HERINGS는 임상연구의 모든 분야에 있어서 신뢰할 수 있는 최적의 서비스를 제공합니다.

BIOSTATISTICS

MAIN SERVICES AND DETAILS

CONSULTING

  • Clinical Trial Design
  • Statistical Methodology Design
  • Sample Size Calculation
  • Power Calculation
  • Randomization
  • Feasibility Assessment
  • Literature/Reference Search and Review
  • Protocol Translation

STATISTICAL ANALYSIS

  • Statistical Analysis Plan (Programming & Validation)
  • Meta Analysis
  • Exploratory Analysis
  • Interim/Final Statistical Analysis
  • Development of Statistical Analysis Plans (SAPs)/ Statistical Analysis Report (SAR)
  • DSMB report
  • Safety Analysis

BIOMARKERS VALIDATION

  • In Vitro Diagnostic Multivariate Index Assays (IVDMIA): Model Development/Validation
  • Companion Diagnostics – Performance Evaluation
  • Potency Evaluation

MEDICAL WRITING

  • Protocol/Informed Consent Form Development
  • Case Report Form (CRF) Development
  • Investigator Brochures
  • Statistical Analysis Report and appendices
  • Clinical Study Report/ Manuscript Writing

DATA MANAGEMENT

MAIN SERVICES AND DETAILS

  • Database Structure Development(eCRF Development..)
  • Randomization Support
  • Data Migration
  • Data Management Plan (DMP) Development
  • Data Validation Plan (DVP) Development
  • Create eCRF Entry Guideline
  • Query Programming
  • Query Generation & Medical Data Review
  • DM Report
  • Medical Coding
  • CRF Tracking and Double Data Entry (paper only)
  • Data Export to STATA
  • Data Validation Report (DVR)
  • Data Transfer & DB Locking
  • Data Back-Up & Archiving

WEB BASED SOLUTION

  • Adequate for Multicenter clinical trials
  • Adaptable workflows
  • Rich feature sets
  • Extensive customization options

  • Powerful Data Report System
  • Ease of Data Analysis
  • Web-based real time operation

  • Antivirus server installation
  • Regular DB Backup
  • Intrusion Prevention System
  • Removing web service operations
  • 21 CFR Part 11.10 compliance

MAIN FUNCTION

PATIENT MANAGEMENT

  • Patient enrollment / registration
  • Patient’s visit schedule management
  • Casuistic records and abnormalities record and tracking

PROTOCOL MANAGEMENT

  • Web-based assignment development
  • Schedule creation and control according to assignment
  • Assignment progress by participated organization

DATA MANAGEMENT

  • Creation and management of electronic casuistic records
  • Data e-query

REPORT

  • Provision of various report form
  • Creation of customer based report

CLINICAL OPERATION

MAIN SERVICES AND DETAILS

MONITORING

  • Site Staff Training
  • Pre-Study Site Visit
  • Site Contract and Management
  • Interim Monitoring Visit
  • Query Resolution
  • SAE Affairs

REGULATORY AFFAIRS

  • IRB Process
  • IRB Submission
  • Pre-IND Meeting
  • IND/IDE Submission
  • NDA/MDA Submission

EDUCATION

BASIC STATISTICAL METHODOLOGY

  • Definitions, Vocabulary
  • Descriptive Statistics
  • Correlation / Linear Regression
  • ANOVA / MANOVA Multiple Comparisons
  • Non-parametric Statistics
  • Categorial Data Analysis
  • Logistic Regressions
  • ROC Analysis
  • Survival Analysis
  • Meta Analysis
  • Statistical Considerations for Clinical Trials

CLINICAL TRIAL DESIGNS

  • End point Selection
  • Randomization
  • Biomarker Based Designs
  • Platform Trial Designs
  • Sample Size / Power Calculations
  • Adaptive Design
  • Clinical Trial Design for Companion Diagnostics
  • Statistical Analysis Plan
  • Safety Analysis
  • Interim Analysis
  • Data Safety Monitoring Board (DSMB)

DATA MANAGEMENT

  • Data Management Summary
  • Data Management Plan
  • Protocol Review & eCRF Design
  • Data Management Database Development
  • Database Validation Specification
  • Data Management Global Trend & CDISC
  • Clinical Trial For EDC

SERVICES PROCESS

HERINGS의 서비스는 아래와 같이 진행 됩니다.
추가적으로 궁금하신 사항은 아래의 연락처와 CONTACT US로 문의 주십시오.

STEP1

서비스문의

STEP2

연구지원 가능 여부 및 견적 확인

STEP3

계약 진행

STEP4

서비스 시작

NEED OUR SERVICE?

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Main Office: 서울시 강남구 논현로 726, 401호

Room 401, 726 Nonhyeon-ro, Gangnam-gu, Seoul, 06051, Korea
Tel: 02) 6949-3516 / Fax: 02) 6949-3517
Email: HERINGS@heringsglobal.com

CONTACT US