Gillian Gittens, Director of eClinical Strategy and Solutions, is a TMF industry veteran with over 25 years’ experience. Gill has a wealth of insight and expertise in managing TMF services and delivering ongoing customer success across all aspects of TMF operations. A member of the CDISC TMF Reference Model Steering Committee and Project Management Team leading the V4 initiative, Gill has key expertise and insight in industry best practice, regulatory guidance and the future of TMF management.

On the journey from paper TMF to eTMF, supporting clinical studies across IMPs, medical devices, cosmetics, and general products.

Karla Navera-Andersen is a Senior eTMF Manager at Zealand Pharma with nearly 17 years of experience in TMFs. She holds a Master of Arts in English and a Pharma Consultant Diploma. Karla began her career in a paper TMF archive and has since worked on both the CRO and sponsor sides, across Clinical Operations and Regulatory Affairs. She leverages her broad industry experience to drive stakeholder engagement, foster cross-functional alignment, and simplify the complexities of eTMF.

Michael Smyth has 30+ years of experience working in the pharmaceutical clinical development industry across sponsors and CROs. Michael, fueled by, his passion consults with our pharmaceutical, biotechnology, medical device, and CRO clients to determine how to most efficiently use our Trial Interactive platform to streamline clinical development processes for all stakeholders. Smyth is an active member of the Drug Information Association and frequent blogger on all things focused on improving the entire clinical trial landscape to bring products to market faster.

Kelsey Brown spearheads TransPerfect’s Medical Writing division, bringing together strategic content creation and technology to develop high‑impact materials across preclinical, clinical, and commercial. Kelsey’s 10+ years of expertise includes clinical research and development, medical affairs, data transparency, and health literacy. Previous to joining TransPerfect in 2018, Kelsey worked in medical writing both in the sponsor and CRO worlds. With deep expertise in scientific communication and a passion for empowering patients, Kelsey combines analytical insight with empathetic leadership. 

Henry has been supporting clinical activity across the pharmacovigilance, CRO, and now TMF FSP space for 12 years; and has supported 50+ eTMF implementations and 30 FSP model activations in the last 18 months. Working across multiple support models, he remains a market leading expert in adaptable compliant workflows for full TMF compliance. He works directly with sponsors, providing full TMF management, alongside CROs as a collaborative partner, and advises on appropriate technology platforms and configurations based on client need. He also sits at the forefront of the TransPerfect AI rollout, helping with AI for TMF Management, eCTD Submissions, and Medical Writing.

Katherine Cianciarelli is a senior product manager with almost a decade of experience in eClinical technology. An engineer by trade, she focuses on building practical AI tools that improve clinical research workflows. Her work centers on finding smart ways to optimize processes while ensuring responsible and compliant technology use, always seeking to bridge the gap between technical innovation and real-world research needs.

Lisa entered the pharmaceutical industry in 2001 and moved into clinical research in 2006, supporting trials across various therapeutic areas at CROs. In 2009, she transitioned to the vendor side, helping global pharmaceutical clients implement eTMF and providing ongoing services. She now leads the professional services team, focusing on document services and leveraging her expertise in inspection readiness, TMF QC, document destruction, and archiving. Lisa is based in our London office.

Ameena holds a master’s degree in biomedical Methods and Technology from Malmö University and brings over 15 years of pharmaceutical industry experience. Her expertise spans system implementation, validation, audits, compliance, and TMF oversight. Ameena began her TMF career at Data Reduction Systems in New Jersey and has continued to grow her leadership in the field. For the past six years at Zealand Pharma A/S, she has worked alongside cross-functional teams to advance system capabilities and support the evolving needs of clinical operations.

Since November 2021, Anita Thomas has been serving as a Documentation Specialist at Priothera SAS in Saint-Louis, France. Her previous roles include TMF Manager for Outsourced Studies at Novartis (2020–2021) and Clinical Trial Documentation Manager at Santhera (2017–2021), both based in Switzerland. Anita also held positions such as Trial Documentation Specialist at Actelion, ESOPs Reviewer at Novartis, and Technical Writer at Roche. Earlier in her career, she worked as a Business Process Coordinator at Roche, SUSAR Submissions Coordinator and Clinical Trial Administrator at Actelion, and Clinical Trial Associate at Hesperion Ltd, building deep expertise in clinical documentation and operations.

Jay leads the design and development of product features and capabilities for Trial Interactive. With over 25 years of experience in product management, consulting, and engineering, he has worked across life sciences, enterprise software, healthcare, government, entertainment, and manufacturing. Before TransPerfect, Jay led cloud migration initiatives at Medidata and Sparta Systems and managed solutions including clinical portals, eTMF, CTMS, RTSM, EDC, and grants. He has also built products for eCTD submissions, quality and document management, computer validation, and mobile apps for physicians, sales teams, and consumers.

Katrin Simioni is the Deputy Head of Clinical Operations at the AO Foundation, a global leader in education, research, and innovation in musculoskeletal trauma care. She holds a PhD from ETH Zurich and the University of Zurich and has over 10 years of experience managing international clinical studies and leading AO’s multidisciplinary operations team. Katrin is committed to advancing technological innovation in clinical research, ensuring AO remains at the forefront and continues to attract world-class surgeons in support of its mission.

An experienced Senior CRA, the founder of Monocytes launched the company with a mission to enhance site performance and data quality in clinical trials by preventing common errors—much like monocyte cells protect and improve health in the body.

Michael Smyth has 30+ years of experience working in the pharmaceutical clinical development industry across sponsors and CROs. Michael, fueled by, his passion consults with our pharmaceutical, biotechnology, medical device, and CRO clients to determine how to most efficiently use our Trial Interactive platform to streamline clinical development processes for all stakeholders. Smyth is an active member of the Drug Information Association and frequent blogger on all things focused on improving the entire clinical trial landscape to bring products to market faster.

Graham brings extensive experience across pharmaceutical, biotech, and CRO organizations. With a career that began as a statistician in the UK, he has held leadership roles in the US, Germany, and the UK, overseeing global teams across statistics, data management, programming, EDC, medical writing, and more. Graham is passionate about driving operational excellence, digital transformation, and cross-functional growth within clinical development. He joined MAC in mid-2024, where he continues to lead innovation in biometrics and beyond.