Nadir Ammour

Sanofi R&D

Nadir is as an oral surgeon and worked first, in public healthcare. He holds a university degree in health economics and medical informatics. He has served in global positions at Wyeth, and now at Sanofi, in clinical operations, leading projects in clinical development, and clinical technologies. Nadir is actively engaged in bringing innovation in clinical development and led projects in remote trial (Verkko), wearables trials, digital endpoints trials and recently in EHRs driven clinical trials. He is a member of the Executive Committee of the EHR4CR champion project. Nadir is presently leading a consortium project EHR2EDC aiming at further developing capabilities to conduct trials using EHRs data directly.

Adam Baumgart

Covance

Adam has spent 29 years in clinical research and has been with Covance for 10 years. With job roles in pharma, an EDC vendor and several major CROs, he is experienced in risk-based monitoring, process excellence, project management, clinical data management and clinical monitoring.

Adam’s role is Senior Director, Xcellerate Monitoring Solutions Development in Covance’s risk based monitoring (RBM) and central monitoring organization. He leads the cross-functional, transformational project team responsible for the implementation of RBM, central monitoring and risk management tools, processes, roles and services. Adam is passionate about the opportunity these capabilities bring to the way we work, our roles and the improvements in data integrity, patient safety and regulatory compliance.

Stephen Brown

Roche

Stéphane Chollet

Keyrus Biopharma

Stéphane Chollet is an experienced Senior Project Manager who joined the Pharmaceutical R&D industry in 2004, moving to Keyrus Biopharma in 2005. He has experience working in institutions (French Petroleum institute), in small and mid-size CRO (Therapharm Recherches and Keyrus Biopharma), acting in the Data Management field. Stéphane is currently leading the Innovative Technology Initiative, a working group dedicated to the development of innovative tools for biopharma companies.

During his career in Data Management, Stéphane has been the successful leader of the data management functional service platform for GSK Vaccines, following the international flu pandemic alert in 2009. Showing excellence and efficiency during all phases of the collaboration from set-up to conduct, Stéphane was key in expanding our collaboration with GSK, leading to several other FSPs implementation.

Stéphane is a bachelor in Biology of Populations and Ecosystems and hold a master degree in Management of Data for Biomedical Research.

Rich Davies

OmniComm

Richard Davies joined OmniComm in February 2014 and is based in the UK. As Executive Director of Business Solutions his role is to support organizations’ adopting OmniComm solutions from a technical, functional and business process perspective, particularly as they execute their vendor selection programs. Additionally he has product management responsibilities and provides a bridge between customers, prospects and ongoing product development. He has worked for technology vendors for nearly 20 years but prior to this, he worked in data management with Fisons Pharmaceuticals and Astra.

Fabien Didier

Sanofi R&D

Fabien Didier holds a university degree in Cellular & Molecular Biology as well as in Computer Sciences applied to Life Sciences. He has spent 25 years in clinical research with various positions in Data Management in different therapeutic areas. During this period, Fabien managed a global team, experienced several operating models, developed standards and was involved in some submissions.

In 2010, Fabien joined a Transversal expert team and worked in projects such as the implementation of a new Data Management partnership model with an Indian company, the KPIs, the Clinical Data Management System selection, the data validation strategy & dashboard, the resource algorithm definition….

Currently, Fabien is leading a Data Management expert team dedicated to the Data Management, the DM sourcing models, the standards & the technologies. He is also engaged in bringing innovations in Sanofi clinical trials.

Xavier Gobert

MyData-Trust

Xavier Gobert, CEO of MyData-Trust has over 20 years’ experience in the Pharmaceutical Industry. He is deeply passionate about delivering exceptional service. Xavier is also a clinical data standards expert leading the French Users Group of CDISC since 2011 and board member of the E3C.

Malin Jakobsson

Uppsala Monitoring Centre (UMC)

Malin is Product Strategy Manager for WHODrug dictionary at Uppsala Monitoring Centre (UMC). She is a pharmacist by training and she has been working with WHODrug in different roles for twelve years, from data validation to production and now she is involved in the strategic development of the WHODrug offering. She has been running projects such as the development of the Standardised Drug Queries, the development and introduction of the new dictionary formats and new dictionary type. She is involved in collaborations with US FDA, Japanese PMDA and several other authorities. She is also involved in the ISO group and EU task force for the implementation of the Identification of Medicinal Products, IDMP. Malin is passionate for development of products that make life easier for its users and she always encourages and welcomes input for new developments of UMC offerings

Dipak Kalra

European Institute for Innovation through Health Data and of the EuroRec Institute

Dipak Kalra, PhD, FRCGP, FBCS, is President of the European Institute for Innovation through Health Data and of the EuroRec Institute. He plays a leading international role in research and development of electronic health record interoperability standards, data and privacy protection, interoperability business models and the reuse of EHRs for research. He has led multiple European projects in these areas, including Horizon 2020 and the IMI programme alongside pharma companies, hospitals and ICT companies.  Dipak is Clinical Professor of Health Informatics at University College London, visiting professor at the University of Gent, and a member of standards bodies including CEN, ISO and HL7.

Bertrand Le Bourgeois

Silicon Marketing / PharMarketing

Bertrand Le Bourgeois MSc, Dipl. Ing. graduated as an engineer from Ecole Centrale in France, with a marketing specialisation from HEC Business School. He has spent his career in Management and IT Consulting, in the healthcare and life science industries at major software solution providers for Clinical Research and Data Management.

Now Bertrand runs Silicon Marketing and PharMarketing, two business development and marketing consultancies, dedicated at helping companies develop in the pharmaceutical sector in EMEA. He is speaking regularly at industry conferences in Europe and US, and sits at the Board of Data Management Biomedical and Association for Clinical Data Management.

Marketa Mannering

CROS NT

Marketa has been working in the field of Data Management in the CRO environment since 2007 when she began her career as a Data Manager and Data Entry Clerk. In 2012, she became Manager of Clinical Data Operations for MDSL International in the United Kingdom, a position which she held until the company was acquired by CROS NT in 2013. Marketa then became a Principal Data Manager for global CRO.

She has been the Lead Data Manager on numerous studies and has participated in many kick-off meetings, bid defense meetings and client training. She has an in depth understanding of clinical data management processes from protocol review to database lock. She has extensive knowledge across a number of therapeutic areas. Marketa joined the ACDM conference committee in 2014.

Jean-Luc Marsat

AEC-Partners

Graduating as a bio-engineer from the Ecole Nationale Supérieure d’Agronomie et des Industries Alimentaires (ENSAIA) and followed with an executive MBA from HEC Paris, Jean-Luc has worked in Clinical Research as Worldwide Managing Director of SGS Clinical Research, European Director of MDS Pharma Services and Strategy Consultant at Arthur D. Little. During these experiences, he has led international teams of up to 500 people.

Recently, Jean-Luc joined AEC-Partners a strategic consulting firm specialised in healthcare. He leads assignments for the pharmaceutical companies to optimize their R&D strategy and supports CROs in putting in place innovative projects. Jean-Luc has established a solid international network within the pharmaceutical sector and with CRO companies, which he has leveraged to support private equity funds as a Senior Advisor.

Earlier in this career, Jean-Luc worked for 13 years with Essilor as a General Manager and a Marketing Director in several European countries

Jo Marshall

CROS NT Limited

Jo started her career as a Data Manager in Searle back in the 1990’s, where she developed to a high level global data manager role, with particular expertise in new technologies and process improvement. This is also where her career in the ACDM began as part of the website sub-committee and gaining the MSC in Clinical Data Management that the ACDM set up in conjunction with Kingston University. After several mergers and acquisitions Jo left the pharmaceutical company side of the industry and started working with an Entrepreneur in a start-up CRO. Together they grew the company, developing a reputation for quality and expertise in Biometrics and Jo became the Managing Director of MDSL International after 5 years broadening her data management experience into strategic management. In 2013 CROS NT acquired MDSL International and Jo became the UK Country Manager for the global CRO. She has worked on a number of special projects while maintaining her strategic management responsibilities, including Integration, Quality Management Systems, Continuous Improvement, Functional Service Provision, HR, Business Development. Jo joined the ACDM conference committee in 2010, became chair in 2014 and also joined the ACDM board in 2014 as Treasurer.

Ian Pinto

Roche Products Limited

Dr. Johann Pröve

Past Global Head Data Management, Bayer Healthcare

Dr Johann Pröve studied agro-biology and started his business life in 1980 at Bayer in Clinical Data Management. Between 1990 and 1994 he was Head of Clinical Data Management at Bayer Corp in West Haven, Connecticut, USA.

Since 2000 Johann was the Head Global Data Management at Bayer Healthcare until November 2013 when he was appointed as Global Strategy and Development Advisor in Global Data Sciences and Analytics.

As of Jan 1 2016, Johann offers clinical data management consulting services as a freelance consultant and is also the Chief Scientific Officer at Cyntegrity, an RBM application company.

Andy Richardson

d-Wise

Andy Richardson has worked in the pharmaceutical and allied industries for more than 25 years.  Trained originally in pharmacology, he has worked in both the pharma and CRO sectors for top 10 pharma and leading CROs where he has held senior roles in clinical data management and clinical systems as well as working independently in QA, project team leadership roles and supporting and delivering MSc and other training courses.  He is currently a consultant with d-Wise based in the UK, supporting major clinical systems reengineering and process improvement initiatives for pharma with a primary focus on CDISC standards operational implementation across the study lifecycle.

Marcus Schwabedissen

Q-FINITY Quality Management

Marcus has been in the life science industry for more than 20 years, and spent most of that time in IT, Project Management, Technology Quality Management and Assurance. He started his career at a CRO, PAREXEL, where he worked three years as a IS Supervisor and was responsible for IT operation for multiple offices, as well as several IT projects including several roll-outs and the Year-2k project. In 2000 he moved to the University Hospital of Heidelberg and became the Head of IT and Computerized System Validation at the Coordination Centre for Clinical Trials, an academic CRO at the University Hospital of Heidelberg.  In this role he introduced state of the art computerized system validation and management practices to an academic environment. He initiated and implemented the first regulatory compliant EDC solution for the support of multi-centric-trials at the University Hospital. Three years later he re-join PAREXEL in a Quality Manager position. Over the last 14 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. Marcus has a proven history of getting to the heart of matters impacting IT security and risk, 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. Recently, he joined Q-FINITY, a consulting company for risk-based Quality Management, Quality Assurance, GxP-Compliance and Continuous Improvement of Processes, Data and Computerized Systems. As Chief Operation Officer he now takes care of the operational belongings of Q-FINITY.

Jon Wood

Accelsiors

Jon has 27 years of industry experience in biometrics services in both Pharma & CRO organizations. He lead global data management and biostatistics teams in serving Accelsiors’ Customers. Jon has extensive knowledge across a number of therapeutic areas. He is a recognized expert in data management and serves as the co-Chair of the Association for Clinical Data Management and is an accredited trainer. Jon has previously held leadership positions with GSK, Pfizer and Amgen.

Brookwood

Sponsor Type: Headline Sponsor

Brookwood is in its 32nd year and is well known as a provider of global clinical research training, both online and face to face. At this conference we will be showcasing our brand new online, on demand data management training module together with our new book, A Guide to GCP for Clinical Data Management. The book and training cover the key ICH GCP E6(R2) requirements relevant to members of the data management team. They also provides valuable practical advice gained from the author’s extensive experience in this field. Come and see us and find out more at our exhibition stand. You can even ask for online access to evaluate the course.

Brookwood’s well known online narrated Essential GCP training for both sponsors and investigators  is available in 11 languages – it meets TransCelerate minimum requirements for the mutual recognition of GCP training for investigators and has been passed by over 30,000 users globally.

Canary specialises in producing books, newsletters and teaching aids to facilitate global regulatory compliance, particularly good clinical practice (GCP) and Pharmacovigilance (PV).

E: info@brookoodacademy.org
W: http://www.brookwoodacademy.org

EDGE

Sponsor Type: Headline Sponsor

EDGE provides an innovative cloud-based clinical management system that empowers frontline clinicians to make the most of their research data. EDGE is specifically designed to give a real-time view of clinical research activity within a single hospital or network within the UK, Canada and beyond. EDGE was developed by the Clinical Informatics Research Unit (CIRU) within the Faculty of Medicine at the University of Southampton. CIRU operates as an applied research and enterprise unit working nationally and internationally with the core aim and vision to transform clinical research and practice through novel approaches to information and software management.

E: Twitter: @EDGEclinical
W: http://www.edgeclinical.com

Excelya

Sponsor Type: Headline Sponsor

Excelya is a Contract Research Organisation (CRO) that provides services for biotechnology  and pharmaceutical companies,  medical devices and cosmetics firms. Our scope of intervention concerns trials from Phases I to IV. We are working for most of the ten top largest pharmaceutical companies in the world. At Excelya, we do consider that retaining our employees ensures their professional development and provides the best service level to our clients. These are key factors for our success, and our company values.

E: fpaqueville@excelya.com
W: http://www.excelya.com/

Keyrus Biopharma

Sponsor Type: Headline Sponsor

Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

E: Nicolas.Leroy@Keyrus.com
W: http://www.keyrusbiopharma.com/

Manchester Academic Health Science Centre, Clinical Trials Co-ordination Unit (MAHSC CTU)

Sponsor Type: Other Sponsor: Notebook Sponsor

The MAHSC Clinical Trials Unit (MAHSC-CTU) is an essential core resource for clinical and academic investigators and provides a wide range of services supporting the conduct of investigator-initiated clinical trials across Greater Manchester, the North West and the UK.

E: MAHSCCTUSupportRequests@christie.nhs.uk
W: http://www.mahsc.ac.uk/

Brookwood

Brookwood is in its 32nd year and is well known as a provider of global clinical research training, both online and face to face. At this conference we will be showcasing our brand new online, on demand data management training module together with our new book, A Guide to GCP for Clinical Data Management. The book and training cover the key ICH GCP E6(R2) requirements relevant to members of the data management team. They also provides valuable practical advice gained from the author’s extensive experience in this field. Come and see us and find out more at our exhibition stand. You can even ask for online access to evaluate the course.

Brookwood’s well known online narrated Essential GCP training for both sponsors and investigators  is available in 11 languages – it meets TransCelerate minimum requirements for the mutual recognition of GCP training for investigators and has been passed by over 30,000 users globally.

Canary specialises in producing books, newsletters and teaching aids to facilitate global regulatory compliance, particularly good clinical practice (GCP) and Pharmacovigilance (PV).

E: info@brookoodacademy.org
W: http://www.brookwoodacademy.org

Find us at Stand Number: 1

PRA Health Sciences

PRA Health Sciences is an award winning CRO.

We are proud to have won Pharma Times ‘Clinical Research Company of the Year’ in 2017 for the fourth consecutive year. We aren’t winning these awards by chance; PRA is being recognised industry-wide for our dedication to the future of clinical development. Most importantly for you, at PRA we recognise that our success is down to our people.

At PRA, we don’t make our 15000+ people great. It’s the other way around. As we have grown to a top-5 CRO, we have maintained the feel of a small company, dedicated to collaboration and passion for what we do.  We always have a desire to keep seeking new and better ways to operate. We don’t settle for the same old ways. Our passion for improving patient lives worldwide permeates all that we do. Put simply, we care.

E: walshamjames@prahs.com
W: https://prahs.com/

Find us at Stand Number: 3

IDDI

IDDI IS YOUR BIOSTATISTICAL AND INTEGRATED eCLINICAL SERVICE PROVIDER ENSURING CLINICAL DATA READY FOR SUBMISSION, OFFERING TRIAL DESIGN – RANDOMIZATION – DATA MANAGEMENT AND BIOSTATISTICS

Established for more than 26 years, IDDI (International Drug Development Institute) provides quality clinical data ready for submission, thanks to a unique combination of methodological excellence and operational efficiency.

DATA MANAGEMENT SERVICES:

Increase efficiency and mitigate risks throughout your clinical development by using IDDI, your CDISC Registered Solutions Provider.

• COMPREHENSIVE DATA MANAGEMENT SOLUTIONS
• eCRF DEVELOPED TO CDASH
• CDISC STANDARDIZATION (SDTM-ADaM)
• POOLING FOR ISS/ISE – SCS/SCE

IDDI has a broad expertise in various therapeutic areas and a special focus in oncology, ophthalmology, CNS, metabolic, cardiovascular, auto-immune, infectious diseases and rare diseases.

Our experience spans 26+ years with 900+ trials and 17 FDA/EMA approvals to-date.

IDDI is based in Belgium – EU, with offices in Cambridge MA, Raleigh NC, San Francisco CA, USA. .

E: catherine.indekeu@iddi.com
W: http://www.iddi.com

Find us at Stand Number: 2

Viedoc

Viedoc by PCG Solutions is a global EDC and ePRO vendor with offices in Sweden (Uppsala), Japan (Tokyo) and China (Shanghai). Viedoc is a modern and future-proof EDC that allows clinical trial sponsors and study sites to easily and securely collect, validate, transmit and analyze clinical study data.  

Viedoc is a proven software since 2003 which meets or surpasses all regulatory benchmarks. Designed to be as intuitive as possible, Viedoc saves time and frustration from users at every level, allowing clinical trial organizations to have more focus on their own innovation and leadership.

E: henrik@viedoc.com
W: http://www.viedoc.com

Find us at Stand Number: 4

Keyrus Biopharma

Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

E: Nicolas.Leroy@Keyrus.com
W: http://www.keyrusbiopharma.com

Find us at Stand Number: 5

Excelya

Excelya is a Contract Research Organisation (CRO) that provides services for biotechnology  and pharmaceutical companies,  medical devices and cosmetics firms. Our scope of intervention concerns trials from Phases I to IV. We are working for most of the ten top largest pharmaceutical companies in the world. At Excelya, we do consider that retaining our employees ensures their professional development and provides the best service level to our clients. These are key factors for our success, and our company values.

E: fpaqueville@excelya.com
W: http://www.excelya.com/

Find us at Stand Number: 6

EDGE

EDGE provides an innovative cloud-based clinical management system that empowers frontline clinicians to make the most of their research data. EDGE is specifically designed to give a real-time view of clinical research activity within a single hospital or network within the UK, Canada and beyond. EDGE was developed by the Clinical Informatics Research Unit (CIRU) within the Faculty of Medicine at the University of Southampton. CIRU operates as an applied research and enterprise unit working nationally and internationally with the core aim and vision to transform clinical research and practice through novel approaches to information and software management.

E: Twitter: @EDGEclinical
W: http://www.edgeclinical.com

Find us at Stand Number: 7

Phastar

PHASTAR is a specialist CRO offering statistical consulting and clinical trial reporting services to the pharmaceutical industry. Our number one priority is to ensure the work we produce is of the highest quality: every project PHASTAR undertakes is supervised on methodology and utilises unique internal processes designed to ensure the best quality. Our aim is to provide a service that is ahead of our competitors: in the last 2 years, we have been involved in the design and reporting of over 200 studies, and each has delivered on-time and with no quality issues. We can provide data collection as a MEDRIO partner. Talk to us about using MEDRIO for your study – MEDRIO is fully functional, easy to use, and sensibly priced.

E: sarah.mccabe@phastar.com
W: http://www.phastar.com/

Find us at Stand Number: 8

CluePoints

CluePoints® is a Risk-Based Monitoring and Central Statistical Monitoring solution that has been designed and perfected over the last 15 years. It employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the ICH, FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring, medical review and to drive a Risk-Based Monitoring strategy.

E: contact@cluepoints.com
W: http://www.cluepoints.com

Find us at Stand Number: 10

Quanticate

Quanticate is a leading global Data-focused Clinical Research Organization (CRO) primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance. As Experts in Clinical Data, Quanticate provides high quality teams that offer efficient outsourcing solutions for clinical data management, biostatistics, SAS programming, statistical monitoring medical writing and pharmacovigilance.  Quanticate can offer study level support, functional service provision (FSP), strategic full data-services solutions or technical consultancy to meet the needs of pharmaceutical, biotechnology and device companies across the globe.  By offering high quality, value-add client specific solutions to meet current and future development needs, Quanticate has become the supplier of choice for many companies from Top tier pharmaceutical giants through to niche biotechnology and device companies

E: enquiries@quanticate.com
W: http://www.quanticate.com/

Find us at Stand Number: 9

Arithmos srl

Arithmos is an ISO 9001 and ISO 270001 certified IT company focused on Life Sciences industry.

Our solutions support multiple clinical trial processes enhancing efficiency and global alignment:

• Electronic Data Capture: Symphony EDC is an intuitive SaaS EDC solution designed by investigators and developed by Arithmos to allow a quick and autonomous study set up and management, fully in compliance with international standards;
• Clinical Trial Management: SYNClevy is and Extended Project and Portfolio Management system developed to support clinical project managers in their daily activities’ planning and management, increasing collaboration among all company’s departments and enhancing Clinical Trial Oversight, as required by ICH GCP E6(R2);
• Pharmacovigilance: Argus Blueprint is a pre-configured, fully validated pharmacovigilance platform for the fast deployment of Argus Blueprint.

Come meet our experts at Arithmos Booth

E: info@arithmostech.com
W: http://www.arithmostech.com

Find us at Stand Number: 11

Castor EDC

Castor EDC is making medical research faster and smarter with their user-friendly data capture platform. They provide a mobile-friendly EDC for clinical trials, built by researchers, for researchers. Features include self service eCRF creation (form building), randomization, ePro (patient surveys), monitoring, easy import and export of data, EHR data importer (HL7 FHIR based), audit trails, user management, and much more. We are fully ISO 27001 certified, GCP, 21 CFR & GDPR compliant and provide servers in the US (HIPAA compliant), the Netherlands and the United Kingdom.

E: support@castoredc.com
W: http://www.castoredc.com

Find us at Stand Number: 12