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统计分析（生命科学）
STATISTICAL ANALYSIS
Service introduction
Clinical Data Management
- 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
Biostatistics
- 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)
Statistical Programming
SDTM
Create SDTM from EDC, Lab, Coding, etc. Tracking Data Issue；
Perform SDTM PC21 validation；
ADaM
Create ADaM from SDTM for safety and efficacy analysis；
Perform ADaM PC21 validation；
TFLs
Create tables, figures, and listings
of clinical study report for regulator and sponsor‘s review；
Clinical Pharmacology
- Pharmacokinetics design and consultation
- Non-compartmental Analysis (NCA)
- Compartmental Analysis
- PK/PD Analysis (Dose escalation, BA/BE, DDI, Food effect, Special population)
- PK/PD Exploratory (NLME)
Quantitative Pharmacology
The company that provided both biopharmaceutical software customized development & services based on platform. Problem oriented, provide overall and feasible strategy for new drugs clinical study compliance with regulatory standards to facilitate new drugs research and development.
Apply advanced computer modeling and simulation techniques to guide clinical drug development, optimize or eliminate clinical trials, and accelerate new drugs development.
Clinical Strategy
· Clinical study planning
· Pharmacometrics design andconsultation
Drug discovery & Preclinical studies
· Compound screening
· Preclinical pharmacodynamic prediction
· Formulation determination
Clinical Research
· Safety · BA/BE
· E-R analysis · DDI
· PopPK · C-QT analysis
· PBPK · Bridging study
· PK/PD
Other Applications
· Ethnic difference analysis· Dosing regimen optimization/ individualization
· Medication for special populations
· Instruction manual information
· Regulatory
Pharmacovigilance
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
Service advantages
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.
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Mature standard operation procedures.
Continual improvement in Quality Management System.
Xihua Headquarters
Address：Building 5, 6 and 7, Lane 118, Furonghua Road, Pudong New Area, Shanghai
Learn more>Business Consulting
Overseas
Tel：+01-609-921-7115 (US)
Fax: +01-609-921-7116 (US)
Other Consultations
China
Email：IR@xihuasci.com
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