Solutions for Non-Remote Trials
Your Research understands the significance of streamlined data management in clinical trials, even when conducted in non-remote settings. Clinical trial software plays a crucial role in efficiently managing, analysing, and reporting the vast amounts of data generated throughout the trial process. In this case study, we explore how Your Research’s clinical trial software drives success in a non-remote clinical trial.
Background: Advancing Rare Disease Drug Development
A pharmaceutical company, a renowned biotech company specialising in rare diseases, embarked on a phase II clinical trial in 2020. Their goal was to evaluate the safety and efficacy of a groundbreaking drug for a rare genetic disorder. The trial encompassed 100 patients across 20 sites spanning the United States, Europe, and Asia. Following a randomised, double-blind, placebo-controlled design, the trial spanned a 12-month treatment period with a subsequent 6-month follow-up period.
Solution: Your Research's Modular Clinical Trial Management System (mCTMS)
Recognising the need for efficient data management, the pharmaceutical company embraced Your Research’s mCTMS to streamline trial operations. Your Research offered modules tailored for patient management, data capture, and data analysis, empowering the pharmaceutical company with a comprehensive solution. Notably, the Your Research CTMS was fully validated and compliant with regulatory requirements for electronic records and electronic signatures, ensuring the integrity of trial data.
Regulatory Compliance and Streamlined Reporting
Your Research’s software solution played a pivotal role in ensuring the pharmaceutical company’s compliance with regulatory requirements throughout the trial. The system featured built-in data validation checks and audit trails, safeguarding the integrity of the trial-generated data. Moreover, the software provided automatic reporting and data export functionalities, simplifying the generation of reports and seamless submission of data to regulatory authorities.
Results: A Successful Clinical Trial
The pharmaceutical company achieved resounding success, meeting all primary and secondary endpoints within the clinical trial. The seamless integration of Your Research’s software played a significant role in facilitating this success, empowering efficient data management and real-time monitoring capabilities. The software’s compliance features enabled DAN Pharmaceuticals to navigate regulatory requirements effortlessly and generate reports promptly.
Conclusion: Streamlining Data Management in Non-Remote Clinical Trials
Clinical trial software, as exemplified by this company’s experience with Your Research’s software solution, serves as a catalyst for efficient data management throughout the clinical trial journey. The mCTMS solution provides pharmaceutical companies with efficient data management, real-time monitoring, and regulatory compliance capabilities. Embracing clinical trial software equips pharmaceutical companies with a powerful toolset, enabling the development of safe and effective drugs.
Partner with Your Research to unlock the full potential of streamlined data management in your clinical trials, revolutionising the way you develop life-changing treatments.