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AILEEN

Clinical Research Services

Services

It is our commitment that you can depend on us for advising "solution-based approach" on your academicpilot or pivotal clinical development pathway for medical devices, pharmaceutical or biological. In Hong Kong, Taiwan, and Australia, AILEEN can coordinate phase 2 to 4 and post-licensure clinical trials with its partner, APCRA (www.apcra.com).

 

1. Regulatory Affairs

  • Online submission of Regulatory Dossier for Test License, Application for Conduct of Clinical Trial/ Investigation/ Clinical Performance, Registration and Import of Medical Device/ Investigational Product as per CDSCO requirements.

2. Medical/ Scientific Writing

  • ​​Writing/ Reviewing Clinical Investigation Plan/ Clinical Study Protocol, Investigator Brochure, Participant Information Sheet, Informed Consent Form and other study related documents
  • Designing Case Report Form
  • Write Clinical Evaluation/ Study Report
  • Write Manuscripts and submit to Scientific Journals

3. Project Management

  • ​​As per study guidelines, and within budget and timelines

4. Clinical Monitoring

  • Site/Investigator Feasibility/ Assessment
  • Study/Site Initiation
  • Periodic Monitoring 
  • Study/ Site Close-out

5. Medical Monitoring and Safety Reporting

6. Training

7. GCP Audit

 

Thru our trusted partners, we will provide thru an oversight on:

  1. Data Management
  2. Biostatistics