Services
It is our commitment that you can depend on us for advising "solution-based approach" on your academic, pilot 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