Human Challenge Study Services in Drug Development
With the evolution of increasingly more virulent viral diseases, increasing complexity of managing chronic diseases, and growing pressure to deliver safer, more effective treatments at a faster pace, current processes are no longer sufficient. You need to understand the disease progression and human response in more detail early to improve respiratory drug development time, costs and efficiency, including trial design, dosing regimens, and safety profiles.
With more than 15 years pioneering the use of viral challenge studies in respiratory and infectious disease early drug development, hVIVO brings a wealth of capabilities and know-how to help you do just that. With our standardized processes, controlled settings and infection control, pharmaceutical grade viruses, and hVIVO platform, you can monitor the entire disease lifecycle as subjects move from healthy to sick and recover back to healthy again, obtaining the detailed time course data to help prove efficacy sooner.
hVIVO offers challenge study services in:
Proven track record for broad range of therapies
hVIVO has pioneered the use of challenge studies in respiratory disease research over the past 15 years, conducted dozens of human challenge studies and authored over 100 publications. hVIVO challenge studies have been used to study the efficacy of a wide range of therapies such as antiviral drugs and vaccines as well as novel therapeutic drug classes such as immunomodulators.
Designed to find answers
With models available for flu, RSV, HRV, and asthma , you can test a variety of therapies in development. By using lower inoculum and optimized symptomology, our human challenge studies are designed to mimic normal disease patterns and hence can provide a greater degree of precision about drug effects, safety profiles and dosing regimens, reducing time to market. In addition, including challenge studies as part of your early development helps you to:
- Gain valuable information to guide both drug development and program development
- Identify and qualify biomarkers to assist in assessing drug response, a key component of stratified medicine approaches
- Prioritise promising therapies for accelerated development
Obtain expert designed, efficient studies delivered quickly
hVIVO experts have designed more than 50 studies with over 2,500 volunteer and utilizes a standardized study process. Our study management processes and services are tightly coordinated from start to finish to deliver quality study results on time and in lock step with your needs:
- We integrate data-driven processes, in-house volunteer recruitment, dedicated project management, and onsite sample analysis capabilities with tightly aligned oversight
- Along with a dedicated project management team to serve the needs of your study, we have the ability to mine 15 years of trial data to better guide you on trial design and help ensure your study is delivered quickly, typically in under 12 months, and ontime
- In addition, through our in house recruitment team (FluCamp), hVIVO brings experience and know-how for successfully recruiting subjects across a variety of target populations; from healthy patients to the complexities of finding Asthma Patients with varying GINA types. We have developed a tightly managed volunteer workflow and very successful ‘FluCamp‘ experience to recruit volunteers into trials that meet your study needs
For more information on our viral challenge services, or to make a specific research or collaboration enquiry, please use the Contact Us form.
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