To keep up with the high quality of clinical study data and to provide strict management on those data, we adopted Target e*Studio, Medidata Rave® and Oracle InForm as Clinical Data Management (CDM) systems that fulfill the requirements of FDA 21 CRF Part 11.
Our Data Management Team is composed of Clinical Data Associates (CDAs) equipped with medical expertise and Database Administrators (DBAs) equipped with IT specialty and they cooperate to provide high-quality data. We set up and operate the CDM systems and manage the operations of the CDM systems, which services help our clients to maintain the quality of the data throughout the study period from the time the CRF is developed until the study implementation is completed. Additional system services (IWRS, eDocument, Central Image system, Central Lab integration) that support the management of system operations are also available.
Concomitant medications and adverse events are coded using medical coding systems such as MedDRA, WHOART and WHODRUG/DDE. All of the coded adverse events and medications are to be reviewed by the Medical Director and the Pharmacist who are versed in medical coding systems and then they are finalized.
Our CDM systems’ set-up and operation as well as our CDM services and collected data are compliant with ICH requirements and the rules and regulations comparable to global standards. We also provide service of converting clinical data to CDISC/SDTM format, a standard format for clinical data, and we have experiences in regulatory submission of data in CDIS/SDTM format to US FDA.
LSK Global PS is a member company of the CDISC.
[Updated on June 30, 2018]