Case Study – Ten-Day Study Start & Customer Test Kit Build at the Height of a Pandemic

On the upswing of the COVID-19 pandemic, an ID focused pharmaceutical client of more than 10 years asked: Can you supply test kits and support for our new study in 10 days?

The client’s goal was to evaluate a previously approved drug for safety and efficacy in a new indication — as post-exposure prophylaxis for COVID-19 and other viral respiratory illnesses. 

Clearly, time was of the essence. Therapies to mitigate worldwide suffering were desperately needed. Approval was granted under the auspices of the FDA’s Coronavirus Treatment Acceleration Program (CTAP) for a Phase III study, which our client was anxious to initiate while the disease prevalence was building, and a study population would be easy to recruit.

For rapid study startup, our client needed custom kit building and distribution throughout North America along with database setup ASAP.