Data Management

Data Management

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

Excellent DM Experts and System Support

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.

High-quality Data Management complying with global Regulations

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.

Prompt and efficient Rescue Services

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.

Process

Well designed eCRF & build-up
  • Data management plan
  • CRF-development
  • Design of CRF contents
  • Data valiation plan
    1. - Edit checks specification
    2. - Edit checks programming
  • System test
Qualified operational service
  • Data entry
  • Data management
  • Status management
  • Medical coding
  • Query management
  • External data reconciliation SAE reconciliation
Standard data format
  • Data quality check
  • Database lock
  • Close/Archiving/Dataset transfer

Service Scope

Clinical data management

  • CRF development/eCRF(Electronic Case Report Form) design
  • Database design and study setup
  • Medical coding with industry standards(MedDRA/WHODrug Global) and client-specific dictionaries
  • Reconciliation of serious adverse events(SAE) and external data
  • Integration of external data(lab data, core lab data, etc.)
  • Project management of data quality and technical services
  • Consultation of data management strategies, systems, procedures, and metrics

IRT(Interactive Response Technology)

  • IWRS / Randomization services
  • Drug supply and inventory management
  • Real-time online management reports
  • Integrated third-party electronic data vendors

Global standard data format

  • Data consolidation, migration, mapping and conversion of legacy data into CDISC/SDTM compliant datasets including Define.XML file

Experience

Study Types

180160140120100806040200 Phase I Phase II Phase III Phase IV IIT PMS Observation Study Epidemiology Medical Device Bridging Study Others

Therapeutic Area

640 Projects (Updated on 2019.12.31) Cardiovascular Oncology Endocrinology Neurology Gastroenterology Urology Orthopedics Vaccine Respiratory Rheumatology Others