VISITOR Clinical Study Demonstrates Feasibility and Utility of Transparency Life Sciences’ New Virtual Trials Platform

Transparency
Virtual Trials
Brings Clinical Trials Direct-to-Patients

 

 

Virtual Trials Are Here. We Have the Tools and Experience to Make Them Work.

Transparency Virtual Trials aims to reduce or eliminate site visits, improving patient recruitment and retention and providing more informative and relevant patient data.

Direct-to-patient Transparency Virtual Trials services are delivered in the patient’s home through a proprietary platform that integrates clinical researcher-supervised video visits and regulatory-compliant tests and evaluations conducted using “Trial-in-a-Box” digital technologies.

 

  • Investigators conduct remote visits with patients in their homes
  • Our virtual visits hub efficiently collects and uploads complex streams of data directly from patients via mobile and wearable devices to the study team
  • Allows sponsors to centrally manage studies while maintaining the highest levels of patient safety, GCP and regulatory compliance
  • Works with virtual or hybrid clinical trials

Virtual Trials Are Here. We Have the Tools and Experience to Make Them Work.

Transparency Virtual Trials aims to reduce or eliminate site visits, improving patient recruitment and retention and providing more informative and relevant patient data.

Direct-to-patient Transparency Virtual Trials services are delivered in the patient’s home through a proprietary platform that integrates clinical researcher-supervised video visits and regulatory-compliant tests and evaluations conducted using “Trial-in-a-Box” digital technologies.

 

  • Investigators conduct remote visits with patients in their homes
  • Our virtual visits hub efficiently collects and uploads complex streams of data directly from patients via mobile and wearable devices to the study team
  • Allows sponsors to centrally manage studies while maintaining the highest levels of patient safety, GCP and regulatory compliance
  • Works with virtual or hybrid clinical trials

TVT Digital Platform: Purpose-Built for Virtual Trials

Transparency Life Sciences has created a nimble and efficient clinical trials services platform that replaces many aspects of a clinical trial with automation and virtualization by reducing or eliminating patient site visits. These efficiencies benefit recruitment and retention, while providing more informative and relevant data.

TLS’s clinical research staff deliver direct-to-patient TVT services through a proprietary platform that integrates video visits and a wide variety of regulatory-compliant telemedicine technologies delivered via “Trial-in-a-Box” logistics capabilities. We also seamlessly incorporate visiting health care providers and other “high-touch” services as needed.

TLS is a pioneer in advancing the wave of innovation that is reinvigorating drug development. We have worked with sponsors, partners, and regulators to develop our distinctive, integrated approach to virtual clinical trials.

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Transparency Virtual Trials integrates the following core functionality areas:

 

Virtual Scheduling and Visit Management

Visit Scheduling

TVT scheduling functionality 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 ensure 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
 

Patient Monitoring

ePRO: Electronic Patient-Reported Outcomes

The virtual trials hub acts as a conduit to solicit and receive ePRO 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.

EDC Integration

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.

Continuous Monitoring

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.

Data Visualization

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.
 

Security

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.

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