture7:45 Breakfast Presentation: Clinical Trial Operations Insights Evolved via Accenture Life Sciences Cloud

Chandi_KodthiwadaChandi Kodthiwada, Product Manager, Accenture Life Sciences Cloud (ALSC), Accenture

Chances are you have spent a meaningful amount of time on one of the below questions: How do you assess your Clinical Trial operational efficiency? How do I stay on top of Site behavior? How do you maintain Vendor-Oversight? In the presentation, we will go through Accenture Life Sciences Cloud(ALSC) - Clinical Operations Insights Platform(COIP) and our work with Metrics Champion Consortium(MCC) to answer the above questions.


8:30 Chairperson’s Remarks

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

8:35 Best Practices and Observations from Implementing TransCelerate’s Risk-Based Monitoring Model Framework

Suzanne_LukacSuzanne Lukac, Director, Risk-Based Monitoring Implementation, Merck

Although Regulators were urging companies to move to a risk-based approach, no model framework existed to enable organizations to successfully deploy and scale risk-based monitoring. To address this, a collaboration of 18+ Sponsor Companies worked in an unprecedented way to develop a model approach for risk-based monitoring. This session will share the latest work of this initiative, including new tools to assist implementation, best practices for adoption, and post-adoption metrics and observations.

9:00 Developing a Risk Repository

Adrienne_StricklerAdrienne Strickler, Associate Director, Risk Management-Central Monitoring, Janssen

What comes next after your Risk-Based Monitoring process is established? Process improvement! After 4 years of RBM at Janssen R&D, our portfolio has grown to include well over 150 trials and we are now able to gain efficiencies by applying lessons learned across similar studies. One key way to do so is through a central risk repository that can be used to streamline RBM set-up and implementation for new trials.

9:25 CO-PRESENTATION: The Quality Journey - A Small Companies Approach to the Implementation of ICH E6 and RBM

Yiwen_SunYiwen Sun, Senior Clinical Research Associate, Samumed, LLC

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

This presentation will be in two parts, firstly examining the overall quality imperative within the clinical trial arena and the second part will focus on Samumed’s ICH E6 and RBM journey to current status and future direction. Key points: 1. Understand the quality requirement expected of sponsors, 2. What can be achieved by a small company, current status, and 3. Future direction.

10:15 Networking Coffee Break


10:30 Chairperson’s Remarks

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

10:35 RBM: A Larger Sponsor’s Approach

Taras_CarpiacTaras Carpiac, Director, Global Development Operations, Amgen

Amgen began its RBM journey in 2012. In the years since, Amgen has continued to make investments in its RBM process and tools in order to align with regulations and in response to industry developments. This presentation will examine the principles of Amgen’s RBM model and highlight areas of new focus.

Covance11:00 CO-PRESENTATION: The Right Ingredients for RBM Success

Danilo BrancoDanilo Branco, RBM Lead, Senior Manager, Monitoring & Data Flow Optimization, Covance

Aaron_MackeyAaron Mackey, PhD, Director, Data Sciences, Covance

Choosing a RBM implementation plan is like following a cooking recipe – step by step or via experience! Hear from two of our experts as they discuss the RBM landscape for today and tomorrow, and offer real word experiences of RBM. Together, they will provide you with a recipe for success from both a theoretical and operational aspect.

11:25 Brief Session Break

Bioclinica_new11:35 The Past, Present and Future of RBM Technology

Kristin_MauriKristin Mauri, Global Head, Risk Based Monitoring, Bioclinica

12:00 pm PANEL DISCUSSION: What Lies in the Future for RBM?

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


Yiwen_SunYiwen Sun, Senior Clinical Research Associate, Samumed, LLC

Taras_CarpiacTaras Carpiac, Director, Global Development Operations, Amgen

Andrew_ChapmanAndrew Chapman, Senior Director, Informatics & Digital Marketing, Covance

Kristin_MauriKristin Mauri, Global Head, Risk Based Monitoring, Bioclinica

As the biopharma industry perfects the process of RBM, we will discuss the possibilities that lie ahead for RBM and its resulting data: In what capacity will onsite monitoring continue? Can onsite monitoring ever be eliminated? What are some possible uses for the data generated from RBM? Are there data patterns and predictive markers seen in the data?

12:50 Closing Remarks

1:00 SCOPE Summit 2018 Adjourns

Melissa DolenGroup Discounts Are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact Melissa Dolen at 781-972-5418 or mdolen@healthtech.com.



2018 SCOPE Conference at a Glance


For questions or suggestions about the meeting, contact:

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

For partnering and sponsorship information, contact:

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

For media and association partnerships, contact:

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