Project Management
Proactive project management for oncology trials—on time, on budget, and aligned with milestones.
Study Execution Support
Oncology-Focused PM Experts
The capability to proactively drive speed, innovation and productivity improvements 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 a deep investment in your study. The project management function will include coordination across Theradex to plan and prepare for a successfully operated study. Our experience spans most all indications and geographies.
Common aspects include:
Comprehensive Feasibility
Theradex’ 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. Your study start up associate will enable site feasibility and selection inclusive of selection and contracting to support the PM function.
Protocol Development/Study Design
Theradex’ 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.
Additionally, your experienced Project Manager will be your main point of contact for the duration of your study and will coordinate and draft:
- Risk Assessment Analysis
- Risk Based Monitoring Plan (if appropriate)
- Study Management to include protocol, teams, vendors
- Electronic Trial Master Plan (eTMF)
- Recruitment Plan and Monitoring Reviews
- Quarterly Contract Review Meetings/Steering Committee Meetings
Thank you for the excellent work your team did on our trial. In particular, I want to call out the Medical Monitor, Project and Associate Project Managers and the Site Contracts Manager.
Both PMs’ hard work and effort were 100% apparent in every meeting, the quality of the study related documents we received and their leadership of the study team, which is no easy feat with a complex trial such as ours. In addition, their professionalism and kind natures will always stand out to me and is what makes me recommend Theradex to other Sponsors. In fact, my only complaint is that Theradex is soley focused on oncology and I wish you would branch out into other therapeutic areas.
Overall, my experience with Theradex, because of this team, renewed my faith in CROs and they were truly a joy to work with them. I look forward to working with Theradex again, hopefully in the near future.