Infectious Diseases Trial Experience

The need for innovative antibacterials, antivirals, and vaccines to address serious global health issues has never been greater, creating significant market opportunities for biopharmaceutical companies developing novel anti-infectives.  At the same time, pivotal trials to test new infectious disease (ID) therapies are increasingly difficult to undertake, with challenges that include the complex regulatory environment governing the conduct of clinical trials for these products, and the difficulty of recruiting specific types of investigators and patients needed for infectious disease trials – especially for serious infections that must be treated in a hospital setting.  As a result, ID therapies can be difficult and expensive to develop.  To succeed, biopharmaceutical companies need an experienced ID partner to help steer their new anti-infectives and vaccines through the complexities of pivotal trials for. 

PAREXEL offers a wealth of experience conducting pivotal ID trials.  Over the past five years, we have actively participated in more than 280 ID studies involving nearly 91,000 patients, covering diseases such as HIV/AIDS, hepatitis B and C, pneumonia, skin infections, HPV, and septicemia.  PAREXEL has particularly broad experience with community- and hospital-acquired pneumonia, HIV, and preventative vaccines.  This work has also given us extensive expertise in Expanded Access Programs.

PAREXEL’s ID resources include a team of physicians and scientists with years of academic, clinical, and pharmaceutical industry experience developing ID therapies. In addition, we have approximately 90 project managers and 425 CRAs on staff with ID trial experience, plus a database of thousands of qualified ID investigators at sites in dozens of countries around the world.  This global infrastructure allows PAREXEL to more efficiently recruit treatment-naïve patients for our clients – an increasingly difficult challenge for ID trials.  PAREXEL draws on these same resources to help our clients recruit patients with specific types of infectious diseases that may be localized to certain geographic areas.  We also have a wealth of experience in conducting vaccine trials, with a team of clinical experts devoted specifically to vaccine studies.