Site Monitoring & Management in a Clinical Trial of a Spatial Repellent for Vector-Borne Disease Control

  • Post author:
  • Post category:

The FHI Clinical project team supported site monitoring, site management and project management to assist the University of Notre Dame investigators achieve a level of rigor not typically required for a non-medical product in their double-blinded, randomized-cluster, placebo-controlled clinical trial of a spatial repellent against mosquitoes for malaria prevention.

Continue ReadingSite Monitoring & Management in a Clinical Trial of a Spatial Repellent for Vector-Borne Disease Control

Our Clinical Trial Experience With Ebola Virus Disease

  • Post author:
  • Post category:

Since 1976, Ebola virus disease outbreaks have primarily occurred in eleven countries: Democratic Republic of the Congo, Gabon, Guinea, Liberia, Mali, Nigeria, Republic of Congo, Sierra Leone, Sudan and Uganda. Although it is generally rare, it is often fatal, with death rates ranging from 25 to 90% in past outbreaks (average case fatality rate, 50%). No treatment or vaccine is currently approved, but there are several promising vaccines and treatments under development.

Continue ReadingOur Clinical Trial Experience With Ebola Virus Disease

Providing Site Monitoring and Management Expertise in Malaria Vaccine Trials in Equatorial Guinea

  • Post author:
  • Post category:

Data monitoring strategies implemented by our bilingual CRA helped eliminate the backlog to ensure timely database lock in a phase 2 trial for Sanaria's innovative PfSPZ Vaccine for malaria in Equatorial Guinea, an area with limited prior research experience.

Continue ReadingProviding Site Monitoring and Management Expertise in Malaria Vaccine Trials in Equatorial Guinea