Whenever you seek a regulatory approval, you need a loyal and trusted partner on
your side. You need a company that you can trust to handle the data from your clinical
trials. STATKING staff has implemented SOPs for a broad spectrum of clinical trial
services from protocol development to clinical study report writing that meet or
exceed all federal guidelines. STATKING has been audited by FDA and passed with
Whenever you seek a regulatory approval, you need a partner who understands the intricacies of FDA submissions. The STATKING staff has worked on numerous types of FDA submissions, as well as, submissions to regulatory authorities outside the US. For NDAs, BLAs, PMAs, and 510Ks, STATKING expertise on the electronic and data Components (eCTD, CDISC, SAS, XML) of these submissions sets it apart from other CROs. STATKING has never received a refused to file FDA on any of its submissions.
Whenever you seek a regulatory approval, you need statistical expertise on your
side. You need statisticians who work on clinical trial design and analysis issues
on a daily basis. STATKING's staff of Ph.D. statisticians have interacted with FDA
committees to determine the appropriate statistical methods needed to produce protocols,
interim analysis plans and statistical analysis plans that align the expectations
of the client and the agency.