Project Management

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:

  • Comprehensive Feasibility Studies: Theradex’s history of cancer specialization means that we have worked extensively with large academic cancer centers as well as community based centers across the United States, Europe and Asia.  As a result, Theradex has expertise in site selection as well as a set of metrics to estimate study start-up times for each institution. The feasibility questionnaire is customized to collect logistical information based on the protocol design to aid in protocol development/study design and increase the speed of early oncology trials
  • Protocol Development/Study Design: Theradex’s experienced project management staff as well as our on-staff oncologists offer their expertise to ensure a protocol designed to address the key study endpoints in the most efficient way possible. 
  • Presentations/Publications/Abstracts: Theradex has the capability to develop ad hoc and planned presentations, publications, and abstracts for Sponsor’s to present at conferences or other public forums.
  • Risk Assessment Analysis: Theradex performs a thorough risk assessment of each study in order to preemptively address items that are critical to quality of the data for the study endpoints.  The risk assessment analysis drives study design, study plan design, and site training. The risk assessment analysis is updated on a quarterly basis after discussion with the sponsor.
  • Risk Based Monitoring: Theradex has employed Risk Based Monitoring Approaches since 1985 to well-qualifying studies.
  • Quarterly Contract Review Meetings/Steering Committee Meetings: Theradex’s Board of Directors review contracts and the status of each study on a quarterly basis.  These meetings also welcome Sponsor participation.