What are Decentralized Clinical Trials?
The FDA defines decentralized clinical trials as those executed through telemedicine and mobile/local healthcare providers, using processes and technologies that differ from the traditional clinical trial model.
Decentralized clinical trials are conducted remotely, with patient subjects remaining at home during a significant portion, or all, of the study. However, the decentralized clinical trial model is designed for more just patient participants.
- By using these same technologies and processes, plus new innovations, trial tasks that were originally only possible through traditional, face-to-face methods can now be remotely executed – efficiently and effectively.
- Moving to this decentralized model promises to mitigate some of the burden and cost of traditional methods while aiming to preserve the quality of oversight.
Biorasi offers two types of solutions to facilitate decentralized clinical trials – for patients, sites, CROs and Sponsors.
Remote Patient Solutions
Decentralized trials offer many advantages for patients wanting to participate in clinical research:
- They can drastically reduce the scheduling and travel burden on patients – providing care from the comfort of the patient’s home.
- They can, likewise, expand the access of the study to subjects that would have been unavailable under more traditional trial protocols – connecting patients to trials on a global scale.
These benefits come with their own set of challenges, however, including investigational product distribution to more remote locations, as well as oversight of compliance and study procedures in the patient’s home.
Biorasi has the tools and experience to foresee and overcome these challenges. Our Remote Patient Solutions offer a complete decentralized trial strategy to support the remote patient experience.
Telemedicine
Home Health Coordination and Management
Mobile Devices (eCOA, ePRO, etc.)
Patient Interactive Portals
IP and Study Supply Logistics
Sample Logistics
Remote Monitoring for SSV, SIV, and SOV
Remote Source Data Verification (Remote SDV) Solutions
TALOS™ Technology Solutions
Mobile Device Data Capture Solutions
24/7 Real-Time Data Transparency
Remote Monitoring Solutions
Once patients have been recruited for a decentralized clinical trial, Biorasi’s Remote Monitoring Solutions are ready to be incorporated, offering Sponsors, CROs, and clinical staff the advantages of remote site visits:
- Scheduled visits for site selection, initial visits, and site close out can be addressed remotely, leveraging digital technology and online workstations to reduce costs, expand global scope, and keep milestones on track.
- With Biorasi’s TALOS™ system, trial data can be collected through multiple remote mediums, viewed in real time throughout the study, and standardized to validate results.
Decentralized clinical trials can present obstacles to Sponsors and CROs, inclusive of patient adherence to treatment, coordination of technology solutions, and stakeholder communication.
Biorasi has the tools and experience to prevent and overcome these obstacles. Our Remote Monitoring Solutions offer a complete decentralized trial strategy to support the remote site experience.
Solutions for the COVID-19 Crisis and Beyond
Biorasi’s expertise in Decentralized Clinical Trials offers a comprehensive strategy for the challenges associated with COVID-19 and other healthcare crises. Critical elements – such as patient interaction and stakeholder communication – are facilitated effectively and efficiently through our remote solutions:
Remote Patient Solutions
- Improve recruitment speed and efficiency while reducing the scheduling and travel burden on patients
- Access patient subjects on a global scale to expand recruitment parameters
Remote Monitoring Solutions
- Seamlessly integrate existing clinical trials into virtual programs
- Reduce health risk to patients and clinical staff with remote strategies for site activation, monitoring, and closeout
- Take control over data capture with 24/7 real-time access to data and standardization and analysis of all data collected to validate the trial
A Spectrum of Decentralized Solutions
Biorasi knows that each clinical trial is unique. Completely site-less trials may not always be the best option. That’s why we offer a wide spectrum of decentralized solutions with remote components that can be customized to fit all trial parameters.
Biorasi recently conducted a webinar that focused on how a decentralization strategy can keep clinical trials on track during COVID-19 and beyond.
Looking for Advice?
We have experts on staff that would love the opportunity to speak to you about your trial.
Complete the form on the right and one of our experts will contact you.
18851 NW 29th Ave. Suite #800
Aventura, Florida 33180
Phone +1 786-388-0700
Fax +1 786-388-6044
