Statistical Analysis_Shanghai Xihua Scientific Co.,Ltd.

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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

Statistical Analysis

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；

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；

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

Quality system

NMPA

ICH

FDA

CDISC

GDPR

GCP

Service advantages

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

Early involvement in project design and effective planning.

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.

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.