Ahana Hospitals LLP is a Neuropsychiatric Hospital with an integrated clinical research department specializing in conducting and enabling novel and systemized research in the field of psychiatry aimed at driving healthcare in a positive direction. The clinical research unit endeavours to undertake and promote excellence in clinical research and to foster and support patient care and treatment. In line with Ahana Hospitals’ high ethical standards, the clinical trials are conducted in compliance with regulatory requirements that ensure and protect the subjects’ safety, well-being, and rights.
Our site has conducted more than 40 trials in phases II, III, IV, and BA-BE—global and multi-centric trials—for over a decade now. The US FDA has inspected the site. We’ve done clinical trials on the following indications: Major depressive disorder, Schizophrenia, Premature ejaculation, Bipolar disorder, Adolescent Schizophrenia, and Depression with Anxiety disorder.
All the team members have been trained according to ICH-GCP guidelines, ICMR guidelines, and NDCT rules 2019.
US-FDA Audits
Our centre has been audited by the US-FDA twice in Apr 2015 & Jul.2022 with no Observations (Form 483)
| Team Members | Team Member Count |
|---|---|
| Principal Investigators | 3 |
| Sub-Investigators | 4 |
| Raters | 5 |
| Phlebotomist | 3 |
| Study Co-ordinators | 4 |
| Nurses | 3 |
| Pharmacist | 2 |
Clinical Research Facilities
The Site Has Well-Equipped Infrastructure Facilities to Conduct Clinical Research
The Facilities Include:
- -80 C and -20 C Deep Freezer.
- Refrigerators and Access Controlled Room for drug storage.
- Thermohygrometer Temperature Recorder.
- 24 x 7 Power Backup.
- High-speed Centrifuge.
- ECG Machine.
- EEG.
- Document Storage Area.
- Customized SOP and Protocols.
- High-Speed Internet Connections.
- Cooling Centrifuge.
- Archival room.
Ethical Oversight & Institutional Ethics Committee
All the instruments are regularly calibrated.
The ethical aspects of the trials are collectively monitored and reviewed by our Central Drugs Standard Control Organization (CDSCO) registered Institutional Ethics Committee. The IEC is responsible for scientific, ethical, and regulatory oversight of research conducted at Ahana Hospitals and serves to protect the rights and welfare of human subjects. In Addition to it, the IEC reviews and approves academic research projects conducted by the Ahana hospitals.
