Process Expertise

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 no findings.

Sumission Expertise

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.

Statistical Expertise

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.