• A Contract Research Oroanization 1CRO) dedicated to deliver auantitative solutions to pharmaceutica companies
• Established in Dover,Delaware in 2017
• Employees located in New Jersey, USA and Beijing, China
• We help clients to deliver results by offering flexible operating models based on client needs：

    ­­— Project-based model: provides deliverables based on RFP
    ­­— FTE-based model: provides dedicated project team for a period of time at a fixed rate per FTE unit
    ­­— Strategic consultation model: provides consultation to product development strategy and clinical trial design

• CRF design
Data Management Plan
Data Review,Cleaning and Reconciliation
Data Flow and Trending Review
• Medical dictionary coding
SAE reconciliation
Technical and system support
Data capturing system design and implementation

• Go/No Go Decision
• Study Design and Protocol Development
• Statistical Analysis Plan and Report(SAP and SAR)
• CFDA/USFDA/EMA，etc.submission
• PK/PD data analysis and modeling
• Exploratory analysis
• Real world data
• IDMC independent statistician

• Derived dataset production and validation
• TLFs production and validation
• CDISC implementation ( SDTM, ADaM, Define.xml, aCRF)
• e-Submission and eCRF annotation
• Migration/conversion program and data validation
• Data warehouse design

• Clinical development plan and global regulatory strategy
• Protocol design
• Access to scientific advisory board
• Quality oversight
• Vendor assessment and due diligence
• SOP setup