Loudon Far East - Biometrics (LFE Biometrics) in China has an experienced team with staff members with majors in biostatistics, mathematical statistics, computer science, medical science, who have been involved in clinical data management and statistical analysis for international clinical trials.

LFE Biometrics is one of the very few CRO organizations in China that provides on the spot professional clinical data management which meets the requirements of US FDA 21 CFR Part 11(Electronic Records & Signatures) and statistical analysis in line with ICH-GCP. It has established a robust quality control system, which is audited by major international CROs.

Computer system for data management

Computer System in Shanghai

Hardware: clients/sever Network architecture

Software: ClinStReport CDM System, The SAS System,

ClinStReport SAS macros

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ClinStReport CDM System

ClinStReport CDM system is a Oracle/Microsoft SQL Server based clinical data management system, which meets the requirements of US FDA 21 CFR Part 11(Electronic Records & Signatures), includes Modules on DATABASE DESIGN, DOUBLE DATA ENTRY, MEDICAL CODING, EDIT CHECK, DATA CLEANING, DATA LOCK/UNLOCK and AUDIT TRIALS.

ClinStReport CDM System is validated according to Guidance For Industry 21 CFR Part 11; Electronic Records; Signatures Validation

Data management services

Design case report forms (CRF)

Develop data management plan(DMP), data entry instructions

(DEI) and data validation manual(DVM)

Design and setup study database which meets the 

requirements of US FDA 21 CFR Part 11(Electronic Records &

Signatures) with audit trails

Develop data check specifications (Edit Check)

Perform double data entry and data verification

Develop and resolve data queries

Track CRF/Query 

Create CDISC and analysis SAS datasets

Transfer/exchange study data with clients

Ensure study data secure (Access control, backup, disaster

recovery)

Perform medical coding: MedDRA for AEs/disease/surgery,

WHO DD for medications

Conduct SAE reconciliations

Quality Control: Internal QC: 0.0% error rate for critical data;

0.1% error rate for non-critical data

Clean and lock study data