Clinical Development

Data Management and Statistical Analysis

Flexible and accurate biometrics solutions from study start-up to close-out. Delivery with high quality and data Integrity.

Global, Reliable and Flexible

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.
1,100+

Biometrics experts

5,700+

Completed projects

3,000+

CDISC projects

97

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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