Data Management & Smart Trial Solutions

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