Bridging Regulatory Quality and Operational Efficiency with Open Standards
Sponsored by: GoBalto
- Regulatory Quality
Date: 28 August
Time: 3PM London/10AM ET/7AM PT
Central to the elimination of bottlenecks and unnecessary rework in the clinical trial continuum is automation and integration between eClinical applications based on open standards.
Existing systems (CTMS, eTMF, etc.) only support clinical trial functions in silos. Eliminating inefficiencies and bottlenecks associated with disparate data silos is critical to the goal of reducing cycle times in clinical trials. The challenges in integration of eClinical systems stems from the lack of standards, it’s simply not enough to have APIs available.
Standards provide stakeholders with a basis for mutual understanding and are critical tools to facilitate communications. Open standards help fuel compatibility, interoperability, simplify trial executions and speed time-to-market.
The new TMF Exchange Mechanism provides the cornerstone in collaboration between all study startup and executive stakeholders, including sponsors, CROs, investigative sites and regulatory and ethical committees.
Why is this model so critical to all organizations engaged in clinical trials?
Associate Director, TMF Operations Sarepta Therapeutics
Kristen has worked in the pharmaceutical industry for over 10 years and specializes in ICH GCP E6(R2) requirements in Rare Diseases. In addition to experience with Wyeth, Pfizer, Bioverativ, and Sanofi, she currently Heads the TMF Operations function at Sarepta Therapeutics. Kristen has served as a Research Compliance Officer and consultant advising IRB Board Members, Investigators and study teams on regulatory requirements and best practices. In addition to her service on the DIA TMF Reference Model eTMF Exchange Mechanism Standard Sub-Committee and the DIA TMF Reference Model Framework for the Destruction of Paper Sub-Committee, Kristen has lead numerous study eTMF configurations, migrations, validations and implementations. Kristen holds a Master of Science degree in Regulatory Affairs for Drugs, Biologics and Medical Devices from Northeastern University in Boston, MA.
President & CEO Montrium
Paul co-founded Montrium in 2005 and has significant industry experience at a senior management level in the development, deployment and management of computerized systems for use in clinical trials. Paul has worked on major clinical technology projects both in Europe and North America and has a strong background in CDISC and ICH standards, and in the integration of systems and processes for clinical trials. He speaks regularly at industry events and is actively involved in several projects for the development of clinical research standards and platforms. Paul holds a degree in management from London Metropolitan University and an MBA in Technology Management from the Université du Québec à Montréal.
Senior Director, Industry Strategy goBalto
Elvin is a recognized industry expert in clinical trials, having over twenty years of experience working as a Clinical Business Analyst Consultant at major pharmaceutical companies including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in goBalto's effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a Master of Science in Industrial Engineering from Aalborg University.
Key Learning Objectives
- The importance of open standards in the eClinical space
- The business problems faced by different stakeholders in the integration of eClinical systems
- Provide an overview of the new TMF Reference Model Exchange Mechanism
- Discuss a specific use case on how this model could be implemented for an IRB/EC integration
- Technology vendor roles responsible for the exchange of trial documentation
- Internal Review Boards (IRB) and Ethical Committees (EC) roles engaged in trial documentation review/exchange
- Sponsor and CRO roles responsible for site identification
- Sponsor and CRO roles responsible for feasibility assessment
- Sponsor and CRO roles responsible for selection and activation
- Sponsor and CRO roles responsible for collecting trial documentation
- Sponsor and CRO roles responsible for regulatory and ethical study approvals