Aileen Clinical Research Services

AILEEN registered in August 2016 as a Limited Liability Partnership company based out of Hyderabad, India can help you transform your innovative pharmaceutical, biotechnology, cosmetic and medical device technology, or product into a commercial reality. AILEEN can coordinate phase 1 to 4 and post-licensure clinical trials/ investigations/ studies, quickly and efficiently in healthy volunteers and patient populations across India. It is our commitment that you can depend on us for coordinating your clinical phase 1 to 4 trials/ investigations, clinical BE studies and investigator-driven academic studies in India as per your study protocol, international and national regulations and guidelines Our services include 1. Regulatory Affairs Submission of Regulatory Dossier for Application of Conduct of Clinical Trial/ investigation, and Registration & Import of Medical Device (CDSCO) 2. Medical/ Scientific Writing (study protocol to manuscripts) Writing Clinical Study Protocol/ Investigation Plan Designing Case Report Form, Participant Information Sheet, Informed Consent Form and other study related documents Review of Sponsor’s Study Protocol/ Investigation Plan for compliance with Regulatory and appropriate Guidelines 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 Interim 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