- Overview
- Our Capabilities
- Why Choose Us
Overview
With extensive experience and deep industry expertise, our company specializes in delivering top-notch, timely, and affordable data management, biostatistics and programming services to bolster clinical development and regulatory submissions. We are committed to providing flexible, reliable, and efficient solutions to meet the unique needs of each client. If you have any need, please contact us.
Our Capabilities
Data Management Services
- Dictionary management after coding
- Risk based quality management
- Case report form (CRF) design based on CDASH
- Database design, development, and maintenance
- Medical coding
- Study risk monitoring centered quality control
- IRT databases build-up and navigation
- External data handling and reconciliation
- Data management status reports
- Data extraction and transfer
Biostatistics and Programming Services
- Biostatistics consultation
- Clinical development plan and strategies
- Protocol/trial design
- Statistical analysis plans (SAPs)
- Review of approved product FDA Statistics reviews
- Rapid regulatory response
- Programming for tables, figures and listings
- CSR/ISS/ISE production
- Annual reports/DSURs
- Generation of analysis datasets
- CDISC Submission standards, including legacy data conversion
- Observational studies/RWE
- Data mining, meta-analyses
- Data monitoring committees, evaluation committees and interim analyses outputs
Why Choose Us
Top-notch Quality
We deliver high-quality services that adhere to industry standards and best practices, ensuring accuracy and reliability in every aspect of data management, biostatistics, and programming.
Timeliness
Our team is committed to meeting deadlines and milestones to ensure your project stays on schedule.
High Efficiency
Our streamlined processes and efficient workflows maximize productivity and minimize turnaround times, allowing you to focus on advancing your clinical development goals.
Regulatory Compliance
We understand the importance of adhering to the regulatory requirements of the pharmaceutical industry. Our team is well-versed in regulatory guidelines and standards, ensuring that your clinical data meets the necessary regulatory scrutiny for successful submissions.
High Client Satisfaction
Your satisfaction is our priority. We value open communication, responsiveness and collaboration to ensure your expectations are met and exceeded.