The development of antimicrobials and vaccines over the last 70 years has played an important role in the fight against infectious diseases, but further clinical trials and research leading to the discovery and evaluation of new treatments are essential.

Read how our extensive experience can help you deliver results on time and on budget.

We deliver results on time and on budget so that you can develop the medicines and strategies that will combat current and future infectious diseases. We have extensive experience in immunization, public health measures, surveillance by health care professionals and treatments.

Our infectious disease clinical trial experience includes pediatric and adult trials at all stages of development for anti-infectives, including antibacterials, antivirals, antifungals and vaccines.

Our work in practice

  • >10 projects related to complex hospitalized infections targeting gram-negative pathogens
  • >10 Projects related to C. difficile infections including acute and recurrent disease
  • On time delivery of key milestones in vaccine trials in the past 5 years
  • Delivering vaccine trials for Ebola virus, Zika virus and other emerging health threats
  • Tackling gram-positive infections in acute bacterial skin and skin structure, endocarditis and osteomyelitis
  • Established pathways for early phase development in hepatitis and challenging Respiratory Syncytial Virus
  • Infectious Disease studies conducted throughout Latin America, Eastern Europe, Western Europe, Asia, Australia, Africa, North America
  • Dedicated Infectious Disease Therapeutic Area team including four Infectious Disease board certified physicians, microbiologist and operational teams.


Background

A customer asked us to project-manage and monitor a large-scale Phase III study assessing the safety of a combined vaccine in more than 2,000 infants at two sites in Mexico and Peru. The project posed particular challenges due to its setting, including lack of documentation to identify the legal representatives of the infants, subject retention, cold chain maintenance, and sample collection and handling.

Solution

We put together a dedicated team of CRAs who worked at the sites several days a week, to train and support site staff and perform ongoing data reviews. We also introduced extra quality control activities, such as secondary CRF reviews and co-monitoring visits with the customer.

Result

Recruitment was accomplished in only four months, and 2,003 infants completed the study (subject retention was 95%). The database was locked two months ahead of schedule, and the study was completed on time. As a consequence of our success with this study, the customer awarded us two additional projects.

Phase III

Subjects
 2,003

Sites 2

We are a market-leading CRO with extensive experience in all aspects of infectious disease clinical trials, from antibiotic pipeline to vaccine development. 

 

This is an estimate of INC Research studies from the last five years that are completed or scheduled to complete for this therapy area.