Donna is a business consultant who has more than 25 years of experience in study operations, including clinical operations, safety, data management, biostatistics, clinical supply management and TMF management. Her vast experiences dealing with small to large pharma companies, academic centers, regulatory agencies, CROs and investigator sites provide her with the knowledge needed to assist research organizations in all areas of clinical compliance. She began her career in clinical research at GlaxoSmithKline where she spent 15 years in Phase I Clinical Research Operations. In 2005 Donna founded DWD & Associates. In her capacity as President, she has led several large projects performing operational gap analysis and implementing process improvement initiatives for sponsors, CROs and clinical sites. She is an experienced auditor and has expertise in SOP development for both investigator and sponsor organizations. She has led the implementation of eSource and electronic Trial Master File solutions, and has expertise in clinical validation of these systems. In June 2015, DWD & Assoc became Just in Time GCP to better describe the services and capabilities of the organization. Donna remains as President.
Renee Fate – Director, Clinical Records Management
Renee Fate has more than 13 years of clinical record management experience. At Allergan, she leads the TMF Compliance Specialists team responsible for providing program-level support to ensure compliance with global TMF standards and internal processes. She collaborates with TMF stakeholders to integrate inspection readiness activities into daily processes. Prior to Allergan, Renee worked at Kythera Biopharmaceuticals and Amgen specializing in TMF compliance, inspection readiness, and transitioning paper-based TMFs to be eTMFs.
Laura Forcade – Clinical Trial Master File Specialist
Laura has a broad background and expertise with GxPs from her 20 years’ experience in the pharma/biotech industry, including regulatory Inspection experience for GMP and GCP. In her current role as Clinical Trial Master File Specialist, Laura is responsible for maintaining eTMFs for multiple global clinical trials. She also led the study team’s implementation of the Electronic Document Management system. She continues to provide systems support for cross-functional teams. Prior to working at Alexion Pharmaceutical, Laura held Scientist/QA and Medical/Regulatory Affairs SOP Manager at Boehringer Ingleheim.
Jennifer Maier – Associate Director, R&D Quality Compliance
Jen has worked in the pharmaceutical industry since 2006 and is an Associate Director in the Research & Development Quality Compliance division of Alexion. Jen provides quality oversight for activities relating to pharmacovigilance, regulatory, and medical. Jen has led teams responsible for creating and implementing processes for TMF Safety Documentation, process improvement initiatives and training compliance. Jen’s experience within industry includes pharmacovigilance compliance, auditing, case processing, and patient support program delivery, design and compliance oversight. Jen’s 13 years of medical experience includes orthopaedics, pediatric – outpatient, urgent care, intensive care, transport and emergency care, and pediatric endrocrinology clinical trials.
Jen has a BS and AS in Nursing from Indiana University Purdue University of Indianapolis. She is a Multiple Sclerosis Certified Nurse. Jen is Green Belt certified and holds a DIA Certification in Clinical Safety & Pharmacovigilance.
Lisa Mulcahy has 25+ year career in the pharmaceutical industry, in the areas of Clinical Operations and Quality Management with specialty in process for the management of records created and maintained in support of the clinical trial process. More than 10 years ago, she became an independent consultant, focusing solely on the Trial Master File management. She has very deep experience assisting clients with assessment and improvement of their current state and associated processes, development of future design, writing of process-related documentation, and implementation of systems for the management of electronic records of the TMF. She is experienced in the quality assessment of study-specific TMFs.
Lisa is co-founder of the team of industry representatives that created, maintains, and expands the TMF Reference Model and remained its co-leader through 2015. She continues to contribute to the team’s leadership and initiatives as a TMF RM Steering Committee member. Lisa recently lead a team of industry representatives to review and revise the Framework for the Destruction of Paper, v2.0.
Mark Romano is an R&D Customer Success Manager for Veeva with a focus on Vault Clinical applications, namely eTMF, CTMS, and Study Startup. Mark is responsible for aligning with customers to promote strategic focus and strong program management, supporting customers through education on new and enhanced Vault functionality, evaluating how customers manage their Vault applications to identify efficiency and effectiveness gains, and guiding customers on industry trends and best practices.
Prior to joining Veeva, Mark worked in the pharmaceutical industry for over 18 years at multiple pharmaceutical companies and contract research organizations. In that time, he held a variety of positions in Clinical Operations – including Clinical Research Associate and Quality Assurance Auditor – and spent more than a decade working in a variety of clinical trial/project management positions, including director-level roles.
Kate has worked in the biopharmaceutical industry for 20+ years. In her role as Senior CTA – Clinical Systems, Kate manages the TMF process as well as clinical trial disclosure. Kate recently managed a full-scale project to revamp Alkermes’ TMF processes, including adopting the DIA Reference Model and moving into an electronic TMF. This is Kate’s third TMF Summit.
Supriya Shoroff is a subject matter expert and Clinical Documents Manager at MediVector Inc. based in Boston.
Supriya oversees the TMF operations in-house and the CRO’s management of eTMFs. Supriya has successfully implemented the electronic Trial Master File solution at MediVector and is the TMF process owner.
Currently, Supriya is working on data migration projects and leading the migrating effort of about 200,000 + documents into the new eTMF solution.
Bryan Souder is Director, TMF Head at Merck & Co., INC., USA. He has a BS from Radford University, a Six Sigma Greenbelt, and 22 years of clinical trial research experience. His current focus is being TMF Head. Prior to leading the department Bryan was the eTMF “Global Implementation Lead” Merck & Co., Inc. He has conducted eTMF application & process training in 18 countries and has hosted multiple sponsor inspections.
Stephanie Viscomi is Head of TMF at ImmunoGen in Boston. She has more than a decade of experience that predominately pertains to TMF. In that time, Stephanie has gained a unique understanding of the TMF from both views from CRO to sponsor. In her role at ImmunoGen, she is working to enhance the TMF platform while building an operational infrastructure to improve study conduct and resource allocation. Prior to her current role, Stephanie worked with and managed multiple global TMF teams providing support to large volume TMF’s all while meeting global standards and internal processes. Also during Stephanie’s tenure, her experience includes the development of effective metrics and cross-departmental training programs, extensive enhancements to TMF oversight processes, inspection readiness compliance, and creation of a cross-functional project coordination department.