Even in the presence of careful planning, there are many factors that can present unanticipated challenges in clinical research, including the quality of CRO services, changes in business conditions, competition and investigator engagement. When a clinical research program is “at risk,” a coordinated effort to “rescue” the program with alternative or supplemental CRO services is often essential. Success in a rescue project requires that additional resources get up to speed and deliver targeted action almost immediately while collaborating effectively with all of the other parties engaged in the effort. Teams must also have demonstrated skill in the development and implementation of effective transition plans.

With broad experience in most therapeutic areas and the expertise necessary to move quickly to support at-risk clinical research programs, PROMETRIKA is the ideal service provider for rescue studies. Our team is positioned to rapidly assess all needs and develop and execute targeted plans of action including transition strategies to address any challenges effectively.  
Examples of recent rescue projects:

  • Our team took over clinical operations and data management tasks from a non-performing CRO engaged in two, phase 3 studies for a single sponsor, successfully completing all work ahead of schedule.
  • In an effort that required near-immediate turnaround, we were able to complete a comprehensive review and re-analysis of data sets supporting a NDA; our efforts included an essential re-write of ISS and ISE analysis plans.
  • For a sponsor who was required to execute a major reduction in staffing mid-stream during a clinical research program, we stepped in to provide a range of data management, biostatistics and medical writing services with the precise depth of clinical understanding and focus the sponsor required.