A large, nationally renowned research university was awarded over $100 million in NIH funding to lead a trio of Phase 3 clinical trials involving COVID-19 patients. These trials, collectively known as the ACTIV-4 Antithrombotics, aimed to explore the use of blood thinners in saving lives and improving care for adult COVID-19 patients at risk of developing life-threatening blood clots. Launched with urgency, the trials lacked meticulous planning and adequate resources, leading to strained relationships, unclear accountabilities, and missed timelines. Pintail Solutions was engaged to stabilize and guide these trials back on track.
Pintail Solutions addressed this issue through a two-part initiative. First, they established a formal ACTIV-4b Cross Disciplinary Clinical team, bringing together key representatives and team members regularly to oversee the study's progress. Second, they implemented organized oversight and communication practices to provide a structured approach to problem-solving and decision-making.
To remedy internal conflicts, Pintail Solutions conducted one-on-one meetings with key stakeholders and team members to discuss current actions, issues, risks, and concerns. This approach aimed to build mutual trust and understanding, fostering strong relationships with all vendors and operational teams. By implementing a robust communication framework, Pintail Solutions enabled effective development of ACTIV-4 partnerships.
Pintail Solutions restructured ACTIV-4’s core meeting structure and implemented an escalation workflow to bring decision-makers together. This effectively addressed issues and accelerated the execution of action items. Diligent tracking of timelines, milestones, and outcomes, coupled with a proactive approach, allowed Pintail Solutions to close the ACTIV-4b trial successfully and on time.
Pintail Solutions developed a case for investing in a document storage repository for approval and implementation by study leadership. They also created new SOPs and best practice templates to assist study personnel, enhancing the University’s readiness for future funded studies. By assessing existing SOPs and processes, Pintail Solutions implemented updated procedures to mitigate inefficiencies, address gaps, and reduce potential risks.
Pintail Solutions' establishment of trust through peer-to-peer communication and collaboration among key operational groups has yielded multiple benefits. This approach maintained the integrity of conversations, kept team members engaged, and enhanced transparency through regular updates and meetings. This led to a comprehensive understanding and timely resolution of issues and concerns by those actively involved in daily operations.
Pintail Solutions continues to partner with all stakeholders and functional teams to promote best practices, implement process improvements, and celebrate wins. This collaborative effort has fostered stronger working relationships across the board. As a leading NIH-funded research university, the institution is now well-positioned to confidently surpass expectations for future funded trials.
Pintail Solutions played a pivotal role in transforming the management of NIH-funded COVID-19 clinical trials, overcoming significant operational challenges to deliver timely and successful results. Their strategic interventions and robust communication frameworks have not only stabilized the current trials but also set a strong foundation for future large-scale studies. With enhanced processes and strengthened relationships, the university is now equipped to lead in clinical research excellence.
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