• Case Report Form Design
• Interface Set-up
• On-line edit checks set up
• Data Review & Query Management
• External Data & SAE Reconciliation
• Local lab data Handling
• Medical Coding
• Data Quality Control

• Data Management Plan
• Data Validation Plan
• Data Transfer Agreement(s)
• eCRF Completion Guidelines
• Medical Coding Plan
• Data Progress/Status Reports
• (Blind) Data Review Meeting
• Data Management Report

• Statistical design and consultation
• Sample Size Estimation
• Clinical Pharmacology（PK/PD analysis, BE, QT/QTc analysis, etc.）
• Statistical Analysis Plan (SAP) Development
• Production of Tables, Figures and Listings (TFLs) and Shells
• (Blind) Data Review

• Randomization
• Data Monitoring Committees and Interim Analysis Support
• Rapid Regulatory Response
• CSR Stats. Support
• IND Stats. Support
• NDA Stats. Support
• Publication Stats. Support

• Statistical Analysis Report (SAR)

• Clinical study planning
• Pharmacometrics design andconsultation

• Compound screening
• Preclinical pharmacodynamic prediction
• Formulation determination

• Safety
• E-R analysis
• PopPK
• PBPK 
• PK/PD

• BA/BE

• DDI

• C-QT analysis

• Bridging study

• Ethnic difference analysis
• Dosing regimen optimization/ individualization
• Medication for special populations
• Instruction manual information
• Regulatory

Core Services Pre-marketing

• PV Operation

· Safety Management Plan, Risk Control Plan

· SAE Receiving and Processing (Case Entry,      Narratives, Review & QC, Query, Follow-up,

  Unblinding)

· SAE/SUSAR Submission

· Carry out/Assist in SAE Reconciliation

· PSUR/Accelerated Report Preparation

· PV Database Maintenance

· Monthly Analysis Report

• PV Science:

· Medical Review and Assessment of SAE

  (Expected, Related, etc.)

· DSUR Preparation

• PV Compliance:

· Set-up PV System

· Professional Training

· Assist in PV Audit

· Regulatory and Guidelines Updates Tracking

Core Services Post-marketing

• PV Operation

· ICSR Case Entry, Narratives, Coding,

  Assessment, Submission

· Handing of Batch Cases Fed Back by Regulatory 

  System (Entry, Submission)

· Batch Handing of Overseas Cases (Translation & Reporting)

· E2B Submission

· PV Database Maintenance

· Literature Retrieval /Social Media

· AE Monitoring

• PV Science:

· Medical Review and Assessment of ICSR

  (Expected, Related, etc.)

· DSUR, PSUR Preparation; Safety content

  required for re-application; PV master documents

• PV Compliance:

· Set-up PV System      · Professional Training

· Assist in PV Audit

· Regulatory and Guidelines Updates Tracking

Operation in both China&US.

24-7 Full time services.

Internationalized professional team with excellent qualification.

Deep professional skills and industry knowledge.

Early intervention, Full participation.

Comprehensive project design and Effective planning

Risk reduction, Cost-effective and Create added value for clients.

Mature standard operation procedures.

Continual improvement in Quality Management System.