LSK Global PS provides a full service for the data management regarding the configuration, operation, and management of the CDM system, starting from the development of the CRF(Case Report Form). Based on the data management experiences in various therapeutic areas, LSK Global PS provides efficient and specialized services in the collection and management of the clinical data obtained from Phase I~IV studies, OS(Observational Study), IIT(Investigator Initiated Trial), and PMS(Post-Marketing Surveillance).DATA_MANAGEMENT_BROCHURE
To generate the high-quality data, LSK Global PS develops the CRFs, and constructs and operates the CDM system by organizing CDAs(Clinical Data Associates) with medical expertise and DBAs(Database Administrators) who are IT experts into a team, and supports the additional systems(IWRS, eDocument, Central Image system, Central Lab integration) needed for this.
LSK Global PS owns the largest manpower with Medidata Certification and MedDRA Coder Certification in Korea and has been recognized for excellence in its CDM staff by getting certified as the first CCDM® Industry Partner by the SCDM in 2019 among the domestic CROs providing full services for clinical trials.
* The CCDM® Industry Partner is a certification granted to a company which has striven for the data management of clinical studies and the obtainment of the CCDM and gets accredited to the company 25% of which the CDM(Clinical Data Management) is the CCDM® at least or in which at least 10 persons have obtained the CCDM®.As of the year 2019, only the 17 companies including LSK Global PS have been certified as the CCDM® Industry Partner among the more than 2,200 SCDM member companies all over the world.
LSK Global PS is implementing the Target e*Studio and the Medidata Rave® system as the Clinical Data Management system satisfying the criteria of the FDA 21 CFR Part 11 for the high quality and strict management of clinical trial data. LSK Global PS is supporting the classification coding with the Medical coding(MedDRA, WHOART, WHODrug GLOBAL DICTIONARY) to classify the concomitant medications and disorders, and Coding Support System. All of the classified AEs and medications are finalized after reassessment by the medical director and a specialist pharmacist.
The configuration and operation of the CDM system, CDM services, and data are all compliant with the criteria of the ICH, and the regulations and criteria of the global level requirements. LSK Global PS is providing the service of data conversion into the CDISC/SDTM formats which are the standards for clinical trial data and has an experience of submitting the clinical trial data to the US FDA by using the formats of the CDISC/SDTM which are the standards for data submission.
When the problems such as the issues causing a delay in the timeline or any problem in terms of the quality and efficiency of the clinical study being managed by another company arise, LSK Global PS can find out the reasons for such problems based on the know-hows accumulated through its experiences in the data management of diverse clinical studies and provide solutions for them in a prompt and efficient manner.