K&N Consulting has decades of experience with innovative product development and diligent clinical trial operations. We specialize in providing top-notch services for clinical trial management, program leadership/management, regulatory and clinical strategy, and day-to-day operations in all phases of medical device, in vitro diagnostics and life sciences projects. Whether you need a guide to perform road-mapping and planning, or a skilled subject matter expert to parachute in and fill an immediate role, or a seasoned industry veteran to turn-around an off-course project or clinical study, K&N Consulting can meet your needs.
Our team at K&N Consulting is made up of highly skilled professionals that have successfully worked with teams on complex projects and studies to overcome many challenges within the biotech industry.
We employ active listening and empower the team to work through any and all issues, while communicating clearly and effectively to all stakeholders.
At K&N Consulting, we take a holistic approach to life sciences consulting that factors in the voice of customer and regulatory requirements. We employ Agile methodologies for day-to-day activities; the Lean Start-up approach for iterating MVPs; Human Centered Design to define the nexus of technical feasibility, business viability and User desirability.
Our clinical operations approach leverages our deep experience to collaborate with your Clinical and Regulatory teams to create clinical study protocols, forms, reports, to monitor and manage the in-flight studies, and to coordinate with your Regulatory team, which ensures that the study endpoints are in line with your claims and Intended Use statements. End-to-end from User Needs to regulatory submissions.