The Transparency Virtual Trials hub integrates all the digital applications necessary to execute clinical trials using digital, virtual and other remote methods, including recruiting patients and obtaining consent remotely, conducting clinical trial patient visits in the home or workplace using telemedicine and mobile health, and managing data originating from diverse sources securely, confidentially and in a form that facilitates its use in electronic regulatory submissions.
Transparency Virtual Trials provides the flexibility to configure and implement 100% virtually conducted protocols, as well as “hybrid” studies that use a mixture of virtual and in-person data collection visits. Our approach is very adaptable: TLS can take on all of the service functions to implement and complete a virtual study, or share responsibility with a sponsor’s clinical development team and/or their existing CRO partner.
The Transparency Virtual Trials hub is used by members of the research team – study coordinators and investigators – to enroll patients and collect data during study visits. It is also used by patients to schedule visits, communicate with study coordinators using telemedicine and other communication technologies, and transmit data to a secure data repository. Patients can also track their progress and remain compliant with study requirements on their own and via receipt of automated reminders.
TLS can tailor study recruitment campaigns using both social media and conventional approaches through relationships with online patient communities, disease foundations, and third-party trial recruitment companies.
Virtual Scheduling and Visit Management
The virtual trials hub scheduling function aims to remove the inconvenience of scheduling study visits with patients over the phone. A standard module on the study hub includes the ability for study staff to block off availability for clinical trials visits, and for patients to schedule and reschedule appointments. This saves time at the site and allows patients to reschedule visits easily.
Telemedicine-enabled Video Visits
Video visits are at the heart of conducting a virtual clinical trial, and ensures data is collected appropriately. The virtual study hub also incorporates the ability to connect with a variety of mHealth and other digital devices, and to integrate those data collection streams into the study database
ePRO: Electronic patient-reported outcomes
The virtual trials hub acts as a conduit to solicit and receive ePRO — electronic patient-reported outcome — data from patients. It can be configured to collect data from a sponsor’s preferred ePRO methods, or a module can be enabled that sends ePRO’s to patients via their smartphones to be completed during the study. The patient version of the hub also contains email and text message reminders to ensure the completion of ePRO’s.
The virtual trials hub can connect to all major electronic data collection (EDC) systems and launches the forms necessary to complete each study visit. The software is configured for study coordinators to view the applicable electronic case report forms (eCRF’s) at the same time they are communicating with patients via telemedicine.
Between study visits, patients can continue to collect valuable data in real-time utilizing mHealth monitoring applications. The types of data that can be collected are rapidly increasing and already include step counts, general activity, motor skills, vital signs, and cardiovascular parameters.
Data Management and Visualization
Electronic Trial Master File
An e-Trial Master File can be kept on the virtual trials hub through an online, cloud-based service interface. This eTMF module offers the flexibility to be configured and integrated with third-party software or an existing software provider. TLS can consult with sponsors to determine the best choice, based on the protocol design and other factors.
Investigators, coordinators, and data monitors can securely upload documents to the cloud eTMF from any location. This saves administrative time and prevents confusion throughout the life of the clinical trial.
TLS provides real-time data visualization and analysis capabilities. As clinical trials become more complex and the use of adaptive designs become more common, the ability to view data as it is collected is essential. Data monitors and investigators can ensure proper data collection and run preliminary analyses at any time and without advanced programming needs.
This aspect is of paramount importance for TLS. As such, the Transparency Virtual Trials hub is fully compliant with HIPAA and other related regulations. All data and the application itself are stored on a secure cloud database, and the application itself is hosted on AWS.
Contact us to learn more about Transparency Virtual Trials.
|What It Is||What It Does|
|Transparency Protocol Crowdsourcing||Web-based surveys, incentive system that recognizes outstanding participation, and data analysis methods||Turns input from patients and professionals into optimized protocols|
|Software platform, mHealth devices, and related methodology||Integrates the software systems that collect patient data outside of the clinic|
|Transparency Personalized Digityping||Software platform, mHealth devices, and data aggregation services||Aggregates mHealth data for patients’ self-monitoring and industry analysis|
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