Infectious Diseases Case Studies |
Infectious Diseases: Anti-infective
INC Research successfully completed 15 anti-infective trials and submissions for one product, a quinolone, over the course of ten years. These studies were all conducted on time and on budget and over 40% of the trials were finished with enrollment prior to the targeted timelines. All the studies were full service projects including submission and liaison work with the FDA. The repeat business from this client is a testimony to the quality of work and timeliness of approvals from the regulatory agency. INC Research is currently now working on the next two anti-bacterial's for this client.
Infectious Disease: Chronic Bronchitis
Our Infectious Disease (ID) team provided full services for a global Phase III trial in Acute Exacerbations of Chronic Bronchitis (AECB), groundbreaking because it was the first of its kind conducted under the new FDA guidelines. It was a rescue study due to slow subject recruitment and low evaluability rates, which threatened to increase the required sample size. Stepping in for another CRO, we ensured the appropriate subjects were enrolled, which afforded the customer every opportunity to show superiority of their drug as compared to placebo. Enrollment increased more than two fold in less than half the time. The quality of data and evaluability rate also increased. Using our ID expertise, global reach and The Trusted Process the study achieved a QualityFinish. The customer was able to submit results at a key scientific meeting.
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Case Studies
Infectious Diseases: Anti-infective
Infectious Diseases: Chronic Bronchitis
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