AILEEN

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 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