Greetings from The Clinical Research and Clinical Trial Unit of Netaji Subhash Chandra Bose Cancer Hospital!!!
Netaji Subhas Chandra Bose Cancer Hospital has an integrated Clinical Research and Clinical Trial Unit at our hospital and we would like to expand our Clinical Research activities in days to come. We have an OPD of around 3500 patients per month which is inclusive of indications like medical oncology, surgical/gynaecological oncology and radiation oncology. All the faculty consultants of the hospital closely work together with this unit. They become Principal Investigators/Co- investigators of the research and trial. We perform the trials under strict guidance of the investigators.
Our Clinical Research and Clinical Trial started its journey from 2004 under the able leadership of our beloved Medical Director late Dr Ashis Mukhopadhyay. The department is headed by Dr. Chinmoy K Bose MD, PhD, DSc who is also gynaecological & Clinical Oncologist. The staffs at the Clinical Research and Clinical Trial Unit include Projects-in-charge, Sr. CRCS, CRCs, Research Nurses and Lab technicians who are well trained in GCP and other aspects of Clinical Trials. Doctors and all staffs of clinical trial division of NCRI are well trained and certified in Good Clinical Practice.
As a Clinical Research and Clinical Trial Unit, we have established the following facilities:
1. We do all clinical trials and researches according to the recent amended (2019) Drugs and
Cosmetic Act 1940 and rules (1945) there-of.
2. Patient counselling and both Audio/Video consenting
3. Separate trial patient treatment area.
4. ICCU/CCU (08 Beds)
5. Electronic Patient Data Records System
6. Facility for conducting PK Study at the site.
7. Drugs storage facilities.
8. Laminar flow for IP/Chemotherapy mixing area
9. Refrigeration facility (Cold to very cold up to -80°c)
10. Calibration of all medical equipments (BP apparatus, Weighing machine, Height machine, Thermometer, Temperature data logger).
11. Power Backup (24x7).
12. Centrifuge (Normal & Cooling)
13. Calibrated diagnostic instruments, required for Clinical Research and Clinical Trial Unit
14. Study document storage area under lock and key
15. Study Archival facility
16. ISD connection and phone lines.
17. Desktop, Laptop computers
18. Internet Connection
19. Customized Site SOP & Protocols. Also we follow directives of our institutional ethics committee as per their SOP
20. Fire & Pest protected.
21. Ethics committee registered with CDSCO (Reg. No. ECR/286/Inst /WB/2013/RR-24, Effective from May 2024 and Valid up to May 2029)
22. Investigators' meeting room.
23. Sponsor/ CRO monitoring room.
24. In house Clinical laboratory facility with EQAS accredited.
25. In house Radiological laboratory (ECG, 2D-ECHO/ MUGA/GUMMA, (Di-com format), PET-CT facility with AMC, Bone scan, X-Ray, CECT
26. In house Blood bank facility.
27. Dedicated drug storage facility with 24hrs electric supply and temperature monitoring with data logger.
At our Clinical Research and Clinical Trial Unit, we have completed many critical cancer studies of Pilot study, BA/BE study, Phase-I, II, III, IV studies with several indications like lung, breast, prostate, Colon, Head & Neck, Ovary etc among solid tumours and lymphoma, chronic and acute leukemias sponsored by National & Multinational Companies (List of pharmaceuticals name are Novartis, GSK, Sanofi Aventis, Bristol-Myers, Pfizer, Kariyopharm therapeutic, Nicolas Piramal, J&J, Eli-Lilly, Astra Zeneca, Biocad, Hetero, Zidus Cadila, Lupin, DRL etc).
Thus we have work experience of global & national clinical oncology study. We have faced regulatory audit and inspections by international and national authorities like FDA, CDSCO, DCG (1), Sponsor & Third party also. Since inception of our department we have completed approximately 65 trials (Global & National) till date.
We firmly believe that quality begins at the research site as also in the mind of investigator and assurance of uncompromising quality is what we all are aspiring for. Our research unit will be totally committed to delivering high-quality data through ethical conduct of research.