Efficient data management accelerates the clinical trial process and ensures data consistency and accuracy.
Symyoo’s data management (DM) team's extensive knowledge and experience manages vast amounts of data generated by your clinical trials, while assuring the quality of data.
Symyoo’s full scope DM services cover from case report form (CRF) design to database lock and archiving, and also guarantee the timely delivery of quality clinical data.
The Symyoo DM SOPs and internal work guidelines ensure that the clinical data is completely validated and verified at every steps of data management process.
Symyoo’s DM team provides project-specific data collection instruments either using in-house developed EDC system, SYNeRA™, or other commercially available information systems in sponsor's behalf.
Symyoo has broad experience with designing and implementing biomedical/clinical information systems for single and multi-center research studies.
Data Management Services
Data Management Plan and Manual of Procedures Development
Study Visit and CRF collection Schedule
Case Report Form (CRF) Design
Data Validation Specification (DVS) Development
Data Quality Control: Data Query Generation and Follow-up
Medical Coding (MedDRA, WHODrug ATC Code, etc.)
Serious Adverse Event (SAE) Reconciliation
Centralized, Remote Data Monitoring
Database Freeze, Lock and Data Transfer
Data Management Reporting: CRF/Query Collection and Response Statistics
Integrated Trial Management System Solutions
Information System Development for Clinical Research
Architectural System Design and Development
Symyoo EDC system, SYNeRA™ for Clinical Research Data Collection and Management
Symyoo IWRS (Interactive Web-based Randomization System) and IP Accountability (Investigational Product Tracking and Management System)
Data Quality Assurance: Data Validity Check, Rule-based Validation
Data Entry Screen (DES) Development and Validation
Data Safety and Security Control: Data Encryption, System Authentication & Authorization, Data Backups & Archiving
21 CFR Part 11 Compliance: System Validation and Documentation