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Statistical Analysis

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

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Biostatistics

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  • 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

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SDTM

Create SDTM from EDC, Lab, Coding, etc. Tracking Data Issue;

Perform SDTM PC21 validation;

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ADaM

Create ADaM from SDTM for safety and efficacy analysis;

Perform ADaM PC21 validation;

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TFLs

Create tables, figures, and listings

of clinical study report for regulator and sponsor‘s review;

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Define

Create SDTM and/or ADaM define.xml

for FDA/PMDA/EMA/SFDA. E-submission 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

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Quality system

Service advantages

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Operation in both China&US.

24-7 Full time services.

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Internationalized professional team with excellent qualification.

Deep professional skills and industry knowledge.

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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.

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Continual improvement in Quality Management System.

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Xihua Headquarters

Address:Building 5, 6 and 7, Lane 118, Furonghua Road, Pudong New Area, Shanghai

Learn more>

Business Consulting

China

Tel:+86-21-5808 6608

Email:BD@xihuasci.com

Overseas

Tel:+01-609-921-7115 (US)

Fax:   +01-609-921-7116 (US)

Other Consultations

China

Email:IR@xihuasci.com

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