In the development of new drugs, the process of getting drug candidates into clinical trials is often very time sensitive. In a number of cases, setting expiration dates (use periods) for clinical materials becomes gating. At FreeThink, we have used our ASAPprime® software in conjunction with stability studies either in our laboratories or at the sponsor pharmaceutical/biotech company (or a combination of the two) to successfully speed the process of getting into early clinical trials. Here’s how:
Using this process, companies have reported that the following regulatory agencies have allowed the clinical trial to proceed without queries:
US, Canada, Bulgaria, France, Holland, Hungary, India, Italy, Japan, Philippines, Romania, Serbia, Slovakia, South Africa, Spain, Taiwan, Turkey, UK
There were queries/objections at the following regulatory agencies:
South Korea, Czech Republic, Ukraine, Germany
At FreeThink, we have the experience to work with internal regulatory leadership to develop an appropriate strategy for getting new chemical entities into clinical trials as fast as possible. We can also directly conduct the supporting cGMP studies in our laboratories.