Keeney Consulting is a specialized clinical research organization supporting medical device and biopharmaceutical sponsors through every phase of clinical development — from study design through regulatory submission.
Founded in 2008 by Jeff Keeney, Keeney Consulting started as a solo clinical consulting practice operating under the family name — and the domain we'd held since the early days of the internet. What began as a one-person operation supporting device startups with protocol design and regulatory strategy has grown steadily into a team of dedicated clinical professionals.
Today, we remain intentionally small. Our team of eight clinical operations, data management, and regulatory specialists partners directly with medical device and biopharmaceutical sponsors to deliver the kind of focused attention that larger CROs simply can't provide. We've kept the family name because it reflects what matters most to us: personal accountability for every study we support.
Headquartered in Charleston, South Carolina, we serve sponsors across the United States and have supported multi-site international studies across North America and Europe.
From first protocol draft to final study report, we provide the operational backbone that sponsors need to advance their clinical programs efficiently and compliantly.
We develop scientifically rigorous protocols optimized for regulatory success. Our designs reflect deep understanding of FDA expectations for IDE, PMA, and De Novo submissions.
End-to-end trial oversight including site selection and activation, enrollment management, monitoring strategy, and close-out. We operate as an extension of your team.
EDC system setup and management, data cleaning and query resolution, medical coding, and custom analytics pipelines. We deliver submission-ready datasets on time.
IDE and PMA submission preparation, pre-submission meeting support, and regulatory strategy consulting. We've supported over a dozen successful FDA submissions.
We evaluate, select, and manage critical study vendors including CRO partners, labs, imaging core labs, EDC platforms, and ePRO providers — negotiating contracts that protect sponsor interests.
Investigator identification, site qualification visits, feasibility assessments, and ongoing site relationship management. We leverage our network of clinical sites across therapeutic areas.
We don't operate behind a wall of project managers. When you work with Keeney Consulting, you work directly with the people doing the work.
We start by understanding your product, your clinical evidence needs, and your regulatory pathway. No templated proposals.
We develop a tailored clinical development plan and study design optimized for your specific regulatory and commercial objectives.
Our team embeds with yours to manage day-to-day operations, data oversight, and vendor coordination with full visibility.
Clean datasets, completed regulatory submissions, and a study report you can stand behind. We stay through the finish line.
Our team brings hands-on study experience in the following areas, with a particular depth in pulmonology and respiratory medicine.
Interventional & therapeutic
Devices & diagnostics
Surgical & implantable
Minimally invasive tools
Neuromodulation devices
Imaging & diagnostic AI
Advanced healing systems
SaMD & companion apps
Every member of our team brings 10+ years of clinical research experience. When you partner with us, you're working with seasoned professionals — not junior staff learning on your study.
Whether you're planning a first-in-human feasibility study or scaling up a pivotal trial, we'd welcome the opportunity to discuss how Keeney Consulting can support your goals.