Theradex is a scientifically oriented organization and employs scientifically trained talent within the Clinical Operations staff to ensure comprehension of technical and clinical issues during sponsor interactions, while training and communicating with investigational site personnel, and while conducting the clinical trials. The current project leads for Clinical Operations have graduate degrees in bioengineering, chemistry, molecular biology, pharmacology, nursing and public health. Most Theradex site monitors have graduate science degrees or have experience as study coordinators or study nurses at cancer centers. Additionally, the project team includes a full-time Theradex oncologist from the time of trial inception who helps guide the scientific and clinical discussion through ongoing team training and discussions of topics relevant to the investigational agent, study design and clinical events that occur during the trial.
The capability to proactively drive the speed, innovation and productivity improvements described above are qualities that all Theradex Project Managers possess. To ensure that the Theradex Project Manager assigned to a study will readily satisfy the Sponsor’s expectations, we align the trial with a Project Manager’s experience, background and interests so that they develop an investment in the study. In addition, Theradex’s Steering Committee Governance process ensures that any potential project issues are identified early so that the issue can be either prevented or addressed proactively. Theradex invites a Sponsor representative to participate in these Steering Committee meetings and to provide feedback on the Sponsor’s perception of the current status of their study as well as the performance of the Project Manager.
Our Current Project Management/Clinical Operations Services: