At Your Research, we understand the evolving landscape of clinical trials and the need to adapt to changing circumstances. The COVID-19 pandemic has prompted a shift towards alternative approaches, such as fully remote trials, to ensure the continuity of critical research. In this case study, we will explore the immense benefits of utilizing Your Research software in a fully remote clinical trial.
Background: A Phase III Clinical Trial for Depression Treatment
A leading pharmaceutical company aimed to develop a groundbreaking medication for depression treatment. Their plan was to conduct a phase III clinical trial with a substantial sample size of 1,000 participants. However, the challenges posed by the pandemic necessitated a fully remote approach to ensure the safety and well-being of participants.
Challenge: Ensuring Data Accuracy and Reliability in a Remote Setting
The primary challenge faced was how to maintain the accuracy and reliability of data collected remotely, considering the absence of in-person visits. To overcome this hurdle, they sought a software solution that could facilitate participant recruitment, informed consent, data collection, and monitoring seamlessly.
Solution: Your Research's Modular Clinical Trial Management Software (mCTMS)
Recognising the need for a comprehensive solution, the pharmaceutical company chose Your Research’s mCTMS for their fully remote trial. Our software offers a user-friendly Electronic Data Capture (EDC) system that empowers remote data collection, monitoring, and management. It provides a secure platform for creating electronic case report forms (eCRFs) and ensures reliable data transmission and storage.
Trial Recruitment and Informed Consent in the Digital Realm
The trial recruitment process was conducted entirely online, leveraging the power of social media, email, and other digital channels. Potential participants underwent remote screening using an online questionnaire to assess eligibility. Once determined eligible, participants received detailed trial information and were able to provide informed consent conveniently through the online platform.
Efficient Remote Data Collection with eCRFs
The eCRFs, customized to capture primary and secondary endpoints, played a pivotal role in remote data collection. Participants were required to complete the eCRFs at regular intervals and submit them online. The system was designed to identify any missing or incomplete data, enabling the study team to proactively follow up with participants remotely and ensure data integrity.
Real-time Monitoring for Timely Action
Your Research’s software facilitated real-time monitoring of trial data, empowering the study team to promptly address any potential issues. For instance, the system would automatically notify the team in the event of a participant reporting a serious adverse event, ensuring immediate action could be taken.
Conclusion: Advancing Clinical Trials through Fully Remote Approaches
In conclusion, the adoption of Your Research’s software in fully remote clinical trials brings forth numerous benefits. Our software enables seamless participant recruitment, convenient informed consent processes, reliable remote data collection, and efficient real-time monitoring. By embracing fully remote approaches, researchers can navigate the challenges of the pandemic while ensuring the progress of vital medical research.
Partner with Your Research to revolutionise your clinical trials through fully remote approaches. Together, we can advance medical treatments, enhance patient safety, and reshape the future of clinical research.