Data Management (Clinical Trial)
Being one of the largest organizations in Japan with extensive expertise, we can propose the best plan for you.
Data management is the process of creating a database to collect data from medical institutions, organizing and checking the collected data, and deriving accurate data that can withstand statistical analysis.
- Quick and flexible response to changes in study plans with the largest scale of resources in Japan.
- Solutions that meet customer needs based on our ample resources of approximately 200 staff members and expertise in contracting.
- Management skills that go beyond a single data management perspective and focus on the overall success of the trial.
- Teams specialized in various systems such as eSource, CDASH, etc., use the PDCA cycle as needed to accumulate knowledge, training, and reflect it in SOPs and operation procedures.
- Based on the standardized procedures, we customize and optimize the procedures according to the customer's requests to ensure stable quality.
- CRF Design
- Paper CRFs and eCRFs screen design
- CDASH Services
- CDASH compliant CRF creation
- Data Entry
- Paper CRFs, reference values for clinical laboratory values, external data (paper media) digitization
- Data Review
- CRF data review and query handling
- MedDRA, Pharmaceutical Data Files, WHO Drug Dictionary.
- Form Creation
- creating materials for clinical conferences and various forms.
- SAS Datasets Creation
- Creating datasets to analyze.
- System Development and Operation
- EDC, remote medical system, eSource (DDC), eConsent, eCOA, ePRO, CDM system, external system, account management, help desk
- EDC: Rave EDC, Datatrak Enterprise Cloud, Viedoc, EDC Plus, CubeCDMS, Vault CDMS, etc.
- DDC: medrioDDC, beagle medica, etc.
- Telemedicine: MICIN MiROHA, etc.
- eConsent：Rave eConsent、SIGNANT HEALTH TrialConsent, medrio eConsent, etc.
- eCOA/ePRO: Rave eCOA/ePRO, ViedocMe, ERT, SIGNANT HEALTH TrialMax, SUSMED, medrio ePRO, etc.
- CDM System/External System: original systems.
- Application Approval Support
- Support to create EDS management sheets and conduct compliance inspections.
- Device Management
- Rental devices arrangement, management, and helpdesk support.
- Copyrights Representative
- License contract representative services for eCOA and ePRO.