The industry is being impacted by the COVID-19 pandemic at every level. As the industry adapts and reimagines the design and execution of clinical trials, the implementation of decentralized and virtual clinical trials has become a primary focus.

Now, more than ever, we are committed to helping our clients continue the development of their life-saving therapies and navigate this complex research landscape to ensure high-quality clinical trials that prioritize subject safety and support successful marketing applications.

Decentralized & Virtual Clinical Trial Solutions

Patient-centric, flexible strategies and solutions

At Rho, we believe that the best decentralized solutions are patient-centric, customizable, and rooted in a robust Risk-Based Quality Management (RBQM) framework, as specified by the E6R2 guidance.

With patient safety and patient centricity as our primary goal, we use our data-driven RBQM process to evaluate risk and make recommendations for the optimal decentralized solution for your clinical trial or program. This includes providing recommendations for the level of decentralization required (e.g. virtual trials or hybrid approach), as well as strategic plans for remote and central monitoring, technology integration, IP management, and site and patient engagement.

Due to the uncertain and rapidly shifting research site conditions and patient availability, it’s imperative that strategies and approaches to executing virtual research studies are customizable and agile. Therefore, they must be grounded in a robust RBQM framework that can provide data and triggers to determine when a shift in approach is necessary.

Our Approach to Decentralized Solutions

Formal risk analysis 

Our data-driven RBQM process allows us to identify and evaluate risks early, monitor those risks and provide insights to make adjustments throughout your trial. Through this process, we will work with you to determine:

• The type of decentralized solution needed for your clinical trial (e.g. fully virtual or hybrid)
• The most appropriate use of decentralized monitoring strategies, including risk-based monitoring, central monitoring, off-site monitoring and targeted source data verification (TSDV)
• Key Risk Indicators (KRIs), which will provide insights throughout your study to ensure patient safety, trial performance and data integrity

Patient-centric focus

When designing and executing decentralized solutions, our teams focus on ensuring patient safety, increasing patient engagement, and reducing patient burden. When clinical sites are closed and/or patients aren’t able to travel to sites, we have implemented the following solutions:

• Remote consenting
• Remote recruitment and enrollment processes
• Telemedicine visits
• Home health care solutions
• Lab draws at local labs near patient homes
• Direct to patient (DTP) Investigational Product (IP) shipments
• Off-site monitoring
• Centralized monitoring and data visualization

Smart implementation of technology

We understand that technology is a key component of most decentralized solutions, which is why we’ve developed partnerships with technology companies that deliver solutions, including eCOA and ePRO, along with devices and wearables that capture data directly from patients. Smart implementation of technology solutions can help reduce patient burden and increase patient engagement in decentralized clinical trials.

Continuous assessment 

We ensure that any decentralized solutions our teams implement are agile enough to accommodate the shifting conditions at research sites and the ongoing uncertainty related to patient availability. Our flexible solutions can pivot quickly to address insights provided through the monitoring and analytics of our RBQM framework.

Robust documentation of decentralized plans and protocols

Proper documentation is always important, but conducting decentralized trials during this pandemic requires an even greater focus on documentation. We ensure that your study plans, protocol, and reports contain the documentation necessary to effectively execute your trial and properly document your solution for regulatory authorities.

At Rho, decentralized solutions are NOT one-size fits all.

Read our full article on Decentralized & Virtual Clinical Trials here.