Clinical Data Management & Biostatistics deliver superior-quality, efficient, cost effective solutions assures the trustworthy management and delivery of Clinical Trial study data. Our team manages and best of solutions for our clients that are especially designed according to their needs.
Our experience and understanding of Electronic Data Capture (EDC) processes and systems enables us to provide the optimum solution for each project. Our Data Managers are also trained in the use of the latest standards including CDISC. We employ these standards to enable efficient review, processing transmissions and submission of data to the regulatory authorities. Our proficient project team, is specialize with wide experience & processes in strict compliance to CFR Part 11. Moreover we established the facility, with adherence to sponsor and protocol specific requirements, to complete assignment on time. We employ these standards to enable efficient review, processing transmissions and submission of data to the regulatory authorities.
Clinical Data Management includes the following services:
- Quality Control and Data Quality Audits.
- Medical Coding, SAE Data Reconciliation
- Double Data Entry Comparison and Adjudication
- Query Management Database Lock & Export to SAS
- Clinical Data Management Report Database Design & Development
- Data Cleaning
- Edit, Validation & Design check programming
- Data Validation
- Project Specific CDM Plan
- Delivery of Clean Data Files & Documentation
- Project Data Archival & Storage
- Independent Double-Data Entry
Biostatistics includes the following services:
- Risk-Benefit Analysis
- Randomization/Blinding
- Sample Size Calculation
- Statistical Report Preparation
- Statistical inputs for Protocol Design
- Support DSMB/DSRB conduct an interim Analysis
- Statistical Analysis
- SAS Coding