4G Clinical Launches Direct-to-Patient Platform


Applied Clinical Trials

4G Clinical has announced the launch of a Direct-to-Patient (DtP) clinical trial platform, offering sponsors the flexibility to ship drug directly from the site, depot, and/or central pharmacy to the patient's home. 

Direct-to-Patient clinical trials are a type of decentralized clinical trial (DCT) where aspects of the trial are conducted at locations outside of the investigator site (e.g. the patient's home). In the midst of the COVID-19 pandemic, clinical trial models are shifting towards DtP to address patient safety & access to trial sites, site capacity challenges, and supply chain disruption.  

Prancer RTSM's DtP Functionality supports all main Direct-to-Patient models including Depot-to-Patient, Central-Pharmacy-to-Patient, Site-to-Patient and Hybrid. This can be set on the patient, study, site and country level, allowing different DtP models within the same study. This becomes especially critical to adhere to different rules and regulations across the globe.

"Given the environment we are in today, sponsors need the flexibility to adapt as this crisis unfolds," says Neta Bendelac, Senior Director of Strategy at 4G Clinical. "Our DtP functionality can be set up for certain periods of time, for all or selected visits, with the ability to turn it off while the study is running. This flexibility can help sponsors continue research through the COVID-19 pandemic, returning to normal settings after it has passed." 

The ultimate goals of Direct-to-Patient clinical trials are to improve enrollment and ease the burden of patients to access trial sites. While COVID-19 may be the catalyst for moving the industry towards a DtP approach, the benefits remain clear. 

"Our reason for the launch of our DtP Functionality is two-fold," says David Kelleher, CEO of 4G Clinical. "First, it enables clinical research to continue and for patients to safely receive their medications. Second, it is our belief that DtP models will be necessary long after the COVID-19 pandemic has ended. DtP puts patients first, and once the infrastructure is there to support it, we hope to see it continue."

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