Services
It is our commitment that you can depend on us for advising "solution-based approach" and coordinating your academic, pilot, or pivotal clinical investigations/ performance evaluation for medical devices and in vitro diagnostic kits, and clinical phase 1 to 4 trials in India as per your clinical investigation plan/ clinical study protocol, regulations and guidelines. AILEEN can coordinate phase 2 to 4 and post-licensure clinical trials with its partner, APCRA (www.apcra.com) in Hong Kong, Taiwan, and Australia.
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 paper 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