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Statistical Analysis

STATISTICAL ANALYSIS

Service introduction

Data Management

  • Case Report Form (CRF) Design
  • (e)CRF Design Specification
  • Database Design
  • Edit Check Programming & Testing
  • Draft Data Management Plan (DMP)
  • Data Entry and Lab Data Management 
  • Provide Data Management Report 

  • Medical Coding with MedDRA and WHODrug
  • Quality Control
  • External Data Management
  • SAE Reconciliation 
  • Protocol Deviation Handing and Reconciliation 
  • Provide DM Status Progress Report
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Statistical Analysis

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  • Statistical Consultation and Study Design
  • Sample Size Estimation
  • Statistical Analysis Plan (SAP)
  • Tablets, Figures and Listings(TFLs) & Shells
  • Blind Data Review
  • Statistical Analysis Report
  • Randomization Management Plan
  • Data Monitoring Committee (DMC) Support
  • Interim Analysis Support
  • Clinical Study Report (CSRs) Support
  • Investigational New Drug (IND) Support
  • New Drug Application (NDA) Support
  • Statistical Support for Publication

Statistical Programing

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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

  • Non-compartment Analysis (NCA)
  • PK/PD statistical analysis (dose escalation, BA/BE, ADA & Nab, DDI, food effects, special population studies, etc.)
  • PK/PD exploratory research(NLME)
  • BE analysis (including drugs with high variation, narrow treatment window, long half-life, etc.)
  • Clinical trial design and consultation regarding with PK
  • Sample size/confidence calculation
  • PK Standardization (CDISC)
  • Compartment Analysis

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

FIH
Phase II RP2D
Phase III risk benefit prediction

Software

Special Population Drug Therapy
Special Population
DDI
PPI
VBE

PK/PD/PBPK modeling

E-R Analysis
PopPK
PBPK
PK/PD

Other Applications

Ethnic Difference Analysis
Dose Titration Post-marketing
Pediatric Dose Extrapolation

Related Content Instruction of Drugs

Pharmacovigilance

  •  Handling of individual safety reports (receiving, preliminary classification, input, quality control, medical review) 
  • Follow-up/challenge management of individual safety reports  
  • Scheme and CRF review (Security section)
  • Safety Management Plan (SMP) 
  • DSUR/PSUR/ annual safety analysis report writing and review
  • Medical event narrative writing
  • E2B electronic submission of case reports is supported
  • Use and maintain PV database 
  • Safety data consistency verification suppor
  • Writing of pharmacovigilance service commission agreement
  • GVP system construction consulting support
  • Other PV service support (such as literature retrieval, feedback data processing, etc.)
  • SUSAR
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Quality system

Service advantages

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America's senior statistician led the way with a deep understanding of disease and medicine.

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Early involvement in project design and effective planning.

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Operation entity both in U.S. & China, deep and broad expertise with 20+ years’ experience & accumulation. (TCM) has the ability to conduct data management and statistical analysis for drug clinical trials, the numerous practices and rich application experience to support the FDA application.

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Abide by the group's core service concept and commitment of " Quality &Punctuality ", Quick response to emergency projects.

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It has undertaken more than 100 CDISC projects at home and abroad, and has assisted or represented clients in FDA/EMA/CDE review meetings, communication plan revision, efficacy endpoint change, statistical methods, etc., successfully supporting clients to pass FDA/CDE and other regulatory authorities verification.

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

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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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