Clinical Trials and Protocol Development

Developing and implementing studies which enable the collection of data which support clinical and economic messaging of a new technology is imperative to market acceptance. Be it a single center, retrospective analysis of data associated with the use of a new technology or a full on randomized, prospective trial, there is a role for many types of studies as a part of your product development and commercialization pathway. Understanding what type of study is appropriate for your needs and how the study or studies can be conducted in an economic manner with the right investigators is critical.

While The Atticus Group is not a Clinical Research Organization (CRO) nor do we support the development and implementation of regulatory clinical trials, we do have experience working with clients to develop clinical marketing studies with medical devices and molecular diagnostics which support capturing and publishing data which conveys the clinical and economic value of these technologies. From assisting with protocol development, site identification, and the administrative logistics associated with initiating a study (IRB approval and institutional agreements) to the development of case report form and interacting with study investigators prior to and during the study itself, we have the experience that may align with your needs.