LSK Global PS develops and provides ethical and scientific protocols for various studies including phase 1∼4 clinical studies on medicinal products and clinical studies on medical devices, human studies of health functional foods, observational studies, and post-marketing surveillances. After a clinical study is completed, LSK Global PS also prepares the clinical study report including the considerations on its statistical analysis results and clinical implications.
LSK Global PS is staffed with medical writers having a master’s or higher level of education with a broad spectrum of experiences in clinical studies on various diseases and managers with at least 10 years of experience in medical writing in average, who develop clinical study designs and protocols cooperatively, and expert statisticians who calculate the number of subjects and prepare the statistical analysis plans. They provide high-quality study designs and statistical methodologies through close communication with the internal teams such as Statistical team, Clinical team, and Data Management team.
LSK Global PS prepares protocols, ICFs (Informed Consent Forms), CSRs (Clinical Study Reports), and CTDs (Common Technical Documents) in compliance with the regulations and guidelines of the ICH, FDA, and MFDS of which the quality control (QC) and reviews are carried out by the medical writing manager, and provides high-quality outputs in which medical knowledge and evidence have been reflected through consultation with its affiliated medical doctors, as needed.