Case Study: Delivering on Milestones in the COVID-19 Crisis

Background

Starting with initial reports in December 2019, the COVID-19 virus quickly spread to pandemic proportions by March 11, 2020. Due to the threat of virus transmission, quarantine, social distancing, and shelter-in-place orders were initiated. The result was the closure of many businesses. This included clinical trial sites, leading to the shutdown or delay of multiple existing and projected clinical trials.

The Biorasi Project Team were focused on the completion of two critical project milestones which were suddenly put at risk due to the COVID-19 health crisis.

Challenges

Due to the COVID-19 quarantine, a key Biorasi client was facing delays in an ongoing basket trial –obstacles that would upset the trial timeline and lead to potential interruptions in treatment as well as unexpected budget overruns.

The first milestone was focused on meeting the data delivery goal for six months of treatment data for the C3G patient cohort, one of the rarest of the four diseases in the basket trial. Challenges included:

• Site restrictions on monitoring visits
• Closure of some sites, leading to the cancellation of patient site visits
• Clinical Research Coordinators (CRCs) without site access requiring remote solutions

The second milestone – also part of the C3G cohort – was focused on meeting the data delivery goal for 12 months of treatment. Challenges included:

• Pending patient study visits
• Timeline for data cleaning and reconciliation
• Vendor and site alignment for delivery of data

Solutions

Understanding the potential challenges caused by COVID-19, the Biorasi Team immediately began to brainstorm and develop impact mitigations for the study. The resulting management strategy keenly focused on safety and risk, remote monitoring, timeline and milestone management, and budget management.

This proactive strategy was put into practice to meet the first data delivery milestone during the peak of the COVID-19 pandemic. Additionally, the Biorasi Team leveraged the successful outcomes of the mitigation strategy to plan and complete the second milestone in the project.

Milestone #1:

• Requested specific dates from site CRCs for query resolution/remote source data verification (SDV)
• Facilitated close alignment between data management and clinical teams to resolve all site issues in the presence of CRCs
• Ensured sites with no CRC access were reported to the client immediately and removed from the dataset

Milestone #2:

• Nurse Service Management: Expedited alignment and document review for home nursing services to ensure availability as backup in case the site visit was affected
• Site alignment: Promoted close site alignment and communication for the following tasks:
  • Completed Last Subject-Last Visit (LSLV) within visit window
  • Tracked site visit, Electronic Data Capture (EDC) updates, and coordination of sample shipments
  • Executed remote monitoring plan/schedule to meet the query closing/SDV requirements for the data delivery
• Vendor alignment: Coordinated with central lab to ensure completion of the following tasks:
  • Expedited delivery of lab kits to home nursing services
  • Expedited transfer of LSLV data to be reconciled for data cleaning required for the milestone

Results

With the impact mitigation strategy in place, Biorasi was able to meet both data delivery deadlines – keeping the trial on track and completing the first part of the study despite operational challenges caused by the COVID-19 crisis:

“The complications posed by COVID-19 were new to me and my team. As a Project Manager, I have never faced anything similar before. Fortunately, Biorasi was able to rise to the challenge. Thanks to our phenomenal project team, we were able to brainstorm and execute a mitigation plan seamlessly and in record time. We cannot have completed the study on time without their commitment and dedication.”
– Hansi Kumari, Ph.D., Senior Project Management