Biorasi has completed subject visits under Part A in a rare disease nephropathy study. With the “Last Subject Out” milestone taking place in April 2020, the clinical trial is now focused on Part B – the long-term extension phase of the trial. The final steps for completion of Part A of the study took place during the peak of the COVID-19 outbreak in March 2020.
“The COVID-19 pandemic created new challenges for Biorasi during the trial,” said Chris O’Brien, CEO of Biorasi. “Fortunately, our decentralized clinical trial solutions enabled us to integrate remote strategies into the existing study and maintain the timeline for trial stakeholders as well as patients.”
Taking Charge During a Health Crisis
The final project milestones for Part A of this basket trial were attainable, despite COVID-19 challenges, through quick intervention by the Biorasi project team.
“Understanding the challenges posed by COVID-19, the Biorasi team rapidly developed a successful strategy to meet the key project milestones during the peak of the pandemic,” said Hansi Kumari, Ph.D., Senior Project Manager at Biorasi. “We immediately began to brainstorm and develop impact mitigations for the study. The resulting decentralization strategy keenly focused on safety and risk, remote monitoring, timeline and milestone management, and budget management.”
Continuing Treatment for Rare Disease Nephropathies
Biorasi’s proactive strategy was put into practice to meet the final data delivery milestones during the peak of the COVID-19 pandemic. The program timeline was maintained, and Part A of the study was completed successfully and on time. At the end of the trial, subjects were given the option to continue with Part B (based on the recommendation of the Primary Investigator) and continue treatment, while other patients began a 24-week follow-up program that included clinic visits and safety assessments.
“We are honored to have been chosen by our partner in the search to find better treatment for individuals with rare and debilitating nephropathies,” said O’Brien. “We are also very proud of our Project Operations team in their successful application of decentralized solutions during the current healthcare crisis.
“Biorasi will continue to meet the needs of our sponsors and their patients in this difficult time through our innovative project management strategies and by leveraging key digital technology solutions.”
Explore the case study details for this rare nephrology trial.