Project-based clinical research assistance

Running a clinical trial or program involves several moving parts and teams working together in harmony.  Without synchronization of these teams, your clinical trial can fall off course and slow down the development of your compound.  Inadequate oversight can be a costly mistake.  

Project Management services

contact for Project management

 

Project management

With my flexible and affordable project management service options, I can provide:

  • High level oversight to a trial or manage specific teams & tasks.

 

My clinical trial operations management service can make sure all teams and vendors are providing accurate data in a timely manner.  Or, I can also focus on specific trial tasks such as:

  • Writing serious adverse event (SAE & AE) narratives, consent forms, study manuals, and case report form data entry instructions
  • Managing data flow from outside vendors and/or from the clinical site
  • Reviewing monitor/CRA trip reports
  • Managing regulatory documents
  • Training of clinical staff members (on electronic data capture systems or on trial related procedures)
  • Source document creation


Sponsors, CROs, and clinical vendors can all take advantage of my services.  By doing so, your company will benefit by having an efficiently run clinical program, where data integrity is protected and timelines are met.  I offer cost-effective short-term/long-term contracts, and I can typically perform these services as a home-based employee.  I can also travel to your company periodically for training and team meetings.