Global Biometrics Excellence: Powering Clinical Trial Success

Founded in 2003, we are an international biometrics service provider with strategic offices across the United States and Asia, serving the needs of pharmaceutical and biotech companies worldwide

International Expertise & Leadership

Our biometrics teams bring together the best talent from across the globe:

●200+ data statistics professionals across domestic and international locations

●500+ clients served across pharmaceutical, biotech, and medical device sectors

●2,200+ successful projects completed, supporting numerous breakthrough therapies

●US leadership team with 30+ years of industry experience, including veterans from Novartis, Celgene, AstraZeneca, and other leading pharmaceutical companies

●Core team averaging 17+ years of experience in biometrics and clinical research

●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

●Therapeutic expertise spanning oncology, gene therapy, hematology, ophthalmology, rare disease, metabolism, and many other areas

Expert Resources & Strategic Partnerships

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

●Former FDA statistical review experts providing guidance and support

●CDISC Gold Member with 12 years of experience in CDISC submissions to FDA, EMA, and PMDA

●Active participant in CDISC guideline creation

●Starting over 150 projects annually

●Industry leader in implementing centralized monitoring and inspection

Proven Track Record

●Assisted in the launch of over 160 products

●Domestic leader in implementing centralized monitoring and inspection

●High customer satisfaction, with repeat orders exceeding 67%

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

Strategic FDA & Regulatory Experience

Our US biometrics leadership team maintains frequent interactions with regulatory authorities and possesses rich FDA submission experience. We provide end-to-end support from strategic planning and protocol design through submission, leveraging our deep understanding of regulatory requirements and statistical methodologies.

Technologically Advanced Systems

●5+ invention patents and 26 software copyrights

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

●Certified in multiple EDC systems including 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

Quality & Assurance

Our commitment to quality is reflected in:

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

●International SOPs & Templates: Developed from expertise with top 5 global pharma companies

●Robust Process Systems: Refined through 20+ years of domestic and international audits, inspections, and reviews

●High Customer Satisfaction: 67%+ repeat business rate

●Quarterly Satisfaction Tracking: Ensuring prompt resolution of any issues

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

●Strong financial backing to drive future growth

Over a decade-long partnership with a growing biotech company, our biometrics team provided strategic and operational support across their entire development portfolio. This collaboration:

●Saved the company over $30 million in development costs

●Supported 3 successful FDA approvals

●Enabled efficient scaling of their biometrics capabilities as the company grew

●Provided flexible resourcing during periods of peak activity

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 FDA, NMPA, PMDA or EMA 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