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Management Profile
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Welcome to our company

CRO Service ¨C Contract Research Organization

ATHENA keeps comprehensive and updated Standard Operating Procedures in compliance with ICH-GCP and Chinese GCP. Thus ATHENA is always able to provide qualified services for customers' needs. ATHENA has begun to deliver various projects for multinational pharmaceutical companies since 2007. ATHENA¡¯s professional team and the long term relationship with many Key Clinical centers enable us to ensure valuable services for customers and to obtain qualified clinical data.

The services are as following:
1) Clinical Study Operation & Management
     - Site feasibility study
     - Study document preparation (protocol, CRF, IC)
     - PI contact
     - Investigators¡¯ meeting preparation and minutes writing
     - Monitoring
     - QA
     - Data management and Statistical Analysis
     - Study report writing
     - GCP-training

ATHENA has experience in the following areas:
     - Phase ¢ó Trials
        International protocol and other related documents/GCP guidelines
     - Registration trial
        Multi-center, Double blind, double dummy, active controlled   design
      - Phase IV study
        Multi-center, open label, non- comparative design
      - Epidemiological study
        Multi-national epidemiological survey
      - Bio-equivalent study
      - Health-economic study

2) Biostatistics
Our team of DM & SA can ensure that your project completion is timely and accurate under the regulation requirements.

  • Data Management
    Set up database
    - Review CRF
    - Double Entry of data
    - Check of Data
    - Discrepancy generation and data correction
    - Blind review and lock of data
  • Statistical Analysis
    - Statistician involved in protocol development
    - Generate randomization list and blinding of drug
    - Define statistical analysis report
    - Complete statistical analysis report
    - Review of final report by statistician

3) Regulatory Affairs
ATHENA is experienced in regulatory affairs. With a comprehensive understanding of IND and NDA procedures, ATHENA van assist in bringing your products on market as early as possible.

  • Feasibility Assessment
  • Translation, Documentation and Submission
  • QC Arrangement
  • Project Tracking

4) Medical ¨C Translation
Athena¡¯s full-time and part-time translators are all experts in the area¡¯s of medicine, biology, pharmacy. All data is handled under the confidentiality agreements as signed with our clients and we aim to provide timely, high quality translation at a reasonable price.

  • Professional translation for R&D dossier
  • Pharmaco-vigilance documents translation

Pharmaceutical R&D Consulting
Through our extensive network we may provide valuable services to meet your needs in the area of R&D Project Feasibility