Before drug sponsors can conduct clinical trials of new therapeutics in the U.S., they must first receive permission from the FDA. The vehicle by which that permission is sought is an Investigational New Drug (IND) application, and once it is submitted, drug development effectively ceases until regulators approve it. The main goal of an IND…

Drug development is a hyper-competitive industry, and pharmaceutical developers are increasingly turning to outsourced laboratory testing partners to gain an edge. Choosing the right partner can maximize efficiency and play a critical role in gaining regulatory approval quickly. Still, outsourcing critical research comes with an element of risk. It is crucial to vet research partners…