Development History

● Founded in 2003, one of the pioneering data statistics teams in China, with over 20 years of development

● Began providing services to US clients in 2012, becoming one of the first offshore outsourcing teams in China

Team Experience

● 200+ data statistics professionals across domestic and international locations

● Core team: Average experience of 17+ years

● 31%+ employees with 5+ years of experience:

       - 2/3 internally trained

       - 1/3 from multinational companies → Ensuring stability & growth

● 30+ expert teams built over 7 years, maintaining industry-leading expertise

Expert Resources

● 20 years of close collaboration with top statistical experts from five leading domestic universities

● Former FDA statistical review experts providing support

Project Experience

● Serving over 450 domestic and international clients with 2200+projects

We have assisted in the launch of over 160 products, of which 4 have been approved by FDA/EMA

● CCDISC Gold Member, with 12 years of experience in CDISC submissions to FDA, EMA and PMDA, and an active participant in CDISC guideline creation

● Starting over 150 projects annually

● The domestic leader in implementing centralized monitoring and inspection

Quality & Assurance

● Comprehensive training system with a standardized course library of 1,000+ courses, enabling on-demand learning and technical support

● International SOPs & templates developed based on expertise from top 5 global pharma companies and CROs

● Robust process system, refined over 20 years of domestic and international audits, inspections, and reviews

● High customer satisfaction, with repeat orders exceeding 67%

● Quarterly customer satisfaction tracking, ensuring prompt resolution of communication and quality issues

● Dedicated key account managers and delivery teams, backed by client agreements for stable and reliable delivery

● Strong financial backing to drive future growth

Technologically Advanced Systems

● 5+ invention patents and 26 software copyrights

● Proprietary platforms for data management, randomization, modular programming, automated reporting, and project management

● First in China to introduce SAS OA version and establish a clustered Citrix server platform

● Certified in Medidata Rave, Coder, Builder, and RTSM systems, with an independent URL

● CRF & logic check template library built from 2,200+ projects

● Certified in 10+ leading domestic and international EDC systems

● Project data query & analysis platform developed from 2,200+ projects

● Knowledge management platform with 1,000+ case studies of lessons learned

Our Service Scope
Data Management
Data Management

● Data management consulting and training

● Case Report Form (CRF) design

● Database creation and testing

● Development of data management plans

● Development of data verification plans

● Logical verification programming and testing

● Manual verification

● Generation and resolution of data queries

● Medical coding

● Consistency checks for serious adverse events

● External data processing

● Data Management Master Document management

● Data Management progress reporting

● Blinded data review

● Database locking

● Data transmission

● Writing data management reports

Biostatistics
Biostatistics

● Provide statistical support for communication between sponsors and regulatory agencies

Clinical Trial Design and Consultation

● Adaptive design planning

● Statistical support for research plans

● Sample size calculation

● Development of randomization plans and blinding implementation

● Development of statistical analysis plans

● Creation of templates for statistical tables, charts, and lists

● Statistical analysis reports

● Statistical support for clinical research reports

● Registration and application statistics support

● Integrated Safety and Effectiveness Summary (ISS/ISE) planning

● PK/PD analysis

● IDMC organization and statistical support

● Centralized monitoring/CBM implementation

Programming
Programming

● Data conversion in compliance with CDISC standards: Case Report Form (CRF) annotations, SDTM, ADaM, Define files (PDF and XML versions), reviewer guidelines, Pinnacle tool verification, and conversion of historical data to CDISC standards, etc

● Generation and validation of analysis datasets that comply with the National Medical Products Administration standards, along with providing documentation for dataset descriptions

● Generation and validation of statistical analysis tables, charts, and lists (TFLs)

● Electronic submission, submission sorting, and quality control

● Integrated Safety and Effectiveness Summary (ISS/ISE) statistical programming

● Mid-term analysis and Data Monitoring Committee statistical programming
● Integrated Safety Database (ISDB) maintenance

● Statistical programming support for IND filings, article publications, and conference presentations

● Medical review and personalized graphical programming support