April 2022 • Archived Content

Cambridge Healthtech Institute’s 4th Annual

Risk-Based Quality Management and Monitoring

Beyond COVID-19: Tools and Processes to Accelerate RBQM and Improve Monitoring

20 - 21 April 2022 CET

Where RBQM implementation had proceeded in a conservative, iterative manner pre-pandemic, but the challenges presented during this unexpected crisis have resulted in acceleration of RBQM adoption and on-site and remote monitoring practices in clinical trials. With the backdrop of lessons from COVID-19, CHI’s 4th Annual Risk-Based Quality Management and Monitoring conference provides processes and tools for acceleration of RBQM implementation, regulatory requirements, QTL & KRI setup and monitoring, early risk and issue detection, and monitoring approaches. The gathering will be part of the Summit for Clinical Trials Operations Executives (SCOPE) Europe, a two-day event made up of shared plenary keynotes from biopharma thought leaders, 4 conference tracks focused on specific issues and functions within the clin ops, innovation and research enterprise, informal and interactive breakout discussion groups, and networking. Please join us at this year's "Risk-Based Quality Management and Monitoring" conference at SCOPE Europe, a hybrid conference in 2022 serving both in-person and virtual attendees.

Wednesday, 20 April

06:30 Breakfast at the Hotel Restaurant, Arrel

Complimentary for SCOPE Europe Intercontinental Hotel Guests Only

07:30 Registration and Morning Coffee (Foyer)



08:50 Welcome by Conference Organizer

Bridget Kotelly, Senior Conference Producer, Cambridge Healthtech Institute (CHI)


Chairperson's Remarks

Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline

RBQM Execution in Full-Service Outsourcing Models

Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline

Sponsor organizations must oversee the execution of trials when those are outsourced to CROs. This includes oversight of risk-based quality management strategies. This may be somewhat challenging in full-service outsourcing models when CROs are using their own procedures, tools, and processes. The presentation will include key risks to RBQM planning and execution in outsourced models and oversight model that may be applied to mitigate the risks. 


Pivoting to Patient-Centric Trial Design: Risk-Based Management of Decentralized Clinical Trials

Kavita Rattan, PhD, Lead, AI-Data Sciences & RBM, Data Monitoring & Management, Pfizer Inc.

Decentralized clinical trials (DCTs) offer multiple benefits including enhanced patient experience, high quality data and the agility to manage disruptions, e.g. COVID19 pandemic. Implementing an effective decentralized solution requires a robust RBQM process that allows early identification of risk and centralized monitoring can be a key component of a decentralized design to inform timely decision making. This presentation will discuss case studies and risk analytics for successful management of DCTs.

Joseph Goodgame, Co-Founder and Chief Technology Officer, Remarque Systems

Artificial intelligence technology, including machine learning (ML), is an increasingly hot topic in clinical research. There are still important questions to be answered when putting these systems into action though. This session will help set your organization up for success by offering a fresh perspective on key goals of risk-based quality management (RBQM) and how you can best implement ML as part of this process for streamlined and effective data exploration.


Implementation of Central Monitoring: Guiding Principles for Widespread Adoption and Maximum ROI

Pablo Bravo, Senior Manager, Central Risk, Syneos Health

Central Monitoring has been encouraged since ICH E6 (R2) in 2016, but adoption has been slower than anticipated.  Obstacles to implementation include access to data, data format and standards, cost and complexity of analytical tools to visualize data, integration into clinical monitoring process, where in the organizational structure central monitoring is best aligned and what skillsets are needed for those primarily responsible for conducting the analyses.  Establishing a few guiding principles can help overcome these challenges resulting in greater adoption and successful return on investments.  This session will explore one organization’s strategy and lessons learned.  

11:00 Coffee Break in the Exhibit Hall (Verdi)



11:45 KEYNOTE PRESENTATION: Chairperson's Remarks
Darcy Forman, Chief Delivery Officer, Science 37
Darcy Forman, Chief Delivery Officer, Science 37
Cristina De Juan, PhD, Innovation Lead, Global Clinical Sciences and Operations (GCSO), UCB
Sam Hariry, Global Head, Clinical Innovation, Novartis Institutes for Biomedical Research

The biopharma, medical device, digital medicine, healthcare and tech industries involved in clinical research are learning from one another, improving innovation, re-thinking business process, and expanding what used to be a much more siloed ecosystem. These are exciting times, but it is a very complex garden to navigate. How do we continue to innovate beyond pilots? How do we scale innovation and collaborate across departments, companies and industries to improve clinical trials and research?


Digital Health in the Circular Economy, Novel Partnerships Required

Bert Hartog, PhD, Senior Director Clinical Innovation, Janssen Pharmaceutica NV

The talk will be about the environmental impact of digital health, and how circular economy principles can help minimize eWaste and maximize repurposing, reuse and recycling of digital health technologies.


What Can Clinical Innovation Teams Learn from Digital Health Startups?

Panel Moderator:
Francesca Wuttke, PhD, CEO and Founder, nen

Working with startups can provide the Pharma industry with the innovation capabilities required to accelerate the digital transformation of the company, while embedding a culture of experimentation where there is freedom to try and fail, through the exposure to and collaboration with young and risk-taking startups. Partnering with Startups offers Pharma access to solution-driven technology which allows them to accelerate their growth and drive strategy.

Andrea Coravos, CEO & Co-Founder, HumanFirst
Bert Hartog, PhD, Senior Director Clinical Innovation, Janssen Pharmaceutica NV
Nader Alaghband, Co-Founder & CEO, Ampersand Health
13:20 Join Your Peers for a Networking Luncheon in the Exhibit Hall (Verdi)



Patrick Hughes, Co-Founder and Chief Commercial Officer, CluePoints SA

GCP Renovation: The Impact of ICH E8 and ICH E6 Revision

Kerstin Koenig, PhD, Vice President, Global Head Research & Development Quality, Bristol-Myers Squibb
Rebecca Stanbrook, Executive Director, Development and Regulatory Policy, Novartis

January 2017 saw the publication of the reflection paper from ICH on GCP Renovation.  The single largest update to ICH guidelines surrounding clinical trials.  The first of these for revision was ICH E8 and the renovation of E6 started sometime later in 2019.  With the release of the final text for E8 and the publication of draft principles of E6 for information, this is an excellent time to hear from the 2 EFPIA topic leads on these important guidelines.  This presentation will cover the background to the renovation efforts, provide a review of ICH E8, and an update on the current progress of E6?.


MSD's Risk-Based Approach to Protocol Deviation Processes

Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, MSD
Carolyn Da Silva, Associate Director, Global Clinical Trial Operations, MSD


Striving to do high quality work is a good trait, especially for clinical trials. MSD will share a story from the past, how they got SMART and why they now focus on what matters by embracing a risk-based approach to the management of protocol deviations.

Francois Torche, Co-Founder and Chief Executive Officer, CluePoints

In this session you will: Understand the evolution of risk-based techniques over the past 10 years and the increasing role of novel analytical techniques to support a risk-based approach. Understand the role of Deep Learning and Machine Learning in delivering better insights to Data Managers/Analysts and study team members to make better and more targeted decisions. Gain lessons learned from a case study on the role of RBQM during the pandemic.

16:25 Interactive Discussions

Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by facilitators who keep the discussion on track and the group engaged. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussions Page for a complete listing of topics and descriptions.

IN-PERSON INTERACTIVE DISCUSSION: Advanced Analytics and Artificial Intelligence in Clinical Trials

Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline
Abhinav Uppal, Decision Analytics Manager, ZS
Niraj Vyas, MD, AVP and Head, TCS ADD Analytics and Insights, TCS
  • AI applications in clinical data management 
  • Advanced analytics and AI capabilities driving quality compliance 
  • Machine learning techniques that are in production in various organizations that are adding value and accelerating clinical development 
  • How to pick an AI/ML use case and move it from idea to implementation quickly​
17:05 Welcome Reception in the Exhibit Hall with Beer, Wine and Tapas (Verdi)
18:00 Close of Day

Thursday, 21 April

06:30 Breakfast at the Hotel Restaurant, Arrel

Complimentary for SCOPE Europe Intercontinental Hotel Guests Only

08:30 Registration and Morning Coffee (Foyer)




Chairperson's Remarks

Wim Nijhoff, Global Director & Senior Clinical Quality Management Lead, EMD Serono

New Frontiers in Risk-Based Quality Management: From Simulation to Practice

Andrzej Kinasiewicz, PhD, Team Manager, Centralized Monitoring, Site Quality Risk Management, AstraZeneca
Jakub Tyszecki, Associate Director, Centralized Monitoring, AstraZeneca

Current applications of RBM across the industry focus on reducing expenditures associated with onsite monitoring. Nowadays, pharma is still dealing with reduction of SDV, which has been confirmed as bringing extremely limited value. We look to demonstrate there is room for further significant reductions in site monitoring. By applying Bayesian Network Monte Carlo simulations we model detrimental site behaviours and evaluate their impact on overall study quality.


The Monitoring Process Changed: How Do You Know It's Working?

Keith Dorricott, Ambassador, Metrics Champion Consortium

Your monitoring process includes a combination of centralized, remote and onsite monitoring of your clinical trials. Have you updated the metrics that you are using to oversee the new integrated process? Are you using the right KRIs? Are identified risks turning out to be actual issues? Are your monitors focusing on the most important risks and issues? Are site issues being addressed? These are questions that a multi-stakeholder group has been exploring at an industry consortium. Find out about the approach, the challenges, and some of the new monitoring metrics developed by the group.


Data-Driven Sponsor Oversight of Outsourced RBM

Wim Nijhoff, Global Director & Senior Clinical Quality Management Lead, EMD Serono

RBM is now incorporated as a GCP expectation in most ICH regions and  by regulatory agencies. Sponsors are accountable to ensure proper oversight of the execution when activities are outsourced to CROs. In addition, the COVID-19 pandemic showed the importance of centralized, data-driven sponsor oversight to ensure patient safety and high-quality clinical trial data. This session will explore Merck KGaA’s strategy on sponsor oversight.

Amy Adams, Senior Director, Clinical Operations, Parexel
Liz Gough, Associate Director, Project Management Processes, Parexel

This session will introduce a holistic approach to risk management from study start to finish.  Identifying critical data and processes establishes core factors driving the study objective. What are the keys to success for this vital foundational activity?  At the same time, expanded risk considerations take risk evaluation beyond column-fodder to deliver on the promise of RBQM.  We’ll explore the importance of critical thinking and supporting systems at each phase.




Reimagining Clinical Trials: The Digital Transformation in Catalonia

Panel Moderator:
Montse Daban, Director, Scientific and International Relations, Biocat

The healthcare community agrees on the need to foster digital transformation throughout the entire healthcare value chain, including the framework for the clinical validation of innovative technologies, i.e., the evidence for real-world positive and significant health outcomes for patients and society. The final objective is to accelerate technology adoption, provide support for the validated ideas, and improve their market access. The session will share perspectives of actors connecting clinical research and industry in a comprehensive way and it will highlight the successful coordination in clinical trials key stakeholders in Catalonia.

Montserrat Barcelo Riera, MD, Vice President, Europe, Veristat
Xavier Cañas, Director, Promotion and Development of Clinical Research, Vall d’Hebron Hospital
Alessandro Monterosso, Director, Digital Health Solutions, Alira Health
Oriol Penon, PhD, Business Account Director, ASPHALION
11:05 Coffee Break in the Exhibit Hall (Verdi)



Chairperson's Remarks

Elke Van Mol, R&D Global Functional Lead Clinical Trial Managers, Clinical Operations, Janssen Pharmaceutica NV

Harnessing the Power of Real-World Data for Clinical Research: European Initiatives

Dipak Kalra, PhD, President, European Institute for Health Records & President, European Institute for Innovation through Health Data

Real World Data has historically been regarded as siloed within healthcare provider systems (and therefore fragmented, difficult to access at scale), with patchy coverage and often of poor quality - so not very reliable for research. A further barrier is data protection legislation, in Europe with the GDPR. Large-scale research infrastructure initiatives are now being established across Europe to tackle these issues and to make RWD more available for observational data studies and the reuse of EHRs for clinical trials. This talk will present this exciting landscape, including the Commission proposals for a European Health Data Space, and explain how some of the perceived issues with RWD are being tackled, including winning public support for the use of RWD by industry.


Hybrid and Decentralized Trials: The Future Is Here

Panel Moderator:
Elke Van Mol, R&D Global Functional Lead Clinical Trial Managers, Clinical Operations, Janssen Pharmaceutica NV

Covid-19 has played an extreme catalyst role in implementing existing digital and remote clinical trial solutions and has been the engine behind rapid evolution of a few new capabilities. Some of these newly deployed capabilities are quick fixes for the emergency that COVID brought to our day-to-day trial operations, while many will benefit from the catalyst effect and will probably be the new standard even after COVID. Today, we have the chance to continue driving adoption of decentralized clinical trials – and innovating to advance the benefits DCTs offer to patients, sites and sponsors.

Dipak Kalra, PhD, President, European Institute for Health Records & President, European Institute for Innovation through Health Data
Cristina De Juan, PhD, Innovation Lead, Global Clinical Sciences and Operations (GCSO), UCB
Kavita Rattan, PhD, Lead, AI-Data Sciences & RBM, Data Monitoring & Management, Pfizer Inc.
Lisa Moneymaker, Senior Vice President, Clinical Operations Technologies, Medidata, a Dassault Systèmes company
Sidharth (Sid) Jain, Head, Global Dev Data Science Strategy & Portfolio, Janssen Pharmaceuticals Inc
12:55 Join Your Peers for a Networking Luncheon in the Exhibit Hall (Verdi)



Johann Proeve, PhD, Chief Scientific Officer, Cyntegrity

Evolution of Clinical Investigator Site Audits as a Result of the Pandemic

Nuria Gomez Mas, GCP Auditor, EMEA, Janssen

The global pandemic challenged us all to think outside of the box. The pandemic has offered auditors a way to adapt successfully and to evolve our methodologies. Through innovative thinking and increased use of technology, we have taken audits from onsite to a more virtual approach. A remote audit ensures involvement with investigational site staff with key source data review while a hybrid audit includes a limited onsite portion with the involvement of an eyes and ears role. This evolution has shown the delivery of high-quality audits that will offer sustainable options for audit conduct now and for the future.

Saurabh Das, Head Research & Innovation for TCS ADD, and Head, TCS ADD Analytics and Insights, TCS
Kris Lauwers, Manager, Advanced Insights, Janssen R&D

Lack of clinical operations oversight and disjointed communication at site & study levels have proved to be detrimental for the life sciences industry. The pharma organizations need to leverage a data science led approach to address these complexities. During the course of this session, the speakers will touch upon some novel approaches and enablers in dynamic monitoring and support them with a real-life use case.


Case Study: Solving for the Challenges of Unblinded Monitoring in Double Blind Studies

Alexandra Kessler, Regions Operational Excellence Director, MSD

Many sponsors face important operational challenges when they  split monitoring in blind and unblinded roles. You need two teams  with the impact on cost and resources but you also increase the operational risk of unblinding the blind team. Your systems may not be ready to build a firewall. Human error plays a role too and suddenly you end up managing several quality issues related to unintentional unblinding. After attempts of  adjusting  processes, MSD rolled out a new innovative and flexible  operating model in collaboration with a CRO partner, enabling us full oversight and control, minimizing the risks.

Irina Groysman, Change Management, Communications Expert, ZS
Vera Pomerantseva, Quality and Risk Management Lead, Zs

BQM approach is rapidly evolving beyond site and project level monitoring. How can you bring your organization to the level of enterprise-wide quality risk management? How can your organization use analytics to manage process quality risks, oversee vendors and re-design continuous improvement process? How can you engage your people in this new way of working?

Join our session to learn:  

Our advanced approach to enterprise-level analytics and related benefits.

The importance of people focused change management and gamification to successfully implement RBQM  



The Role of Patients, Data, and Patient-Facing Technologies in Clinical Trial Design: Lessons from COVID-19 Pandemic

Panel Moderator:
Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine

Patient centricity has been discussed in industry circles for quite some time now, with sponsors connecting it to either reduced protocol assessments or increased use of technology in trials. The industry still has a lot to learn about patient-centric trials, but having patients’ input will help to gain their perspective and better understand their concerns during and after COVID-19. This session will provide a large inventory of countermeasures to offset challenges brought on by COVID-19 pandemic, including: clinical trial design from a site perspective, patient-centric digital solutions, creating an inclusive/equitable environment, collaborating within regulatory affairs.

Mats Sundgren, PhD, Director, Health Data Science, AstraZeneca R&D
Robert Kroes, International Associate Director TA Analytics , Marketing Analytics, Lilly Nederland BV
Florin Sirzen, MD, PhD, Senior Director, Medical Affairs, F. Hoffmann-La Roche
Alicia Staley, Vice President, Patient Engagement, Medidata, a Dassault Systèmes company
Hilde Vanaken, PhD, Head Industry Leaders, Life Sciences and Healthcare, TCS
16:30 Closing Remarks

Bridget Kotelly, Senior Conference Producer, Cambridge Innovation Institute

16:35 Close of Conference