Press Room

November 8, 2009

The US Food and Drug Administration has awarded FEFA the contract to provide the development of a web-based, metadata driven software tool for clinical protocol review.

 

August 1, 2009

FEFA has been awarded a contract to provide 508 compliance services to the US Food and Drug Administration.

 


Clinical Monitoring

Our dedicated clinical teams of skilled professionals provide consistent and effective monitoring and interaction with study sites.

FEFA can provide full project management and monitoring or a team of monitors. FEFA monitors have experience across various phases of development and a variety of therapeutic areas. All monitors undertake mandatory training on SOPs, along with training on Sponsor-specific protocols and SOPs before beginning work on any study.

FEFA has the capability to ensure that clinical trials to evaluate efficacy and safety of pharmaceutical products are conducted scientifically and in adherence to GCP requirements, various regulatory guidelines, as well as proper ethical consideration to patients.

Monitoring offerings:

  • Pre-Study Visits
  • Site Initiation Visits
  • Routine Monitoring Visits
  • Close-Out Visits
  • Clinical Supply Management
  • Essential Document Management
  • Trip Report Review Tracking
  • Co-Monitoring
  • Data Management
  • Query Resolution
  • CRF Review
  • Project Management
  • Study Rescue