Helen is the Vice President of the Clinical Outcomes Assessment (COA) team at Clarivate – a healthcare research and analytics company. Helen has 15 years of experience developing patient-reported outcomes (PROs) and other COAs for clinical trials in line with regulatory (FDA, EMA) requirements. Helen has developed and validated multiple COAs for clinical trials and clinical practice. She specialises in COA reviews according to regulatory (FDA/EMA) requirements and qualitative research methods using creative, patient-centred techniques. Helen has conducted concept elicitation and cognitive debriefing interviews with patients and clinicians in multiple therapy areas with extensive experience in women’s health and dermatology. Helen is an active member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society of Quality of Life (ISOQOL) and is a specialist trainer in qualitative interviewing skills, mixed methods research and PROs for HTA/reimbursement.

Ramota Alaran is an epidemiologist and real-world scientist with experience working with CROs. She has extensive experience in teaching and delivering seminars related to epidemiology and public and global health. Ramota is well-versed in RWE project development, stakeholder development & building client relationships. Ramota is the Associate Director of RWE at Cisiv. Cisiv is a technology company specialising in real-world data/late-phase research.

Rebecca Crawford is a Director of Patient-Centered Outcomes Assessment at RTI Health Solutions, a nonprofit research organisation providing consultancy to global biopharmaceutical companies. Ms. Crawford has a background in anthropology and 15 years of experience incorporating the patient voice into the drug development process. She has significant expertise in conducting social media research to explore unsolicited insights into the patient disease experience. Ms. Crawford is at the cutting edge of exploring the value of SM data as a research area in its own right, and as a complement to traditional qualitative research, to provide a holistic view of the lived experience of disease.

Tom is a People & Product Leader in Data Sciences at Roche. He is also a Chapter Head for Strategy & Implementation in the Patient-Centred Outcomes Research Evidence group. Since joining Roche eight years ago, Tom has worked across the end-to-end drug development cycle with a particular focus on developing and validating clinical outcome assessments for neuroscience and rare diseases. Prior to joining Roche, Tom held roles within academia, clinical practice and consulting. Throughout its 125-year history, Roche has grown into one of the world’s largest biotech companies. Over 28 million patients are treated with Roche products each year.

Mark P. Wade is Global Practice Leader at TransPerfect Life Sciences, where he is the resident SME for all clinical trial processes and translation. Mr. Wade’s 20 years in life sciences include roles such as International Regional Director for EMEA at Ethicon and Ethicon Endo-Surgery, a Johnson & Johnson company. For almost 10 years, Mr. Wade was Global Practice Leader at another global language translation company. He is a published expert in electronic clinical outcomes assessments (eCOA), including two eBooks, clinical posters and numerous articles in trade journals. He has significant experience and has published in clinical services, patient recruitment and site selection. Mr. Wade has chaired, presented and published posters at DIA Annual Symposia and numerous other internationally recognised conferences. He is an active committee member of the ISOQOL Translation & Cultural Adaptation (TCA) special interest group (SIG), ISPOR TCA SIG and DIA Endpoint Study Group.

Sherif is Regional Medical Lead-Enzyme Replacement Therapies (ERTs) for BioMarin and has more than 18 years of industry experience (within four multinational research-based pharmaceutical companies) in commercial and medical affairs functions.  and a solid track record of successful Medical Affairs projects through cross-geographical intercontinental regions. Sherif is a clinical pharmacist by training, awarded an M.Sc. degree with distinction from the Queen’s University Belfast & a Master of Applied Research (MOAR) in business administration from Swiss Business School. Sherif also holds a pharmaceutical medicine diploma from Merck & Co and a Principles and Practice of Clinical Research (PPCR) certificate from the Harvard T.H. Chan School of Public Health. Currently, Sherif is studying for his doctorate in business administration (DBA) at Swiss Business School. Sherif possesses diversified experience in multiple therapeutic areas, including cardiometabolic, infectious & rare diseases. Sherif worked closely with local & global key scientific leaders in various projects that supported both the medical community and the industry’s vision. Through his work, Sherif is helping patients across various countries enjoy a better quality of life by supporting HCPs in making informed choices that improve their patients’ outcomes.

Bringing over two decades of experience, Sridevi Nagarajan is a seasoned strategic portfolio management professional deeply rooted in data-driven approaches. Her expertise lies in successfully steering digital transformations within the pharmaceutical and public health sectors. She is a collaborative innovator who thrives on cultivating relationships and leveraging data to guide corporations through dynamic business transformations. A motivated and influential leader, she is equipped with advanced analytical skills and a wealth of knowledge spanning drug development, clinical operations, regulatory affairs, data analytics & AI, digital initiatives, information management and governance. Demonstrating a consistent track record of surpassing goals, her specialisation lies in driving business benefits through simplification and tech transformation programmes. As an influencer and change leader, effective collaboration with various stakeholders, including government entities, academic institutions and industry partners, has led to significant organisational growth.

Umar is a graduate of the University of Iowa (US) and has a Bachelor of Science in biology and computer science. He received his master’s in healthcare informatics from the UK. Umar has also attained certifications in PMP and Six Sigma. In 2019, Umar was awarded the “Top 100 Healthcare Leaders” award by the International Forum on Advancements in Healthcare (IFAH). Currently, Umar leads digital transformation globally, advocating for the use of innovation. The Digital Transformation team serves as the “brain” for Digital Health Solutions by formalising strategies, commercialisation, product analysis, value realisation and end-to-end delivery.

Michaela is a bright, fast-paced, environment-savvy, plug-and-start Senior Regulatory Affairs leader, with over 16 years of industry experience in Global and European Union Regulatory Affairs, spanning big pharma and startups. She possesses extensive expertise in therapeutic areas from early to late-stage development. As an independent Head of RA, Nahler meticulously strategises regulatory plans to propel the drug development programmes of numerous smaller companies forward.

During her tenure at Urovant, Michaela played a pivotal role in establishing and spearheading the European Union RA function, overseeing Marketing Authorisation Applications (MAAs) for the company’s priority programme. Additionally, she was instrumental in securing an out-licensing partnership deal, showcasing her indispensable contributions to the company’s strategic objectives. Michaela holds a Master of Science in Regulatory Affairs, a Bachelor of Science and an advanced Master’s.

Professor Schelter, CEO of GTDiagnostics (UK) Ltd and Chief Analytics Officer of TauRx Therapeutics, is also affiliated with the University of Aberdeen as Professor for Applied Mathematics. Relying on more than 20 years of experience in the health care sector, he led research teams since 2006. The focus of his work is on developing data-science based technologies to advance understanding of diseases and ultimately help millions of patients. GTDiagnostics develops readily deployable e-platform tools that range from interactive well-being apps that can be used at home to comprehensive tools for expert use targeting the diagnosis and monitoring of dementia.

Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. He brings over 25 years of product management, consulting and engineering experience across verticals such as life sciences, enterprise software, healthcare, government, entertainment and manufacturing. Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding and Grants solutions. Jay has also created and managed products for eCTD submission publishing and review, enterprise quality management, document management, computer validation and mobile apps for physicians, sales reps and music and sports fans. Jay holds an MBA from Villanova University and a degree in computer science and physics from Gettysburg College.

Marjaana Ahvenlammi-Sieppi has worked in the pharmaceutical industry within drug Regulatory Affairs addressing post-marketing issues since 2003. Marjaana brings extensive MA maintenance experience from consultant companies, the generic industry, and originator pharma companies. Marjaana works for Santen Oy, a 130-year-old ophthalmology company, and joined Santen EMEA RA in January 2018. In her role, she serves as the regional regulatory lead for the maintenance activities of certain dedicated products. Marjaana works as a Labelling Expert in the EU area, coordinating Readability user tests, Braille, PI WIs, and bi-weekly meetings with Artwork Management and consultants.

Nicola Squillacciotti is a regulatory professional with over 20 years of experience in the pharmaceutical industry. Nicola has worked with vaccines, branded and generic products, orphan drugs and gene therapy following the registration in Europe and globally. His primary responsibility is product labelling.

Pierre-Frédéric Omnes, Executive Director at TransPerfect Life Sciences, has over 20 years of experience in global CROs and pharma companies as a regulatory affairs consultant overseeing numerous multinational clinical trial applications globally. Pierre is a subject-matter expert on site startup and regulatory operations in global clinical trials as well as on the EU Clinical Trial Regulation 536/2014 (EU CTR) for corporate readiness, implementation and Clinical Trial Information Systems. Pierre is part of the EMA-led initiative developing the EU Clinical Trial Information System (CTIS) as Lead Product Owner. Representing industry & academia since 2019, he is continuing an engagement of several years in user acceptance testings, workshops and analysis & design sessions related to CTIS development and optimisation.

Dr. Tobias Kruse is a renowned expert in the clinical trial industry, with extensive experience in patient recruitment. He is the driving force behind Trials24, a cutting-edge company that specialises in accelerating patient recruitment for biopharmaceutical companies and Contract Research Organizations (CROs). By employing a scientific approach and tailor-made patient recruitment solutions, Trials24 de-risks and expedites the clinical trial process, ultimately enabling innovative drugs to reach patients faster. Under Dr. Kruse’s leadership, Trials24 has become a trusted partner for organizations seeking to streamline their clinical trials and make a significant impact in the healthcare sector.

Aman Khera, aka Rebel Regulator at Worldwide Clinical Trials, has nearly three decades of experience in life sciences clinical research, advising biotech and pharma companies. With a deep foundation in global regulatory affairs and the life sciences industry, Aman looks at how regulatory, strategy and innovation intersect within healthcare. She is a 2021 PharmaVOICE 100 honoree, recognised as one of the most influential and inspiring people in the life sciences industry. An advisor, board member and mentor in industry, and most importantly as a family member of the care circle for a pediatric rare disease patient, her passion extends beyond just work.

Georgia Hardy is the Associate Director, Site Enrolment Optimisation at Innovative Trials, leading the patient recruitment & retention team. Georgia has also worked for a prominent global pharmaceutical company. Working in over 70 countries, Innovative Trials supports the biggest pharmaceutical, CRO and biotech companies through its unique ‘boots on the ground’ approach to patient recruitment and retention.

Monica Hadi, Ph.D., is a Senior Director with the patient-centered research group at Evidera, based in London. Dr. Hadi is a scientist with more than 15 years of experience in the patient-centered outcomes field. She has extensive experience in the development and validation of clinical outcome assessments (COAs) and the design and implementation of COA endpoint strategies in clinical development programmes. She also has specific expertise in real-world data studies and registry study design. Monica holds a Ph.D. in evidence-based medicine and health outcomes from The University of Oxford and an MSc in health psychology from University College London.

Dr Sonya Miller, Head of Medical Affairs at TauRx Therapeutics, oversees all aspects of patient safety in the global clinical trials and ongoing expanded access programmes. She also serves as the Chief Medical Officer for sister company, GTDiagnostics, as they take a holistic approach to developing both treatments and intelligent psychometric tools to change the pathway for people with AD and related disorders.

Previously a Consultant Anaesthetist, Dr Miller shifted her focus to research in neurodegeneration, specifically Alzheimer’s disease with TauRx focusing on the role of Tau proteins.

Leanne Woehlke is a Director of Life Sciences Solutions at TransPerfect where she helps clients create transformational impact with language, technology and business consulting solutions. She has extensive experience in clinical research and knowledge of digital marketing. Her considerable coaching background allows her to bring a unique perspective to patient recruitment and engagement. She is passionate about impacting the industry in meaningful ways and bringing life-changing treatments to patients who need them.

Henry joined Trial Interactive in 2019 after a decade in the CRO and, before that, pharmacovigilance space. As part of our EU Trial Interactive team, he takes the lead on all UK and Ireland client support and has unique experience in advising academic and government-funded sponsors in TMF best practices.

More recently, he has specialised in guiding “greener” clinical teams in future-proofing clinical document management in team configuration, SOP best practices, eClinical platform selection and outsourced TMF resource management.

Gill Gittens has 25+ years of TMF-focused experience. Currently, she is the Director of eClinical Strategy and Solutions for TransPerfect Life Sciences. She has a wealth of valuable expertise in strategic account management, operations, eTMF implementation and the ongoing customer success of global eTMF solutions. She is a current member of the CDISC TMF Reference Model Steering Committee and was the co-chair of the Quality Team for the DIA Framework for Paper Destruction Initiative. She is currently working with her industry colleagues to revise the TMF Plan template provided by the Reference Model.

She has a love for writing and has authored several published TMF-related blogs and whitepapers as well as articles in recognised industry journals.

Avani joined Trial Interactive in 2018 after 10.5 years at an eTMF vendor. Initially part of the Project Management team for four years, Avani worked as an Executive Project Manager, where she was responsible for system implementation, best practice guidance and ongoing customer success for TI’s largest clients. With more than 15 years of clinical industry experience, Avani has now made the move into TMF consulting, helping clients with industry best practices, eTMF and CTMS systems best practices, business process development and SOP/TMF plan creation.

Sylwia Matuszewska, TMF Manager at Shionogi Europe, began her journey in the pharmaceutical industry nearly a decade ago, starting as a Clinical Trial Assistant (CTA) in a Contract Research Organization (CRO) based in Warsaw. Upon relocating to London in 2016, she seized the opportunity to join TransPerfect Company as a Document Specialist, subsequently transitioning to a role as Quality Specialist. Over the past six years, Sylwia has dedicated her expertise to Japanese pharmaceutical companies, actively participating in the implementation team of an electronic Trial Master File (eTMF) system. She has contributed significantly to enhancing various TMF processes, conducting training sessions for study teams, and fostering a TMF-centric culture within these organizations.

Jen is responsible for building and leading a trial management team for Protas’s trial portfolio and undertaking the role of Product Owner in developing Protas’s unified trial management platform, Cantata. Protas is a not-for-profit organization with a focus on reducing the barriers to the development of better treatments for common diseases so that we can improve patient care and public health outcomes, and more people around the world can live healthier lives. With over 15 years’ experience in the clinical research industry, Jen previously worked in a university setting leading one of the largest academic drug trials in the UK with over 30,000 participants, as well as roles as a CRA and working within a data management group for a global CRO. Areas of specialty include novel trial methodology implementation and all areas of end-to-end trial management across secondary and primary care.

Chris has worked in the Pharma industry for over 30 years. He has been with Novartis since 2021, where as part of the Clinical Document Governance & Management (CDGM) team he is responsible for driving business strategy in relation to clinical document management, as well as being responsible for TMF inspection support, metrics, archiving, change management and engagement activities. In the earlier part of his career, he worked in a variety of roles related to managing proprietary regulated and non-regulated records, eventually leading the R&D Records Management and Archiving team in GlaxoSmithKline. In 2017 moved into the clinical documentation area with a focus on TMF, including governance, process improvement, data migration, inspection support and metrics.

As Director of Client Solutions at TransPerfect Life Sciences, Laurel-Ann Schrader is a resident TMF subject matter expert. Her expertise includes TMF inspection readiness, preparation and support; best practices for clinical document processes, procedures and clinical operations; eTMF implementation and management; and the real-world application of the TMF Reference Model. She previously worked in clinical operations at Ardea Biosciences, BioPharm Systems and Amylin Pharmaceuticals.

Laurel is an active participant and contributor to the TMF Reference Model working groups and is a thought leader in the TMF industry.

With 24 years of industry experience, Carla has worked in both large and small pharma and CROs. Carla started at a Phase I unit in Cambridge and quickly progressed into working in clinical project management. She has been at Orphalan for two years managing their ongoing clinical trial programme in rare and orphan drug diseases.

Orphalan set up an in-house eTMF with the assistance of Veeva in 2023 and are currently working through a programme of TMF migrations to transfer all historical and ongoing studies into the new system.

Kristie manages the TMF team within a healthcare company working with medicinal products, medical devices and general/cosmetics. She is also working on moving from a paper-based TMF to an eTMF, including all the challenges and achievements this brings.

Dave has extensive drug development experience, predominantly in Cardiovascular, Oncology, and CNS, spanning over 17 years. He has led numerous global development projects across the product lifecycle, from first time in humans, registration programmes to post marketing.
His strengths include clinical study design, project and programme management, clinical development planning, strategic vendor/CRO selection, vendor oversight, and inspection readiness.

Dave has particular interest in planning clinical development programmes, possessing advanced knowledge in scenario building, financial budgeting, and forecasting for internal pipeline development. He utilises advanced ‘lean’ methodology and holds certifications as a Prince II practitioner and Black Belt Six Sigma practitioner.
His recent experience involves interactions with the FDA and EMA, as well as leading several MHRA ICH/GCP and CQC inspections.
Prior to joining tranScrip, Dave managed global project operations for a leading POC Device company and served as the Head of Clinical Operations for Evgen Pharma. Previously, he held positions at GSK, IQVIA, ICON, and Illingworth Research, covering therapy areas including Oncology, Cardiovascular, Diabetes, CNS, and Women’s Health.

Sarah Hitching has worked in a GCP environment in the pharmaceutical industry for more than 30 years, initially as a CRA, then progressing to roles as Project Manager/Director, and specializing in TMFs in 2005. As Director of Records Management in a medium-sized CRO, Sarah established an eTMF to handle a large number of TMFs, engaging with all operational functions to ensure a fit-for-purpose final product. Hedian Records Management Ltd. was founded in 2018, providing TMF contract staff, particularly for Inspection Readiness. She is a member of CDISC and the Health Sciences Records and Archives Association (HSRAA). She is currently participating in the CDISC TMF Risk Initiative, leading Section 2 (Defining Risk Criteria) of the White Paper and co-leading the Training.

Henry joined Trial Interactive in 2019 after a decade in the CRO and, before that, pharmacovigilance space. As part of our EU Trial Interactive team, he takes the lead on all UK and Ireland client support and has unique experience in advising academic and government-funded sponsors in TMF best practices.

More recently, he has specialized in guiding “greener” clinical teams in future-proofing clinical document management in team configuration, SOP best practices, eClinical platform selection, and outsourced TMF resource management.

Gordon has nine years of industry experience, working primarily for a clinical study sponsor across several roles, including TMF Lead, Clinical Operations Specialist, and Associate Operations Compliance Lead. Since joining TransPerfect in January 2024 as a TMF Study Owner, Gordon has been applying gained insight and knowledge to develop and implement best practice approaches to support client success across multiple studies.

As Director of Client Solutions at TransPerfect Life Sciences, Laurel-Ann Schrader is a resident TMF subject matter expert. Her expertise includes TMF inspection readiness, preparation and support; best practices for clinical document processes, procedures and clinical operations; eTMF implementation and management; and the real-world application of the TMF Reference Model. She previously worked in clinical operations at Ardea Biosciences, BioPharm Systems and Amylin Pharmaceuticals.

Laurel is an active participant and contributor to the TMF Reference Model working groups and is a thought leader in the TMF industry.

Gill Gittens has 25+ years of TMF-focused experience. Currently, she is the Director of eClinical Strategy and Solutions for TransPerfect Life Sciences. She has a wealth of valuable expertise in strategic account management, operations, eTMF implementation and the ongoing customer success of global eTMF solutions. She is a current member of the CDISC TMF Reference Model Steering Committee and was the co-chair of the Quality Team for the DIA Framework for Paper Destruction Initiative. She is currently working with her industry colleagues to revise the TMF Plan template provided by the Reference Model.

She has a love for writing and has authored several published TMF-related blogs and whitepapers as well as articles in recognised industry journals.

Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. He brings over 25 years of product management, consulting and engineering experience across verticals such as life sciences, enterprise software, healthcare, government, entertainment and manufacturing. Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding and Grants solutions. Jay has also created and managed products for eCTD submission publishing and review, enterprise quality management, document management, computer validation and mobile apps for physicians, sales reps and music and sports fans. Jay holds an MBA from Villanova University and a degree in computer science and physics from Gettysburg College.

Henry joined Trial Interactive in 2019 after a decade in the CRO and, before that, pharmacovigilance space. As part of our EU Trial Interactive team, he takes the lead on all UK and Ireland client support and has unique experience in advising academic and government-funded sponsors in TMF best practices.

More recently, he has specialised in guiding “greener” clinical teams in future-proofing clinical document management in team configuration, SOP best practices, eClinical platform selection and outsourced TMF resource management.