Who We Are
Clinical programs can stall, drift, or expose sponsors to unanticipated risks without proper planning and oversight. Marram Clinical Solutions was founded to help MedTech sponsors avoid these issues by providing consulting services that navigate the complexity of clinical development with confidence, clarity, and experienced leadership.
With more than 25 years in the clinical trial industry, we bring a practical perspective to study planning and execution—one grounded in experience, quality, and an understanding of where programs most often encounter risk. Our work spans early development strategies through active study oversight, with a focus on fit-for-purpose execution, strong governance, and regulatory alignment.
Like marram grass strengthens and stabilizes coastal landscapes, Marram Clinical Solutions helps reinforce clinical programs against unanticipated challenges. Through proactive planning, hands-on oversight, and thoughtful risk management, we support sponsors in building trials that are resilient, compliant, and positioned for success.
We work collaboratively with sponsors and their partners, offering independent insight, steady leadership, and a commitment to doing what is right for the program—and ultimately, for patients.
About the Founder
Cari Kniola is the Founder of Marram Clinical Solutions and a seasoned clinical research leader with more than 25 years of experience supporting clinical programs across development strategy, trial oversight, and execution. She started Marram Clinical Solutions to help MedTech sponsors avoid trial pitfalls she has witnessed throughout her career that could have been avoided with the right planning and governance.
Cari has spent her career working alongside sponsors and their partners to bring structure, foresight, and steady leadership to complex clinical programs. Her expertise lies in anticipating risk, strengthening governance, and ensuring clinical trials are designed and executed in a way that is both compliant and fit for purpose. She is known for her practical approach, clear judgment, and ability to guide teams through ambiguity without losing focus on quality or outcomes.
Cari’s experience spans multiple therapeutic areas in early development through pivotal and post-market phases, with a consistent focus on operational quality, regulatory integrity, and execution. She has built and scaled clinical trial operations teams from the ground up—hiring and mentoring talent, establishing SOPs and KPIs, and creating processes that are practical and scalable. She brings expertise in cross-functional trial operations and the practical application of ICH GCP/FDA/regional requirements for U.S. and global studies. She regularly partners across clinical, regulatory, quality, data, and commercial groups to align strategy with execution and keep programs moving forward.
Cari resides in ‘The Region’ of Northwest Indiana, neighboring the Indiana Dunes State and National Parks on the shores of Lake Michigan, where she often hikes and relaxes along the backdrop of the marram grass-lined lakeshore.
Marram Clinical Solutions was founded to provide MedTech sponsors with independent, experience-based support—bridging strategy and execution while reinforcing clinical programs with proactive planning, strong oversight, and regulatory alignment. Cari works collaboratively with sponsor teams to help build resilient trials that can withstand challenges and move forward with confidence. She is passionate about helping organizations develop and conduct quality clinical programs and bringing clarity and consistency to complex trials.
Cari Kniola, Founder and Principal Consultant
Contact us
Ready to build a stronger, more resilient MedTech trial? Let’s talk.