Korea’sLeading CRO LSK Global PS

Establishes LSK SMO as Separate Corporation

Korea’sleading contract research organization (CRO) LSK Global PS (LSK Global PharmaServices Co., Ltd.) announced on April 18, the establishment of LSK SMO as aseparate corporation. Having been separated from the CRO and established as aseparate corporate body, LSK SMO, as the first domestic site managementorganization (SMO), together with the existing CRO, is expected to not onlyprovide even more specialized services but also firmly lay the foundation forcompetitiveness and professionalism at global level.

Although since 2013 LSK SMO has provided support for observational studySMO services while attached to LSK Global PS, after its current incorporation,LSK SMO, as a domestic organization, is covering the role of the CRC, and isperforming the work entrusted to it by training the Site Management Associate(SMA), which is in charge of the duties of overall site managementorganization.

Althoughcurrently, the CRC’s frequent changing of responsibilities is recognized as amajor problem for domestic contracted research centers, SMO services can not only solve problems like the CRC’s changing responsibilitieswith the stabilized SMA manpower, but also improve the quality ofclinical trials.

Further, inregards to previous SMO services attached to CRO, contradiction existed inunderstanding the relationship between data integrity and ethical management inclinical trials caused by the difficulty of independently managing SMO tasksfrom CRO. Thus, separate management of CRO and SMO is crucial in drawing andproviding professionally as well as ethically secured clinical study results.

 Young-jak Lee, the CEO of LSK SMO said, “SMOstarted with the goal of expanding the scope of benefits made possible byclinical trials, but now its role is steadily expanding,” and also commented “thisestablishment of LSK SMO as a separate corporation will make specializedCRC(SMA) manpower training possible and will be an opportunity for domesticclinical testing to advance to the next step.” Then he added, “LSK SMO,together with LSK Global PS, will continue to introduce even more advancedclinical trials management systems to secure the professionalism of the localclinical trials industry and to do all that is possible to help the domesticpharmaceutical industry enter the foreign market.”