From the stage of protocol development till the stage of writing the final report the clinical data management team gets involved in all the aspects of the clinical trial process. CBS has developed and implemented number of data management systems that are widely used across the industry. These systems deliver high-quality outputs in industry standard formats and are easy to use because of their User Friendly nature. CBS provides storage space individually to users on cloud, wherein the user can keep his project-specific database and as such can have direct, on-line access. This allows the user to have interactive access to a project-specific database, allowing him on-screen generation of various status and exception reports, designed according to his specific requirements.
CBS has extensive experience of implementing data management systems in a broad range of therapeutic areas, using both paper and EDC systems. The Data Management group applies quality norms and procedures to complete complex clinical programs successfully. Resources trained by experts from CBS ensure that each study gets accomplished using efficient technologies. These are:
- CRF Design
- Database Design (Paper/EDC)
- Data Entry/Data Validation
- Medical Coding
- SAE Reconciliation
- Query tracking
- Medical Review
- Protocol Violations
- Data Mapping (CDISC)
- SDTM and AdaM
Key features of EDC:
- Fully customized, web based solution.
- Database deployment time less than three weeks with flexible server space allocation.
- Single log-on platform, and User friendly entry screen.
- Real time reporting and superior Clinical Trial Management.
- Intuitive interface for subject enrolment, clinical data capture, validation, and query management.
- Integrated tools for data cleaning, clinical data management, and site monitoring.
- Custom define and obtain clinical datasets in real-time, and in a variety of formats.
- Designate appropriate access for both site-level and study-level users.
- Tools for auditing (21 CFR part 11 compliant), configuration, and reporting.