E-Technologies add potential opportunities and risks to clinical research, but a lack of familiarity can be a barrier to their use in decentralized trials. Sponsors need to know “What good looks like” for each technology or service provider and need reassurance that newer technologies, or their providers, will not invalidate trial results оr fail to deliver operational value. But most trial Sponsors lack suitable RFI questionnaires to evaluate providers, or even clarity about what questions to include.
This webinar will cover the perceived and actual risks that concern trial sponsors when considering using eClinical services, especially in support of decentralized trials. Expert speakers with significant experience within sponsors and quality auditing will share their experiences and answer questions on problems arising – and innovative solutions – for the effective selection and qualification of eClinical service providers.
The webinar will also introduce an innovative solution using latest industry standards to evaluate vendors objectively for:
- eHealth Records
- Electronic Clinical Outcomes Assessment (eCOA)
- Electronic Informed Consent (eIC)
- Electronic Regulatory Binders/Electronic Investigator Site Files (eISF)
- Electronic Trial Master Files (eTMFs)
- Interactive Response Technologies/Interactive x{Telephone/Voice/Web} Response System (IRT/IxRS)
- Mobile cardiac monitoring
- Mobile HCP visits
- Telemedicine
- Wearable Devices/sensors
- Digital design
Key Learning Objectives:
- The perceived and actual risks that concern trial sponsors when considering eClinical services, especially in support of decentralized trials
- How to focus on the big picture as a sponsor and reach more patients
- Challenges and solutions when assessing the quality of eClinical service providers
- The latest, industry-leading standards for eClinical service providers
- How to identify all potential risks of new technology providers with a standardized approach
