Data Management (Clinical Trial)
About Us
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.
EPS features
Huge Capacity
- 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
- Management skills that go beyond a single data management perspective and focus on the overall success of the trial.
High-Quality
- 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.
Services
- 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
- Coding
- 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
＜Applicable systems＞
- 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.