CLINICAL RESEARCH SECRETARIAT &
DEPARTMENT OF ATOMIC ENERGY - CLINICAL TRIAL CENTRE

Empowering Clinical Research

INFRASTRUCTURE AND FACILITIES
Tata Memorial Hospital, Mumbai

CLINICAL TRIAL INFRASTRUCTURE AND EQUIPMENT
Commitment to Quality and Compliance: All listed equipment and facilities are periodically calibrated, validated, and maintained as per institutional SOPs and international standards. This rigorous quality assurance framework ensures the generation of accurate, reproducible, and regulatory-compliant clinical research data, reinforcing our commitment to excellence and participant safety.

Key Equipment and Facilities

  1. In-House CRS Pharmacy with Secure Drug Storage: A dedicated Clinical Research Services (CRS) pharmacy equipped with a secure and temperature-controlled drug storage unit. The facility is monitored 24/7 for temperature and humidity to ensure the safe handling, storage, and dispensing of investigational products in compliance with regulatory and ethical standards.
  2. ThermoHygrometer – Hygro L (Walk-in): Continuously monitors temperature and humidity within walk-in storage or incubation areas, ensuring controlled environmental conditions critical for sample stability and product integrity.
  3. Cooling Incubator (Walk-in): A walk-in temperature-controlled chamber for storing temperature-sensitive clinical samples, reagents, and biologics, ensuring consistency across research processes.
  4. Data Logger with NTC Sensor: Provides continuous electronic recording of temperature and humidity. Its NTC sensor ensures high accuracy, essential for validating controlled environments during audits.
  5. Health-O-Meter Plus Digital Scale: Ensures precise measurement of participant body weight, supporting accurate dosing and longitudinal health assessments.
  6. Height Scale: Used to measure participant height accurately for BMI calculations and anthropometric evaluations.
  7. Blood Pressure Monitor: Digital BP monitors for accurate and consistent measurement of systolic and diastolic pressure, essential for participant screening and safety monitoring.
  8. Weighing Machine: A dedicated scale located in the OPD area for standardized participant weight assessment during clinical visits.
  9. Blood Pressure Monitor: Provides accurate vital signs monitoring in the outpatient setting, supporting real-time clinical assessments.
  10. Basic and Advanced Life Support Crash Cart - for adverse event management: Advanced equipment for managing adverse events in clinical trials.

Advanced Diagnostic and Laboratory Equipment

  1. Infusion Pump: Delivers precise volumes of fluids or medications intravenously, ensuring accurate dosing during therapeutic interventions and infusion-based studies.
  2. Cytotoxic Cabinet: A biosafety cabinet designed for the safe preparation and handling of cytotoxic drugs, ensuring staff safety and contamination control.
  3. Ultrasonography (USG): Provides real-time imaging for diagnostic and interventional procedures, enabling non-invasive assessment of internal organs and treatment response.
  4. PET Scan I: Facilitates detailed metabolic imaging to assess tumor activity, treatment response, and disease progression.
  5. SPECT CT: Combines functional and anatomical imaging, aiding in precise localization and evaluation of disease processes.
  6. 2D Echocardiography: Used to evaluate cardiac function and structure, supporting safety monitoring in oncology and cardiotoxicity-related studies.
  7. Deep Freezer (-80°C): Maintains ultra-low temperatures for long-term storage of biological samples, preserving molecular stability and integrity.
  8. Centrifuge Universal 320: A versatile high-speed centrifuge used for processing blood and biological specimens, ensuring sample quality and reproducibility.
  9. Centrifuge - ambient temperature and Cryo Centrifuge: Used for routine sample separation and preparation in laboratory workflows, supporting multiple study protocols.
  10. Deep Freezer (-20°C): Preserves reagents and short-term biological samples under controlled temperature conditions.
  11. Mammography: Provides detailed breast imaging for diagnostic and screening studies, aiding in early detection and evaluation of therapeutic outcomes.
  12. CT Scan: Enables high-resolution cross-sectional imaging for accurate anatomical assessment and treatment planning.
  13. X-Ray: A fundamental diagnostic imaging tool used to assess bone and soft-tissue structures for various clinical and research applications.
  14. Portable X-Ray: Allows on-site imaging at patient bedside or field locations, supporting flexibility in participant assessment and safety monitoring.
  15. Bone Mineral Density (BMD) Scanner: Assesses bone health and density, particularly important in long-term therapeutic studies or trials involving bone-modifying agents.
  16. Magnetic Resonance Imaging (MRI): Provides high-resolution, non-invasive imaging for detailed evaluation of soft tissues, organs, and neurological structures.
  17. ECG – Philips TC 20: Records cardiac electrical activity for safety monitoring and detection of treatment-related cardiac effects. Regular calibration ensures high fidelity and accuracy.
  18. Electronic Laboratory Tests Requisition System with Auto-Printer Results System: Commitment to Quality and Compliance: All listed equipment and facilities are periodically calibrated, validated, and maintained as per institutional SOPs and international standards. This rigorous quality assurance framework ensures the generation of accurate, reproducible, and regulatory-compliant clinical research data, reinforcing our commitment to excellence and participant safety.

BIOSTATISTICIAN

The Department of Clinical Biostatistics (DCB) at Tata Memorial Centre (TMC) plays a pivotal role in supporting oncology research through robust statistical expertise.

It offers services under two main categories: consultation for short-term guidance (such as study design, sample size estimation, data analysis, and randomization), and collaboration for projects requiring deeper involvement (including protocol development, manuscript writing, and supervision of statistical analyses). Support is streamlined via an online requisition portal (https://forms.gle/RBkoZPMLepjswQvp6). The department also contributes to TMC’s academic mission by conducting postgraduate, PhD, fellowship, and certificate programs, alongside regular workshops and seminars to build research capacity. DCB actively supports initiatives such as Protocol Development Workshops (PDW), Research Mentors Group (RMG), systematic reviews and meta-analyses, and manages important data registries like BIRAC and ISBMT. With dedicated statisticians and trainees at ACTREC and TMH, the DCB fosters collaborative, methodologically sound research, and helps maintain the highest standards of scientific rigor across TMC.

Researchers can approach the department for above mentioned help and guidance. SOP of Department of Clinical Biostatistics (DCB) is uploaded for review and approach. Following service can be availed through the Department of Clinical Biostatistics (DCB) by the trained statisticians;

Tata Memorial Centre

The Department of Clinical Biostatistics (DCB) at Tata Memorial Centre plays a pivotal role in advancing cancer research by providing high-quality, objective statistical support and leadership. Our team of expert statisticians collaborates closely with clinicians and researchers across TMC to enhance the scientific rigor of research projects and improve patient outcomes. It offers services under two main categories: consultation for short-term guidance (such as study design, sample size estimation, data analysis, and randomization), and collaboration for projects requiring deeper involvement (including protocol development, manuscript writing, and supervision of statistical analyses).

Key Functions:

  • Statistical Consultation & Collaboration: DCB offers support for study design, sample size estimation, data analysis, database development (Excel, SPSS, REDCap), and randomization services. Statistical input is provided for DMG meetings, IEC submissions, conferences, and publications via a dedicated requisition portal.
  • Research Partnership: Statisticians from DCB contribute as co-investigators, help draft protocols, perform data analyses, assist in manuscript preparation, and mentor research teams across TMC.
  • Education & Training: DCB conducts workshops and delivers formal educational programs, including postgraduate diplomas, PhD mentorship, fellowships, and certificate courses in biostatistics.

Special Initiatives:

  • Statistical support for the Research Mentors Group (RMG)
  • Management of BIRAC and ISBMT registries
  • Involvement in Cochrane India Affiliate for systematic reviews and meta-analyses

Our Mission:

To promote the application of rigorous quantitative methods in cancer research, support TMC’s clinical and academic goals, and establish DCB as a national leader in biostatistical science.

Team:

Our team comprises experienced statisticians, scientific officers, and research fellows based at ACTREC and TMH. We also train biostatistics students through structured academic programs.

To request statistical support or learn more about our services, visit our portal: (https://forms.gle/RBkoZPMLepjswQvp6).

TRANSLATION

Clinical Trial Translation Facility – Tata Memorial Hospital

CRS has established an in-house Clinical Trial Translation Facility to support investigators in the conduct of high-quality, ethically robust, and regulatorily compliant clinical research. This centralized service is available to all Investigators at Tata Memorial Centre for the translation of Participant information Sheet and Informed Consent Documents (ICDs) and other clinical trial–related materials required for research studies and Ethics committee approval.

The facility ensures accurate, standardized, and quality-assured translations, with the objective of enhancing patient understanding, safeguarding participant rights, and maintaining consistency across multilingual research documentation. By providing institutional oversight and standardized processes, the service facilitates adherence to ethical guidelines and regulatory requirements applicable to clinical trials.

Investigators are strongly encouraged to utilize this in-house service for all translation requirements related to clinical research activities at TMC.

Requests for translation and further details regarding the service may be accessed through the following link:
https://redcap.link/crs_translation_service

This facility has been instituted to streamline research processes and support investigators in the effective and ethical conduct of clinical trials at Tata Memorial Centre.

Contact for more details:

Mrs. Pranjal N. Patil
Sr. Translator
Clinical Research Secretariat
Tata Memorial Hospital
Parel, Mumbai - 400 012
Phone : 022-24177000 - Extn. : 4266

REDCap Facility and Services – Tata Memorial Hospital

Tata Memorial Hospital (TMH) offers a centralized REDCap (Research Electronic Data Capture) Facility to support investigators in the secure, efficient, and compliant management of research and clinical trial data. REDCap is a secure, web-based platform widely used for building and managing online databases and surveys for clinical trials, registries, audits, and academic research projects.

The TMH REDCap Facility provides institutional access to the REDCap platform along with technical oversight, governance, and user support. This ensures data security, integrity, confidentiality, and compliance with institutional, ethical, and regulatory requirements. The facility is available to all TMH investigators, research staff, and students involved in approved research activities.

Services and Associated Facilities Available at TMH

The REDCap Facility at TMH provides the following comprehensive services:

  • REDCap account creation and user access management
  • Project setup and database design for clinical trials, registries, audits, and observational studies
  • Online survey development for patient-reported outcomes and questionnaires
  • Secure data capture and storage with role-based access controls
  • Audit trails for monitoring data entry, modifications, and exports
  • Randomization module for interventional clinical trials
  • Longitudinal and event-based study design support
  • Data validation rules and built-in quality checks
  • Data export to statistical software (SPSS, SAS, R, Stata, Excel, etc.)
  • Multi-site collaboration and data sharing support
  • Adherence to institutional data governance and security policies
  • User training, guidance, and ongoing technical support

REDCap Account Creation

Investigators who wish to use REDCap at TMH must request an official REDCap account through the institutional process.

To apply for REDCap account creation, please click the link below and submit the request form:
https://redcap.link/redcap_request_form

The REDCap Facility at Tata Memorial Hospital is committed to enabling high-quality, secure, and efficient data management, thereby supporting investigators in the successful conduct of clinical research and academic activities.

Contact for more details:

Dr Manoj Gorade
Scientific Officer C
Clinical Research Secretariat
3rd Floor Main Building,
Tata Memorial Hospital, Parel Mumbai
Phone : 022-24177000- Extn. : 4266
Email : software-crs.tmh@tmc.gov.in

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