Cambridge Healthtech Institute’s 6th Annual

Implementing Risk-Based Monitoring – Part 2

Strategy, Data and Technology Solutions for RBM

February 20-21, 2020

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. CHI’s 6th Annual Implementing Risk-Based Monitoring – Part 2 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 (Wed - Thurs): Implementing Risk-Based Monitoring – Part 1

Final Agenda

Thursday, February 20

11:30 am Registration Open  (Regency Rotunda)

12:30 pm Enjoy Lunch on Your Own

1:00 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)BioTelResearch


2:00 Afternoon Plenary Keynotes (Regency Ballroom S)

3:10 Booth Crawl & Refreshment Break in the Exhibit Hall. Last Chance for Exhibit Viewing (Windermere Ballroom)

Regency Ballroom V

4:10 Chairperson’s Remarks

Christopher BiddleChristopher Biddle, Associate Director, Risk Management and Central Monitoring, The Janssen Pharmaceutical Companies of J&J

4:15 RBQM – Establishing an End-to-end Quality Management Approach to Enable Risk-Based Solutions in Any Organization

Cesario_LynneLynne Cesario, Risk Based Monitoring Program Lead, Clinical Sciences and Operations, Global Product Development, Pfizer

4:45 Taking RBM for a Test Drive – How Trying before You Buy It Can Optimize Deployment Success

Lewis_RachelRachel Lewis, Director, Project Management, Project Management Office, Global Clinical Trial Operations, Merck

Selection of the optimal RBM technology solution to ensure clinical data quality and maximum efficiency is critical for implementation success in any company. However, with the rapid growth in solutions available, how do you choose the right one? We will discuss the advantages, disadvantages and considerations for conducting a pilot of multiple solutions using internal study data to drive sound selection and optimize deployment success.

WorldwideClinicalTrials_horizontal Saama-Technologies 5:15 The Journey from Theory to Competence

Rosie McKellar, Vice President, RMB, Worldwide Clinical Trials

5:45 PANEL DISCUSSION: Moving Past the “i” in RBM: Partnership, Oversight, and Achieving Common Goals between Sponsor, CRO and Vendor

Bednarski_SarahCo-Moderators: Sarah Bednarski, Associate Director, Strategic Monitoring, Clinical Operations, Sunovion Pharmaceuticals

Hamilton_GayleGayle Hamilton, Associate Director, Risk Based Monitoring, Project Operations and Business Performance, IQVIA

Panelists: Speakers of the Day

There are a variety of factors that may be complicating how sponsors, CROs and vendors work together in the RBM space: the formalized R2 requirement for “oversight”, the continuous evolution of RBM, the move past home-grown pilots, etc. There’s more than one right way to implement RBM, but in the outsourced model, establishing a common goal and a way to work together are both critical to success.

  • What are your goals with RBM? This is an interesting opportunity to hear how goals differ between CROs, vendors and sponsors.
  • If you were to go back to when you first starting working with your CRO/vendor/sponsor knowing what you know now, what would you do differently? E.g. Hold a combined training session; hold an expectations meeting with best practices from prior experiences; etc.
  • What successes have you had? What are you still working on improving?
  • In a collaboration between sponsor and CRO/vendor, what roles are important? E.g. Study team roles, specific functions, process-level roles across studies, etc.
  • What, if any, limitations on transparency exist from CRO/vendor to sponsor or from sponsor to CRO/vendor, and have those limitations been overcome in some way?

6:15 Networking Reception (Manatee and Spring Foyer)

7:15 Close of Day

Friday, February 21

7:15 am Registration Open  (Regency Rotunda)

7:45 BREAKFAST PRESENTATION: Breaking Down the Roadblocks to Site Activation (Regency Ballroom T)

Johnston_JillJill Johnston President, Study Planning & Site Optimization, WCG

8:15 Session Break

Regency Ballroom V

8:20 Chairperson’s Remarks

Steve Young, CSO, Management, CluePoints

8:25 Risk-Based Monitoring in 2020: What Practical Lessons Can Veteran Companies Share?

Halloran_LaurieModerator: Laurie Halloran, CEO, Halloran Consulting Group

Melvin_CarriePanelists: Carrie Melvin, Vice President, Global Clinical Sciences and Delivery TA Head of Oncology, GSK/TESARO

Parthasarathy_VinodVinod Parthasarathy, Senior Director, MC2 Global Monitoring & Clinical Operations (Japan & China), Medtronic

Unger_CaroCaro Unger, Senior Clinical Operations Standards and Innovation Manager, Clovis Oncology

Laura Whitmore, Head, Clinical Operations, Oversight, Cerevel Therapeutics

The FDA’s guidance on Risk-Based Monitoring has been in use since August 2013, and the ICH E6 R2 has recently pushed the issue of using risk-based approaches to streamline the overly complex processes that cost life sciences sponsors so much and add so little. But, given that we tend to wrestle with “the way it’s always been done” – how has the adoption been progressing in both early adopters and companies new to the more expanded use of technology to enhance their adoption of risk-based approaches? On our panel, we will discuss how companies have fared and what practical lessons can be shared to facilitate adoption by other companies using the right-sized approach.

  • How has trial design evolved in a risk-based approach?
  • What is different in start-up: selection of sites and vendors, training of the entire team?
  • If you aren’t doing it now, what is holding you back?
  • The centralized monitoring role: What should we know to set up and manage the effort?
  • Are there lessons learned and best practices that can be shared around remote site and even remote patient visits?


WIRB_CopernicusGroup 9:55 Talk Title to be Announced 

Nathaniel Katz, MD, MS  Chief Science Officer, WCG Analgesic Solutions  WCG

10:25 Networking Coffee Break (Session Room Foyer)


10:55 Chairperson’s Remarks

Janis Little, Vice President, Global R&D Quality, Allergan

11:00 Assessing Your Clinical Quality Management System: A Comprehensive Review of TransCelerate’s CQMS Assessment Tool

Little_JanisJanis Little, Vice President, Global R&D Quality, Allergan

This session will help attendees assess clinical Quality Management Sessions to adhere to ICH E6R2 and prepare for future renovations and modernization of E6 and E8.

11:30 Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development

Chow_AllanAllan Chow, PharmD, Senior Manager, Quality & Compliance Risk Management, Amgen

Effective quality risk management is fundamental to ensuring the protection of human subjects and reliability of clinical trial results during the conduct of clinical trials. Quality risk management supports effective delivery of clinical development programs and ultimately delivery of treatments to patients. Thus, risk management is a core element of an effective quality management system (QMS) as described in the TransCelerate Clinical Quality Management System (CQMS) conceptual framework.

12:00 pm Transition to Shared Sessions


Chairperson’s Remarks

Neil Weisman, President, Continuum Clinical

12:05 The Connected Patient: A “One Stop Shop” for Trial Information and Data

McBride_MeganMegan McBride, MPH, Associate Director, Janssen Clinical Innovation, GCDO, R&D, Janssen, The Pharmaceutical Companies of Johnson & Johnson

Learn how we are creating a connected experience for trial participants before, during and after the trial where patients can access meaningful information, their individual data to share with their EHR, aggregate study results and provide ongoing feedback and insights to ensure a better experience for patients, caregivers and the site teams. Explore the possibilities to remain connected via communities to raise awareness around trials. The audience can gain insights as to the ins and outs of how we managed to create a platform to share data directly with patients – from legal, privacy, regulatory and other key stakeholder hurdles to our vision for broadening the scope of data sharing across industry.

12:35 INTERACTIVE PANEL: Translating Virtual to Reality: Decentralized Trial Transformation

Myles_JaneModerator: Jane Myles, Head, Operational Intelligence and Innovation, Roche

Forman_DarcyPanelists: Darcy Forman, Vice President, Clinical Operations, Science37

Kadhim_HassanHassan Kadhim, Director, Clinical Trial Business Capabilities, GCO, Bristol-Myers Squibb

Melvin_CarrieCarrie Melvin, Vice President, Global Clinical Sciences and Delivery TA Head of Oncology, GSK/TESARO

McBride_MeganMegan McBride, MPH, Associate Director, Janssen Clinical Innovation, GCDO, R&D, Janssen, The Pharmaceutical Companies of Johnson & Johnson

Our expert panel will include a variety of perspectives and the aim is to provide pragmatic solutions and actionable advice to make virtual trials a realistic option for your study needs. We’ll discuss strategic and tactical needs to help you determine how to navigate and implement virtual and decentralized options to drive your pipeline goals. Topics to be discussed include:

  • Discuss the settings for virtual trials and help define best fit options for study needs.
  • How and when does the regulatory strategy get set to enable a successful filing?
  • What are the challenges to drive both site and patient participation in virtual trials?
  • What are the timeline and cost differences in planning for and executing virtual trial components?
  • What are the key lessons learned from those who have been early adopters and champions?

1:05 Transition to Lunch

Teckro 1:10 SCOPE Send Off Luncheon Presentation: Is Your Paper Protocol Really Fit for Purpose?

Brendan Buckley, MD, DPhil, Chief Medical Officer, Teckro

When did you last use a telephone directory for a restaurant booking? It might seem absurd to flip through a dated paper directory when the latest information is always searchable online. Why, then, are we still using paper protocols to manage clinical trials? It’s time we bring clinical trials into the digital era. Join this session to find out how to transform your protocol into actionable data for research staff, study teams and CROs.

1:40 Closing Remarks

1:45 SCOPE Summit 2020 Adjourns


Tuesday Evening, Wednesday Morning and Thursday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes:
For more details on the Participant Engagement Award:


Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing:

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