Clinical Operations: Highlights
- Scope: Perform Phase II, III & IV studies. Support to Local Registration studies as & when needed
- Data: generated from Indian sites is at par with the data generated across the world as evidenced by successful US FDA & DCGI Inspections
- US FDA Inspections: occurred at 06 sites. There was no critical finding. For 04 sites there were No Actions Required & at 02 sites there were Voluntary Action Indicated.
Initiatives for Improving the Quality at Sites
- BI India conducts all studies using its own Clinical Operations Team
- Several team members are members of the Indian Society of Clinical Research (ISCR) which is committed to improving the standards of Clinical Research by working with various stakeholders such as DCGI, Ethics Committees of Hospitals, Principal Investigators and Media as well.
- Several training initiatives have been undertaken to improve the skills of the clinical site personnel. Videos on the below mentioned important topics are developed for the benefits of site personnel:
- Video on Audio Visual Recording of the Informed Consent Process
- ALCOA Principles (Good Documentation Practices)
- Protection of Patient Confidentiality -https://youtu.be/a6lbYziw3fs?list=PLu_Z0IlqEaf-xjuKZoo990HTPhZyQD53I
- How to write SOPs - https://youtu.be/4Wq9Smbk9Fw?list=PLu_Z0IlqEaf-xjuKZoo990HTPhZyQD53I
- Corrective Action and Preventive Action - https://youtu.be/VwlELbog1hU?list=PLu_Z0IlqEaf-xjuKZoo990HTPhZyQD53I
Clinical Trials Registry in India (CTRI) : is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in)
All clinical trials being conducted by Boehringer Ingelheim India can be found at this site.