Global Clinical Development Support

 
INDUSTRY
Pharmaceutical
SERVICES
Clinical Trial Planning
Clinical Trial Execution
SKILLS
Localization
Rare Disease
Three Phase II studies completed.
The Challenge

A global pharmaceutical company focused on treating iron deficiency, dialysis, nephrology, and rare diseases was facing difficulties with its clinical trials. They lacked the in-house knowledge in the niche areas they were targeting and required Medical Doctors (MDs) to sign off on portions of the trial. To avoid facing significant delays in their clinical trial process, the client reached out to Oxford Global Resources to assist. We had an existing relationship with this client supporting numerous clinical trials for therapeutic areas across the company, so they trusted us to provide the right talent for the initiative.  

The Solution

Over five years, we provided over 20 MDs with specific therapeutic area expertise to assist with the planning and execution of the clinical trials. These individuals were tasked with overseeing multiple clinical development processes and medical affairs tasks. In addition, they reviewed medical data before submission to the necessary regulatory bodies. These individuals needed experience with very niche areas of clinical development and the pharmaceutical industry, and they also needed to be aware of localization requirements, as the client wanted to bring their products to market in several different countries. Individuals provided included: 

  • Clinical Trial Supply Coordinators 
  • Scientific Medical Writers 
  • Clinical Development Consultants (MDs) 
  • Medical Directors 
  • DMPK/PKPD 
  • Clinical Trial Managers 
The Result

Oxford’s consultants successfully helped the client complete three Phase II studies and set up two Phase III studies with minimal disruption to in-house teams. As a result, the client’s internal employees could maintain their quality of work since they were not burdened with the additional tasks our team took on. The client has continued to seek our support for resources across other business areas – including regulatory, quality, medical affairs, clinical trial supply, and clinical operations.