Department of Clinical Research and Clinical Trial

Greetings from The Clinical Research and Clinical Trial Unit of Netaji Subhash Chandra Bose Cancer Hospital!!!

Netaji Subhash Chandra Bose Cancer Hospital (NSCBCH), Kolkata is a tertiary care cancer hospital. Established in 2004 as a cancer hospital in Park Street, the total bed capacity of the hospital today exceeds 100. Netaji Subhas Chandra Bose Cancer Hospital is NABH accredited with a Registered Ethics Committee. We will soon have NABL accredited Labs also

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 performed under strict guidance of them. Other details of their departments can be obtained by visiting our website, www.nscri.in

Our Clinical Research and Clinical Trial started its journey from 2004 under the able leadership of our beloved Medical Director late Dr Ashis Mukhopadhyay. Since 2007 the department is headed by Dr. Chinmoy K Bose MD, PhD, DSc fellow 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 NSCBCH 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) thereof.

2. Patient counselling and both Audio/Video consenting

3. Separate trial patient treatment area.

4. ICCU/CCU/ITU (15 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. Calibrated 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 with 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-19, Effective from May 2019 and Valid up to May 2024)

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.

26. In house Blood bank facility.

Bone scan, X-Ray, CECT

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.

We aspire to partner with your madrigal and multinational organizations as "Clinical Trial Site" for providing you designated clinical research services. Our research unit will be totally committed to delivering high-quality data through ethical conduct of research. It would be our pleasure to welcome al at our site to see our set-up and check the feasibility of sponsor's upcoming research studies. Kindly let us know a convenient date and time for your proposed visit.

Our research team can be contacted on 9830114880 for assistance or information at any time.

We look forward to a healthy business relationship which not only will raise the bar for Clinical Research in India but also will help humanity at large.

Contrary to popular belief, Lorem Ipsum is not simply random text. It has roots in a piece of classical Latin literature from 45 BC, making it over 2000 years old. Richard McClintock, a Latin professor at Hampden-Sydney College in Virginia, looked up one of the more obscure Latin words, consectetur, from a Lorem Ipsum passage, and going through the cites of the word in classical literature, discovered the undoubtable source. Lorem Ipsum comes from sections 1.10.32 and 1.10.33 of "de Finibus Bonorum et Malorum" (The Extremes of Good and Evil) by Cicero, written in 45 BC. This book is a treatise on the theory of ethics, very popular during the Renaissance. The first line of Lorem Ipsum, "Lorem ipsum dolor sit amet..", comes from a line in section 1.10.32.