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eDigital DMEG

eDigital Data Management Expert Group

The eDigital data management expert group focuses on driving thought leadership discussions on how current innovative digital technologies are changing and enhancing the resources available to data managers. The group meets on a monthly basis to develop tips and tricks to the wider ACDM community by utilising our collective experience and by inviting topic experts to provide additional background to enhance our understanding.  
ACDM’s eDigital team are currently discussing elements of GDPR, Wearables and EHR integration. They have produced one Q&A write up where they have asked key questions on GDPR to qualified professionals and in addition to this they hosted Q&A sessions with Francis Kendall from Cytel on EHR integration at their April meeting.
 
The eDigital group aims to further the development and skill-set of our wider ACDM community and would be delighted to invite more members to our growing eDigital team. We look forward to hearing from you.
 
If you have any interest in joining this group, please click here

eDigital Expert Group outputs

How to reduce the burden of wearables implementation in clinical trials
Date: May 28, 2020
Click to access output

Infographic – What do Data Managers need to know when considering wearables for their data collection?
Date: May 6, 2020
Click to access output

GDPR in relation to Clinical Data Management.
Date: March 26, 2020
Click to access output

eDigital Expert Group members

Lauren Ellis-Hill (Chair)
Business Development Manager
Cytel

Expanding on my background in Microbiology and Immunology, I started in pharmaceuticals 11+ years ago, which enabled me to connect with healthcare providers about drug treatment effects and the impact on the patient. Since then I have followed my curiosity; across clinical trials, medical devices, working in hospitals alongside nurses and doctors, into software that has the capacity to enhance our efficiency and to get new insights to further improve our understanding of disease states and what patients experience in the real world. In my role at Cytel, I am focusing on software in clinical trial design including key strategic considerations and trade-off analysis, patient recruitment forecasting, quantitative decision making and data analysis.

I chair for the ACDM’s (Association of Clinical Data Management) eDigital Data Manager Expert Group, who contribute content to the ACDM webpage in order to provide guidance to our data management community. I am also the Director of Operations for HBA’s (Healthcare Business Association) London Chapter, taking the lead on the organisation and structure of our strategic board meetings and managing the operations team

Hannah Bausch
Senior Clinical Research Professional
Esculape

Hannah started her career as Data Manager on the CRO side of clinical studies and quickly came to appraise the challenges and the potential of an ever growing digitalized world for data integrity and validity and gained considerable insight into the processes and complexities associated with the setting up of electronic devices for the usage in clinical studies.  During her time there she also broadened her field of action by working in the realm of Clinical Operations and Medical Writing.

However, Data Management was always at the core of her interest which led to her focussing solely on this task by joining a company providing Data Management. Since then, she has acquired solid knowledge on the sponsor perspective on clinical studies and has broadened her knowledge regarding the CRO perspective, leading to an integrated view on the respective needs and requirements regarding Data Management.

Hannah recently joined the eDigital Team.

 

Sverre Bengtsson
Co-founder
Viedoc

Sverre Bengtsson started working as a statistician and data manager in the mid 90’s with probably the world’s first ePRO Minidoc. Minidoc was a perceived as a very user friendly and portable patient diary (as they were called then) and it was praised by the users for it’s high tech interface, it was so small and light weight. It weighed approximately 1 kg (2 lbs) and had four buttons where you could give your answer to multiple choice questions. Imagine this today!

Sverre worked for many years in data management for all kinds of paper CRF trials, the largest one had over 11,000 patients which needed massive amounts of binders and file cabinets. In the late 90’s Sverre managed his first global remote trial and used a more proper remote trial software in 2001.

In 2003 Sverre co-founded Pharma Consulting Group, a CRO who developed Viedoc EDC, where he has since focused on the business side. The CRO was later sold and he now focuses on Viedoc Technologies. Sverre has always been fascinated by the opportunities the e-clinical gives us. In 2011 Sverre co-founded the Swedish CRO association ASCRO. Sverre is active in many organisations within clinical research, including Eucrof, DIA and others.

Today, besides working at Viedoc, he sits on a number of boards and advisor roles.

Alexandra Botezatu
Associate Director of Data Management
Signant Health

I joined CRF Health (now Signant Health) in 2017, after 4 years of experience in Quality Management and Continuous Improvement for Outsourcing services. I am a graduate of ‘Alexandru Ioan Cuza’ University from Iasi, Romania with a BS in Political Science and Master of Public Policy and Institutional Management. My area of expertise is Operations Excellence, Process Scoping and Standardization, Quality methodologies & Continuous Improvement.

I first joined ACDM during the 2019 conference and because the information shared during those days proved to be of increased value in my work, I decided to continue with the organization and joinedthe eDigital & CDM Metrics teams. I chose these two groups because the topics directly impact the activity of Signant Health as a software and service provider in the CDM environment.

Jennifer Bradford
Head of Data Science
Phastar

I am head of Data Science for the global CRO PHASTAR working closely with our data operations team and external clients to lead the delivery of innovative data science solutions. Previously I worked for the Advanced Analytics Group at AstraZeneca, leading the development of the REACT clinical trial monitoring tool, which I went on to deliver to other sponsors as part of Cancer Research UK (CRUK). Within CRUK and in close collaboration with the Christie hospital I worked on electronic data capture, app development and wearables data analytics in the context of clinical trials. I have a degree in Biomedical Sciences from Keele University and a bioinformatics Masters and PhD from Leeds University.

I first joined ACDM during the 2019 conference and was excited to join the eDigital expert group given the relevance of the topics to my own interests and work at PHASTAR.

Mariateresa Garcia
Senior Clinical Data Manager
Spanish Clinical Research Network

Vishal Kapoor
Group Manager, Clinical Data Sciences & Systems
Terumo

Vishal is a systematic leader with a keen focus on adding value in end to end Clinical data management solutions & systems. He has demonstrated his comprehensive 14 years of data management expertise across various therapeutic areas in pharmaceutical (MSD/Merck & Co.) and medical devices (Terumo).He strives to build relationships within his team and with internal/external stakeholders to accomplish business goals. His experience has made him well equipped in the area of Clinical Data Management infrastructure, processes, strategies and leadership, Project Management, Clinical IT systems (EDC, CDMS, CTMS, eTMF, ePRO, commercials), database programming, quality management, RBM and Data Standardizations CDISC. He is actively working on strategies for adopting AI machine learning and AI methodologies to generate insights from data to support (virtual) viable clinical trials.

Tracey Lavery
Manager, Clinical Data Management
ONO Pharma UK ltd

The majority of my career has been in Data Management, working for a number of large pharmaceutical companies and using different technologies and conducting different tasks. Over the last 10 years I have been involved in working with and developing better relationships with outsourced vendors, this also included training offshore DM’s. I have also been involved with improving our oversight, developing better metrics and documentation.

Part of my role as an expert in DM was to improve and standardise digital data, how, why and what is required in a clinical trial.

I am an active member of the ACDM, coordinating the online training being developed. prioritised and rolled out for people to attend via the ACDM website.
I enjoy being part of this DMEG firstly to share my knowledge and secondly to learn from others. Our vision was to share this with the wider community.

Oyiza Momoh
Clinical Data Manager
GSK

Cliona O’Donovan
Senior Statistician, Head of Irish Operations
Pavilion Health

My career in data management began in with a CRO the early 90s, initially working on paper-based studies and manual review of CRFs and listings. Over the years, I have moved with data management through RDE and EDC systems development, on studies ranging from small phase I to large multisite multilingual studies. I have worked in senior role in different parts of the world leading data management groups. While completing as master’s degree in epidemiology, I became interested in clinical audit and other sources of routinely collected health information and the data management of these areas compared to the tightly controlled clinical trial environment, particularly in terms of the challenges of reliable, accurate, traceable and timely data. In my current role I examine hospital activity data in terms of quality of data and how these data can inform decision making such as funding allocation and quality of care. I have been teaching clinical data management courses for the ACDM since 2008 and joined the ACDM eDigital team in 2019.

Nadia Petiot
QA Auditor & Data Management Expert
Focus Data Science

Marcus Schwabedissen
Chief Operation Officer, Senior Executive Consultant
QFINITY

Marcus has been in the life science industry for more than 20 years, and spent most of that time in IT, Computerised System Validation, Risk Management, Quality Management and Quality Assurance. Over the last 25 years he was in charge of different leadership positions, which included Head of Global Technology Quality Management and Head of the QA Computer Technology Auditing Group at PAREXEL. Marcus has a proven history of getting to the heart of matters impacting Quality or Information Security, with clear insight into gaps, threats and remediation solutions. Adept at leading worldwide programs and projects to deploy frameworks, systems, and controls that transform how companies handle risk prevention and mitigation. Recognized for driving continuous improvement at all levels, with a key focus on transformation in project management and systems controls including computerized system validation.

In October 2017, Marcus joined Q-FINITY, a consulting company for risk-based Quality Management, Quality Assurance, GxP-Compliance and Continuous Improvement of Processes, Data and Computerized System Validation. As Chief Operation Officer he now takes care of the operational belongings of Q-FINITY, but still regularly acts as advisor, consultant, trainer and auditor on all kinds of client projects.

Roxana Stain-Fedorovici
Clinical Data Team Leader
Signant Health

I joined Clinical Data Management when I started my role at Signant Health, 2.5 year ago, with a previous background in quality, training, human resources and project management. My work here, as a Clinical Data Team Leader is a medley between meeting sponsor expectations, the study teams or CRO’s requirements, the needs of the clinical sites and, most of all, making sure that the flow of data is uninterrupted between everyone involved.

Data Management, especially clinical, is not a dry environment, it’s ever-changing and demanding and, at the same time, extremely rewarding as I drive for success with every patient, study and customer.

Alan Yeomans
Quality Manager
Viedoc

Alan Yeomans has worked with the development of computerised systems for over 35 years as hardware designer, programmer, system architect, project manager and in a number of management roles including CTO and QM.

Alan has been Quality Manager for PCG Solutions since late 2008, where he is responsible for Quality Assurance of their EDC vendor business. From 2008-2014 he was also the Quality Manager for their CRO business before that part of the company was organised as a separate company. Alan has earlier worked as CTO for a Swedish CRO (CDC) and as CTO and QM for an international ePRO provider (Clinitrac).

Alan graduated with a Bachelor of Engineering (Electronics) from the University of Western Australia in 1980 and studied Control Systems at the Imperial College (London) in 1983. Alan worked at British Aerospace, Space and Communications Division from 1981 to 1984 as a hardware designer on control systems for communications satellites. While there he developed the first CPU-board used in control systems on their communications satellites. After moving to Sweden in 1984 Alan started working with software development, starting with hardware driver routines and moving up through the software architecture to all levels, including user interface software and database software.

Alan has worked with the use of electronic data in clinical research since 2000, and he has worked in the following international groups aimed at promoting the use of electronic data for clinical research:

  • EHRCR Project – EU Team Leader (internal eClinical Forum project)
  • EHR4CR Project – Member of User Scenario Task Team (EU project)
  • eSource Task Group – Technical Stream Team Leader (internal eClinical Forum project)
  • REG – Regulatory Expert Group – Co-chairman (internal eClinical Forum project)
  • NTWG – New Technologies Working Group – Chairman (internal EUCROF work group)
  • eDigital Team – member (internal ACDM group)

Alan is a member of RQA (the Research Quality Association), eCF (the eClinical Forum), EUCROF (the EU CRO Federation) and ACDM (the Association for Clinical Data Management).

 

 

Lauren Ellis-Hill (Chair)
Business Development Manager
Cytel

Hannah Bausch
Senior Clinical Research Professional
Esculape

Sverre Bengtsson
Co-founder
Viedoc

Alexandra Botezatu
Associate Director of Data Management
Signant Health

Jennifer Bradford
Head of Data Science
Phastar

Mariateresa Garcia
Senior Clinical Data Manager
Spanish Clinical Research Network

Vishal Kapoor
Group Manager, Clinical Data Sciences & Systems
Terumo

Tracey Lavery
Manager, Clinical Data Management
ONO Pharma UK ltd

Oyiza Momoh
Clinical Data Manager
GSK

Cliona O’Donovan
Senior Statistician, Head of Irish Operations
Pavilion Health

Nadia Petiot
QA Auditor & Data Management Expert
Focus Data Science

Marcus Schwabedissen
Chief Operation Officer, Senior Executive Consultant
QFINITY

Roxana Stain-Fedorovici
Clinical Data Team Leader
Signant Health

Alan Yeomans
Quality Manager
Viedoc