Managing DeCentralized Virtual Trials
KNOWLEDGE CENTER

De-Centralized / Virtual Trials

Clinical trial process plays an essential – but expensive – role in demonstrating the efficacy and safety of a novel pharmaceutical compound. Unfortunately for pharmaceutical developers, analysts estimate that only 1 out of every 10 drugs that start the clinical trials process are granted FDA approval.

Virtual clinical trials are a relatively new method of collecting safety and efficacy data from human trial participants. These trials take full advantage of the omnipresent technology and online engagement that are a part of its subjects’ lives, by using electronic versions of all trial processes including recruitment, informed consent, patient counseling, and data collection.

MakroCare Virtual Trials platform 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.

We provide 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: MakroCare 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.

Virtual Trials integrates the following core functionality areas:

Virtual Scheduling and Visit Management

The virtual trials platform 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 platform 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 platform 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 (eCRFs) 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. MakroCare can consult with sponsors to determine the best choice, based on the protocol design and other factors.

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. MakroCare can consult with sponsors to determine the best choice, based on the protocol design and other factors.

Data Visualization

Platform has 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 MakroCare. As such, the Virtual Trials platform is fully compliant with HIPAA and other related regulations.

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