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Center Overview

Since 1989, B.M. Birla Heart Research Centre has been a leader in heart disease treatment in Eastern India. It is a super specialty hospital dedicated exclusively to the diagnosis, treatment and research related to cardio thoracic and vascular diseases. So far the centre has performed more than 16,000 cardiac surgeries and 66,000 catheterization procedures with a success rate of more than 99%. The entire spectrum of heart and vascular surgeries, right from neonates to elderly are carried out regularly. The center has become the most sought after heart hospital in Eastern India as not only patients from all over India seek treatment here, but patients from Bangladesh, Bhutan, Nepal, Mauritius, Hong Kong, Kenya and other neighboring countries also avail its facilities.

B. M. Birla Heart Research Centre is India's first NABH accredited hospital for patient safety & quality of care. It is the first hospital to be awarded ISO 9001, ISO 14001 and OHSAS 18001 for highest standards in healthcare, environmental protection and occupational safety respectively. Centre's pathology laboratory is accredited by College of American Pathologists (CAP) & National Accreditation Board for testing and calibration Laboratories (NABL), Ministry of Science and Technology, Govt. of India for international standard ISO/IEC 17025.

The centre is also recipient of various quality awards: Rajiv Gandhi National Quality Award Commendation Certificate; Jamnalal Bajaj Award for Professional Service; Award for Inspirational Workplace by Express Healthcare Excellence Award. Through the utilization of innovative technology and ground breaking therapies, our association has maintained a distinctive excellence in the field of heart disease detection and management.

 

Clinical Research Experience

B.M. Birla Heart Research Center is a research driven organization focusing on conducting clinical trials as a site. The investigators and research staffs of our centre are extensively into clinical trials on pharmaceutical products and devices. We work closely with study sponsors and CROs to understand all aspects of each study. Through our participation in phase III and phase IV clinical trials, our site has become recognized as a leading research centre in the field of cardiology. Our physician investigators have extensive research experience in such therapeutic areas as acute coronary syndrome, high cholesterol, metabolic syndrome, hypertension, heart failure, deep vein thrombosis, pulmonary embolism, atrial fibrillation, coronary and peripheral revascularization, sinus node dysfunction and sudden cardiac death. We have already worked with sponsors and CROs like Eli Lilly & Co., Abbott Vascular, Intas Pharmaceuticals, Daiichi Sankyo, The Medicines Company, Duke Clinical Research Institute, Quintiles Inc.

 

Facility Description

Clinical Research Department

We have separate Clinical Research Room equipped with dedicated STD/ISD fax machine, 24 hour Internet Connection, phone lines for making National and International calls, centrifuges. The department has separate storage area for investigational products with regular temperature monitoring and separate cupboards for archiving clinical trial related documents. The department also provides separate areas for accommodating clinical trial subjects and clinical study monitors. All the research staff members are trained in ICH-GCP and have sound knowledge about National and International Regulatory guidelines.

Clinical Research Department of BMBHRC offers the following site management services:

Pre-Trial

During the Trial

Post Trial

  • Feasibility study
  • Helping the Study start up group for PSSV Study.
  • Identify potential Investigators
  • Assist site start up specialist for IRB submission
  • IEC Submissions

            a. Proforma completion

            b. Check documents

            c. Preparation of Inv statement

            d. Packing documents

            e. Updated CVs of investigators

            f. Correspondence

            g. Communications with client

            h. Queries resolution

  • Document collection
  • Create source document template
  • Coordination and participation during Site Initiation
  • Pre-screening of patients pool for chronic disease trials. 
  • Assist in Clinical Trial Agreement.
  • Familiarize with the Sponsor's protocol
  • Assist PI in ICF process, screening, & randomization as per protocol inclusion exclusion criteria.
  • Assign Study subject numbers
  • Coordinate subject follow up visits preventing lost to follow up & missed visits
  • Manage drug accountability, distribution, destruction after expiry date.
  • Concomitant medications accountability
  • Design and maintain organizational tools (excel sheets, logs, forms, equipments, etc) to conduct the study accurately
  • IVRS Call, IWRS.
  • Phlebotomy or coordination of lab activities
  • Biological sample centrifugation/ separation
  • Biological sample shipment coordination
  • CRF/ eCRF entry
  • To maintain adequate source documentation
  • Coordinate Monitoring & Audit visits
  • Resolving DCFs within timelines
  • Coordinate telephonic monitoring visit
  • Reporting of Adverse Event in the Paper CRF & ECRF.
  • Subject reimbursements
  • Maintain and update Trial Master File
  • Maintain records of receipt, dispensing, and return of all clinical supplies
  • SAE reporting on time
  • Maintaining patient visit log as per the protocol and update to CRA
  • Submission of trial related documents to Ethics Committee as required

 

  • Coordinate close out visit
  • Resolve data queries
  • Submission of study close out letter to Ethics Committee
  • Archival of all study related documents at site

 

 

Operation Theatre :

The three operation theatres with state of the art equipment like Cell Saver, IABP, Ventricular Assist Device, Centrifugal pumps etc. and latest generation monitoring devices are specially designed to be free from bacteria with facilities even for Heart Transplant. All types of complex heart operations including, CABG, Total Arterial Revascularization, beating Heart Surgeries, Minimal Access Surgeries, Heart Valve Repair/ Replacement, Operation for Congenital Heart diseases in new born babies, Dynamic Cardiomyoplasty etc. are performed here. Vascular surgeries like Aneurysm repair, Carotid endarterectomy are also done here.

Catheterization Laboratory :

It consists of two labs with Computerized Cine Angiography equipment and with advance Automated Coronary Analysis Programmes and Haemodynamic Monitoring system. Procedures like Coronary and Peripheral Angiography, Peripheral Angioplasty, Balloon valvuloplasty, Coronary Angioplasty under Cardiopulmonary support, Implantation of permanent/temporary pacemaker and Balloon Septostomy are regularly performed here. Single and dual chamber Pacemaker Implantation, ICD implantation for rhythm disturbances and cardiac resynchronization therapy by biventricular pacing are also among the routine procedures. Electrophysiological study of heart and Radio frequency ablation study for treatment of atrial and ventricular arrhythmias is another activity undertaken in the lab.

Non-Invasive Department :

The non-invasive department of our centre provides facilities like Computerized electrocardiography, Computerized Stress test, Doppler Echocardiography, Dobutamine Stress Echocardiography, Trans-esophageal Echocardiography, Pulmonary Function Test including transfer factor, 24 hour Ambulatory Holter Monitor for cardiac monitoring. An advanced therapeutic modality EECP (External Enhanced Counter Pulsation) of modern era is now provided for cases of recurrent or refractory angina which are not suitable for bypass grafting or angioplasty.

Nuclear Cardiology & General Nuclear Medicine Department :

The department is equipped with latest generation Dual head Infinia Gamma Camera which provides high resolution images both for in-depth study of an organ, routine nuclear scintiscans and stress myocardial perfusion SPECT in a safe, painless cost effective technique. Apart from the heart, thyroid, bone, renal, lung and other organ scans are being done to get important functional information. Radio-iodine therapy for Thyrotoxicosis is also being done routinely.

Pathology Department :

The laboratory has various National accreditations like NABL (National Accredition of board of Laboratories), NABH (National Accreditation of Board of Hospitals) and the prestigious international accreditation of CAP (College of American Pathologist). These accreditations enforce various quality regulations on the tests performed and thus there is no compromise in terms of quality of the result. P.T (Proficiency Testing) samples from Biorad, Randox, AIIMS, CAP are received all the year round and our laboratory's performance is outstanding.

The department of Laboratory Services includes sections of Haematology, Clinical BioChemistry, Clinical Pathology, Molecular Pathology, Immunology & Serology, Microbiology, Histopathology, Cytopathology. Every section is equipped with state-of-art facilities and is actively involved in patient care.

The Department of Transfusion Medicine at this Institute was established in 1989 as a state-of-art facility to provide blood transfusion services. It is total dependant on voluntary blood donation and routine preparation of blood components are principal hallmarks of the department. According to the principles of Good Manufacturing Practices (GMP) strict adherence to quality control at all phases of donor selection, screening and processing of blood and serological procedures for grouping and typing of blood are followed.  The facility is licensed by the Drugs Controller of India.

Activities of this laboratory include: 

Donor blood processing: Tests for determining the ABO group & Rh type, detecting unexpected antibodies to red cell antigens, confirmation of Rh negative.

Cross matching: Routine tests include ABO grouping, Rh typing, antibody screening and identification. Requests for cross match for transfusion are processed with Microtyping card Gel Sytem. Tests for cold antibodies are done when necessary, viz for patients scheduled for open heart surgery, etc. 

Blood Component Laboratory: To exercise maximum economy in the use of Blood, every unit of blood is separated into various components, such as packed red cells, fresh frozen plasma, platelets. The laboratory has state-of-the-art equipment and technology.

Principal Investigators and Sub Investigators :

We have a panel of dedicated Principal Investigators and Co-Investigators who are into Clinical trials for several years and have sound knowledge of ICH-GCP. They are as follows:-

Dr. Anil Mishra MBBS (Cal), MRCP (UK), D. Card (Lond.), D. Card Medicine (Lond.)

Dr. Ashok B. Malpani (MD)

Dr. J.C. Sharma (MD)

Dr. Tanuja De MBBS, MD, MRCP (UK)

Dr. Dhiman Kahali MD (Cal), Dip. Card (Cal), DM (Cardiology)

Patient Demographics:

We have a diverse patient pool from various demographics. We also have huge patient referral pool from various Government Institutes. Patient recruitment is done with critical planning. Not only do patients from all over India seek treatment here, but patients from Bangladesh, Bhutan, Nepal, Mauritius, Hongkong, Kenya and other neighbouring countries also avail of its facilities. Our patient pool contains approximately - U/A-220 per month, NSTEMI-215 per month, PSVT-22 per month, DVT-5 per month, ACS- 265 per month.

Other Information:

We have an Institutional Ethics Committee (IEC), an independent body, for continuous approval of research protocols and significant protocol amendments, continuous review of clinical trial processes involving human subjects to protect the safety and well being of human research participants. The IEC operates as per standard SOP, ICH-GCP and ICMR guidelines. IEC meets on quarterly basis or earlier as required. The major activities of our clinical research team include evaluating new study feasibilities, assessing and facilitating recruitment and retention of current studies, and monitoring of protocol amendments, safety alerts and adverse events. As a result of this focused, team effort this center has been able to meet enrollment goals in a timely manner.

Contact Information :

Clinical Research Department

B.M. Birla Heart Research Centre

1/1, National Library Avenue

Kolkata-700027, West Bengal

INDIA

Phone: - 033-30403023, 033-24567006

Fax: - 033-24567000

E-mail id:- clinical.research@birlaheart.org