Clinical Data Management Services (CDMS)
We offer an end-to-end Clinical Data Management solution encompassing:
- Protocol Design and/or Review
- CDISC/CDASH Compliant CRF/eCRF Design and Maintenance
- Database Configuration and Building
- Programming of Data Validation Checks
- Development of Data Management Plan and other documents creation
- Data Entry (Single/Double)
- Utiliation of eSource and ePRO/eCOA
- Data Cleaning and Query Management
- Transfer and Reconciliation of External Data
- Medical Coding using dictionaries MedDRA and WHO Drug
- SAE Reconciliation
- Custom Status Report Development
- Implementation of Quality Management Procedures
Electronic Data Capture Experience
Our team is proficient across various EDC systems, including systems Medidata Rave, Veeva Vault, Medrio, Inform, as well as lower cost systems. This allows you to choose the perfect system for your trial size, budget, and preference.
Integrating Data for Improved Efficiency
We have Veeva Vault and CRScube as qualified vendors for CDMS, that seamlessly integrate with ePRO, eIXRS, e PV, CTMS, eTMF. This integration establishes a unified ecosystem, enabling real-time access to clinical trial data for efficient management, quicker decisions, and better results.
Statistical Programming and Biostatistics
Our team of biostatisticians and statistical programmers provides support across all phases of the development lifecycle, expediting timelines, mitigating risks, and enhancing the decision-making process. Covering everything from study design to regulatory submissions, our solutions span the spectrum of biostatistical and programming encompassing:
- Study design and endpoint strategies
- Adaptive design, randomization methods and schedules
- Statistical analysis planning and strategies
- CDISC standards implementation
- Analysis Datasets and TLFs Development
- Safety and efficacy analysis
- Statistical Report
- Regulatory submission support
- Quality Control and Validation