Achieving Alignment on NIH-Funded Clinical Trial

Approaching its latest NIH-funded clinical trials, a university came to Pintail Solutions to help with their COVID-19 trials. Extreme challenges of managing multiple partners  and creating standardized processes, like SOPs and communication strategies, were creating urgent needs for fear of failure.

Through strategic interventions and robust communication frameworks, Pintail went on a rescue mission, not only to stabilize the current trials, but also set a strong foundation for future large-scale studies.

The university’s research arm for NIH trials received a significant grant to run COVID-19 trials in the midst of the global pandemic.It is largely integrated through its Clinical and Translational Science Institute (CTSI). This institute plays a significant role in conducting clinical trials and research funded by the National Institutes of Health (NIH) and provides infrastructure and support to facilitate clinical and translational research.

Challenge: Working with multiple partners, relationships were fractured and a lack of planning, resources, and structure put the success of the trials in jeopardy.

This 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 aimed to save lives and improve care for adult COVID-19 patients. 

These trials were launched with great urgency without adequate time to meticulously plan and without resources in place to execute. With a number of external partners in place and limited management, relationships became strained, accountabilities were unclear, and timelines were not being met. 

Facing increasing pressure to deliver and the university’s reputation at stake, Pintail Solutions’ experts were engaged to assist in stabilizing the trials.

Outcome: Increased enrollment, decreased time wasted in meetings, and more than 20 publications to create better alignment throughout the organization

Pintail Solutions' establishment of trust through peer-to-peer communication and collaboration among key operational groups maintained the integrity of conversations, kept team members engaged, and enhanced transparency through regular updates and meetings. They were able to decrease wasted meetings by 50% while increasing participation by 53%, leading to better 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 strong 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.

Solution: Using Pintail’s expert team to deliver a successful rollout of detailed, consistent communication patterns and efficient work solutions.

1. Defined Clear Roles and Responsibilities

Through a two-part initiative, Pintail established a formal ACTIV-4b Cross Disciplinary Clinical team, bringing together key representatives and team members regularly to oversee the study's progress. Then, they implemented organized oversight and communication practices to provide a structured approach to problem-solving and decision-making.

2. Relieved Conflict Among Partners

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.

3. Managed Work and Established Accountability

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.

4. Built Readily Accessible SOPs/Templates

Pintail Solutions worked with the university’s team to develop a case for investing in a document storage repository for approval and implementation by study leadership. Together, 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.

Positioned to lead the way for the future of NIH trials at the university

Pintail Solutions played a pivotal role in transforming the management of 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.