Project Covalence: Streamlining COVID-19 Clinical Trials

Project Covalence, a collaboration between TrialSpark and Dr. Mark Fishman, aims to revolutionize the way we conduct COVID-19 clinical trials. The project recognizes the critical need for faster and more efficient trials to combat the ongoing pandemic.

• Traditional clinical trials are often time-consuming and costly, hindering rapid development of treatments and vaccines.
• Project Covalence addresses these challenges by providing comprehensive support to accelerate COVID-19 clinical trials.

Optimizing for Community and Home Settings

Project Covalence's platform is uniquely optimized to support clinical trials in community settings or at patients' homes. This approach minimizes the burden on hospitals and health systems, ensuring greater accessibility and efficiency.

• The project leverages telemedicine and remote data collection technologies to facilitate patient engagement and trial participation.
• This innovative approach allows for a more decentralized and flexible trial design, leading to faster recruitment and data collection.

Comprehensive Support for Clinical Trials

Project Covalence provides a wide range of services to support all aspects of clinical trials, including:

• Trial execution
• 21 CFR Part 11 compliant remote data collection
• Telemedicine
• Biostatistics
• Sample kits for at-home specimen collection
• Protocol writing

Collaboration and Shared Infrastructure

Project Covalence encourages collaboration among researchers across academia and industry. To facilitate coordination, the project is developing master protocols for platform studies, enabling:

• Shared control arms for increased efficiency and data comparability.
• Adaptive trial designs that allow for flexible adjustments based on emerging data.

Accelerating COVID-19 Research with Innovative Approaches

Project Covalence's focus on community and home-based settings, combined with its comprehensive support services, offers a powerful solution to accelerate COVID-19 research. By leveraging telemedicine, remote data collection, and innovative trial designs, the project is helping researchers overcome the traditional barriers to rapid development of life-saving treatments and vaccines.

• This initiative exemplifies the power of collaboration and innovation in tackling complex global health challenges.
• By streamlining clinical trials, Project Covalence is playing a vital role in bringing effective solutions to the COVID-19 pandemic.

Get Involved

If you are interested in contributing to Project Covalence or require support for your COVID-19 clinical trial, please contact the team at ProjectCovalence@trialspark.com or visit www.projectcovalence.com.