Data Management and Statistical Analysis

With 800+ global experts in China, USA, Korea and India, well-established Standard Operation Procedures, and in-depth knowledge of industry standards and best practices, we are dedicated to providing high-quality, timely and cost-effective Data Management, Biostatistics and Statistical Programming services to support clinical development and regulatory submissions.

Local teams in APAC and US for global customer reach
Demonstrated proficiency in Data Management, Biostatistics, and Statistical Programming.
Profound knowledge across therapeutic domains, including Oncology, Immunology, Endocrinology, Neurology, and Infectious Diseases.
A strong team of over 100 employees skilled in using Medidata Rave, Clinflash EDC, and Oracle Clinical.

800+

Biometrics experts

4,700+

Completed projects

1,300+

CDISC projects

NDA/BLA Submissions to FDA with new indications

Data Management
Our excellent data management experts work on comprehensive solutions to identify insights of your research and ensure data is well organized, secured and compliant
- Dictionary management after coding
- Risk Based Quality Management
- Close collaboration with clinical and biostatistics
- Data capture and management using EDC systems
- CRF/eCRF design
- Database design, development, and maintenance
- Data validation specifications and edit check programming & testing
- SAE reconciliation
- External data handling and reconciliation
- Data management status reports
- Data extraction and transfer
Biostatistics
Our comprehensive clinical biostatistics services can be tailored to meet your diverse project needs.
- Expertise in Estimands and ICH E9 R1
- Conform to FDA and EMA current requirements
- Review of approved product FDA Statistics reviews
- Analysis of prior trials and public databases to determine placebo response
- Design your trial and SAP with deep therapeutic expertise
- Optimize statistical aspects of trial design for greatest likelihood of success
- Exploratory analysis specification
- Rapid regulatory response
Statistical Programming
Our programming team provides full-service support through all phases of clinical development to optimize outcomes and reduce risk.
- Development of submission-ready datasets and supporting documents in CDISC format: Annotated CRF, SDTM, ADaM, Define.xml and Reviewer’s Guide
- Generation of Analysis Datasets
- Production of Tables, Figures and Listings (TFLs)
- Data Monitoring Committees, Evaluation Committees and interim analyses outputs
- Generation of pooled datasets and TFLs for Integrated summary of efficacy and safety (ISE/ISS)
- Rapid regulatory response outputs
- Publication and ad hoc analysis outputs
- Exploratory data analysis outputs
Data Security and Privacy
- Data access controlled with Microsoft Active Directory
- Well-established SOPs/Polices to protect data: Policy-01 Information Protection Policy, Policy-05 Protection of Personal Data, SOP-G-05 Protection of Subject Privacy, SOP-G-13 Personal Data Breach Response
- Data Processing Addendum in accordance with GDPR to adduce adequate safeguards with respect to the protection of privacy

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