There is tremendous regulatory support for utilizing risk in managing clinical trials. Risk-based monitoring has been growing in popularity over the past 15 years and this year's Covid-19 pandemic on clinical trials has only driven this growth further.

 

With the increasing power of artificial intelligence and machine learning in TMF management, applying risk strategies in TMF oversight is becoming a means of gaining efficiencies without impacting quality. This session examines the applications of AI and machine learning in planning and conducting TMF oversight activities. We also discuss how these technologies will empower remote site access and clinical trial collaboration.

Who is this webinar for?

• Trial Document and Records Management 
• Clinical Operations 
• Quality Assurance/Clinical Compliance 
• Regulatory Affairs/Operations 
• Study/Project Management Personnel
• Sponsors, CROs, Vendors, and Consultants 

Speakers

Paul Fenton- CEO, Montrium

Paul has significant industry experience at a senior management level in the development, deployment, and management of computerized systems for use in regulated clinical trials. He co-founded Montrium in 2005 and has a strong background in CDISC and ICH standards, as well as in the integration of systems and processes for clinical trials. Paul is the co-chair of the eTMF-EMS standard initiative and TMF reference model steering committee model.

      
Donna Dorozinsky - CEO, Just in Time GCP

Donna is a business consultant with over 30 years of experience in study operations, including clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. Her vast experience dealing with small to large Pharma companies, academic centers, regulatory agencies, CROs, and investigator sites provides her with the knowledge to assist research organizations in all areas of clinical compliance. She is a member of the TMF Reference Model Steering Committee, a member of the Association of Women Entrepreneurs. Donna is a founding member of the Society of Nurse Scientists, Innovators Entrepreneurs, & Leaders.