Decentralized study solutions to reach participants where they are and keep your study on track
Digital technologies have seen increasing acceptance among global stakeholders and the COVID-19 pandemic has only increased this trend and placed a spotlight on the necessity of these tools. Thankfully, there is also an increasing spectrum of validated systems and devices to gather endpoints for clinical trials across all therapeutic areas.
Global Virtual Study Consulting
- Advise clients on the feasibility of virtual assessments: endpoints, devices, visits, monitoring
- Provide regulatory support at a global and local level, including the latest COVID-19 updates
- Provide specialized team members with new roles: virtual PI and nurse (site-less approach); central and remote monitors; data monitoring committee
- Design virtual studies using the most appropriate systems and tools given the study type, indication, and population
and EDC Solutions
- ePRO / eDiary
- Remote training of patients, site staff, and study team
- Remote / Virtual visits
- Remote source document verification
- Wearables / biosensors
- Passive smartphone data
- Digital interventions / therapeutics (e.g., ad-hoc apps)
Central Platform for Decentralized Trials
- Central repository integrating data from all sources including e-tools, virtual, and hybrid studies
- Flexible, fully scalable and customizable to each study with role-based security
- Agnostic API integration from multiple devices / wearables
- Reliable measurement of multiple endpoints in most therapeutic areas
- GDPR and 21 CFR Part 11 compliant
- Customer Portal and Dashboards with real-time information on key metrics
TFS selects the best digital technology based on your study’s requirements. Our preferred digital systems and tools for virtual studies, chosen for their flexibility and capacity to adapt to almost any kind of project include Medidata Rave, TrialMaster, Trial Online, and HumanITcare. It’s about agility and accuracy.
For 25 years our clients have trusted us with their clinical development programs, and now more than ever we are prepared to offer the precise solutions you need to keep your project on track.