Audit Trail Review DMEG

Lauren is driven to make digital innovation more accessible to biotechs and pharma. With 14+ years’ experience in the life science industry, she uses her expertise in digital health and life science technology to deliver value for clinical trials. Specifically, she has developed the market for digital innovations in clinical trial design and recruitment forecasting, quantitative systems pharmacology (QSP) modelling and simulation, and electronic Patient Reported Outcomes (ePRO) / electronic Clinical Outcome Assessment (eCOA). She aims to improve the probability of success of clinical trials and stakeholder communication and engagement, as well as to drive new data insights.

She has Chaired the eDigital DMEG for ACDM over the last 4+ years, where she facilitates the co-creation of thought leadership content. She creates strong alliances and partnerships within the industry to share knowledge and to enable the exploration of digital innovations in healthcare and life sciences and evaluates its ability to facilitate meaningful improvements to clinical trials.

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 Viedoc Technologies 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).

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.

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.

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 is an early career Clinical Development Scientist, with an integrated Masters in Neuroscience from the University of Glasgow. Having worked in Study Management and Data Strategy & Management, Oyiza has a keen interest in the use of data and technology to benefit individuals and organisations throughout the clinical development process. She is passionate about optimising clinical trial methodology, increasing access to information and empowering others as the clinical trial landscape continues to evolve.

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.

I am Director 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.

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.

I am a Senior Lead Data Manager at PRA Health Sciences, working within our product registration division. I have been at the company for a total of five years, initially working as a Clinical Data Coordinator prior to moving into the role of Lead Data Manager. I have been heavily involved in operationalizing PRA’s Mobile Health Platform, supporting Biometrics and the wider business in integrating this technology into our clinical trials, ensuring data flow and collection are designed with a site-centric approach.

My experience outside of clinical research has been primarily within database administration & research analysis. My academic background is Psychology, initially receiving a Psychology degree, followed by a MSc in Research Methods within Psychology from Swansea University.

Nina Reyes (Manager, Clinical Data Management) is a certified nurse and graduated from the University of Bonn-Rhein-Sieg with a Bachelor of Science in Computer Science and Biomedical Informatics. For the last 16 years she has continuously worked in the Clinical Data Management area of various CROs with adding some experiences and skills to her portfolio with working as a Manager in the Start Up Operations and Country Management for Germany, Switzerland and Austria within one of the top 5 CROs.

Nina has always been interested in innovation and a smooth and swift implementation of it into the day-to-day work of Data Management. She is thrilled about the opportunity to be part of the ACDM eDigital DMEG and hopes to get a lot of new insights and to bring, together with the other members of this strong group, eDigital a step forward.

Andy has worked for 25+ years in the pharmaceutical and CRO sectors in senior management and consultant roles principally in data management.  A pharmacologist by original training he has worked both as a basic research scientist and in clinical research in the CRO sector.  Based in the UK his principal areas of interest are clinical trial operational efficiency and data standards. He has supported projects across all phases of the study lifecycle with particular emphasis on data management, statistical programming, standards (CDISC, FHIR), computer systems validation and systems implementation.  He is an active member of ACDM, RQA and PHUSE (where he co-leads the Emerging Trends and Technology workgroup), and contributes to the key performance indicators (KPI), the real-world evidence and FHIR projects.  He also is a tutor on the LSHTM Clinical Trials MSc.

An experienced technologist with over 30 years spent working with data across many different industry sectors across the globe.  For the last 11 years, Tim has been working exclusively in the Healthcare and Life Sciences domain providing strategic advice and architecting technical solutions to help customers manage the volume and diversity of data collected through healthcare encounters and clinical research.

Having worked with some of the leading Clinical Research software vendors Tim joined Medidata at the start of 2022 to manage and mentor the EMEAR Enterprise Solution Consulting Team.  The team provides support and guides our Enterprise customers as they discover and adopt The Medidata Clinical Cloud solutions.

Tim holds a Bachelor of Science degree in Applied Biology from University of Hertfordshire, UK and is currently studying for an MSc in Big Data and Data Analytics at the University of Liverpool, UK

Santosh Karthikeyan is a Certified Data Management Professional working as Technical Director in a leading Biopharmaceutical Company. He is involved in providing strategic, technical and operational leadership for Data and Analytics platform in R&D. He has led data science project on predicting adverse drug reactions in Life Sciences and managed teams in digital and analytics practice. He completed his Ph.D. in Management Studies from St. Peter’s Institute of Higher Education and Research. He holds Master’s degree in IT, Business Administration and Psychology. He has also completed Advanced Post Graduate Diploma in Clinical Research and Data Management. His research papers are published in various National and International journals. He has also participated in National and International conferences. His areas of specialization are Data Analytics, Data Science and AI, Cloud Computing, Change Management and Psychology. He is an active member of ACDM and Data Science Expert Group

Ioulietta works at Pivotal CRO, a full service oncology focussed CRO headquartered in Madrid, Spain in 2022. At Pivotal, Ioulietta manages the Biometrics team covering Data Management, Biostatistics and Database Programming as Executive Director, Biometrics.

Ioulietta is a statistician by background and has over the years worked with all different kinds of data. She has a long career working across a huge range of data systems and data warehouses, giving her a unique way of evaluating and selecting new technology systems benefits and risks.

Over the past 20 years, Ioulietta has worked across a range of industries, managing statistical, data management and software developer teams. Interesting projects she has been involved to date included leading the integration of banking customer platforms during the financial recession, developing a diagnostic test determining substance abuse for the London Olympics in 2012, as well as working on several clinical trials and indications – from ultra-rare diseases to large registry studies of more than 5000 patients.

Her career in the pharmaceutical industry started in 2001, as a Graduate Biostatistician enrolled on the first ever intake of Graduate trainees at PPD Development. Over time she worked in several small and large CROs, on a wide range of clinical trials with a particular interest in rare diseases and oncology studies.

Ioulietta holds a PhD and Masters in Medical Statistics from the University of Southampton.

Her research areas of interests are handling and managing missing data in clinical trials, risk based monitoring, decentralised trial technologies and developing successful vendor partnerships with specialist vendors to bring bespoke solutions to clinical trial implementation.

Natalia is a pharmacist by training and after 7 years of studies in the pharmaceutical field strongly oriented to the healthcare industrial environment, she has forged a strong educational profile in the healthcare ecosystem covering a great spectrum of innovative fields such as data science, immunotherapeutics, and genomics.

Furthermore, she has found herself, in a diverse and cross-functional professional environment. Specifically, she started her career as Associate in Corporate Strategy focused on pricing drivers, and substitution policies for hospital drugs. As a next step to her career path, she pursued a role in medical devices space, where she lead the development of decision-making applications for doctors, acting as a bridge between developers and the strategic marketing department in oncology. Currently, she holds a position as Senior Clinical Data Manager for Phase 3 clinical trials, where she has acquired solid knowledge on the sponsor perspective on clinical studies and has broadened her knowledge regarding clinical trial operations. On the top of that, she is engaging with the digitalized world for data integrity and validity and has gained considerable insight into the processes and complexities associated with the eConsent, digital recruitment, connected devices and personalized healthcare.

Natalia joined the eDigital Expert Group to actively contribute and support the development of a leading strategy and solutions to accelerate digital transformation across the healthcare spectrum. Providing input from an operational standpoint and focusing on improving customer/patient experiences through business solutions, incorporating for example, blockchain, Machine Learning and AI models.

Peter is currently Associate Manager within Clinical Data Sciences department as well as Country Lead of Slovakian office in Premier Research. He has 7 years industry experience all spent in CRO as well as 6 years of experience as Scientist/Researcher in Slovakian Academy of Sciences. Peter is leading team of experienced Data Scientists and Data Coordinators in data management group as well as being part of DM Management team, focused on process improvements, business operations related to DM and direct cooperation with the clients on specific projects. Being one of the founding members as well as long term leader of the internal learning academy focused on the knowledge and skillset improvement of junior roles in data management department, helped Peter improve many of his skillsets especially in the managerial role. Except the role in data management, Peter has also become Country Lead of the Premier Research Slovakian office, supporting  70+ employees.

I am a Senior Data Manager at Labcorp Drug Development, with 3 years’ industry experience in data management at CRO’s, before this I was introduced to the world of data management through a year in employment as part of my degree in Biomedical Sciences at the University of Southampton.

Having recently worked on decentralised and hybrid studies utilising lots of new processes and technology I have joined the eDigital Expert Group to learn more and share my experiences to allow the development of strategies and approaches to these new technologies to enhance the transformation whilst always ensure the best patient experience.

Doug Bain has worked in the clinical research technology field for over 25 years. During this period he has both developed and implemented EDC, CTMS and Hybrid DCT solutions for companies including IBM, Medidata and eClinicalHealth (Clinpal). Doug is currently the Chief Technology Officer at KCR – a mid sized global CRO – where he leads the Technology & Innovation department.

Alberto is a Data Scientist with experience in in-house and freelance settings and a solid background in Clinical Research. He successfully handled data management activities in phase I – phase III multi-centered clinical trials, in Oncology and Rare Diseases studies from start-up to close-out. Alberto is results-driven and team-oriented, with a proven ability to develop processes to improve operational efficiencies and successfully widen initiatives through purpose-led collaboration.