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Chettinad Hospital and Research Institute (CHRI)

Chettinad Centre for Drug Development and Clinical Trials (CDCT)

Chettinad Centre for Drug Development and Clinical Trials (CDCT) is a specialized department within Chettinad Hospital and Research Institute (CHRI), dedicated to the design, conduct, and management of clinical trials (both regulatory and academic clinical trials).

CDCT plays a critical role in advancing medical research and ensuring that new medical products are rigorously tested for their safety and efficacy before they are approved for general use.

The key functions of CDCT are:

  • Protocol development
  • Regulatory Compliance
  • Ethics Approval
  • Participant Recruitment and Retention
  • Data Management
  • Study Monitoring and Quality Assurance
  • Statistical Analysis
  • Reporting and Publication

Chettinad Hospital and Research Institute (CHRI)

Chettinad Centre for Drug Development and Clinical Trials (CDCT)

All the members of CDCT are well trained in Good Clinical Practice and other relevant regulatory guidelines.

Advisor
Dr. R. Sridhar, Vice-Chancellor and Professor of Respiratory Medicine

Director
Dr. R. Arunkumar, Vice-Principal and Professor & Head of Pharmacology

Lead Clinical Scientist
Dr. Mayilanandhi, Professor, Department of General Medicine

Head- Laboratory division
Dr. S. Priyadarshini, Lab Director and Professor & Head, Department of Microbiology

Lead Clinical Pharmacologist
Dr. E. Abinaya, Assistant Professor, Department of Pharmacology

Lead Epidemiologist
Dr. Jasmine, Assistant Professor, Department of Community Medicine

Lead Nano medicine Scientist
Dr. Ankush Chauhan, Assistant Professor, Faculty of Allied Health Sciences

Lead Molecular Biology Scientist
Dr. Rajasekaran Subbarayan, Assistant Professor Research

Other staff:

  • Principal Investigators from various departments
  • Clinical Research Co-coordinators
  • Biostatisticians
  • Pharmacists
  • Study nurses
  • Data Managers
  • QA coordinator
  • Lab technicians

Chettinad Hospital and Research Institute (CHRI)

Chettinad Centre for Drug Development and Clinical Trials (CDCT)

CDCT consists of the following areas dedicated solely for the trial purposes:

  • Reception
  • Counselling room
  • Ward (15 beds)
  • Room for sample collection and storage
  • IP storage room
  • Wet chemical laboratory
  • Instrumental Laboratory
  • Library
  • Documentation archival room
  • Facility for washing, cleaning and Toilets

Chettinad Hospital and Research Institute (CHRI)

Chettinad Centre for Drug Development and Clinical Trials (CDCT)

Clinical Pharmacology and Medical writing

Lead- Dr. E. Abinaya, Assistant Professor, Department of Pharmacology

  • The Clinical Pharmacology and Medical Writing Division is responsible development and evaluation of new therapeutic agents, ensuring their safety and efficacy through comprehensive pharmacokinetic and pharmacodynamic studies and producing high-quality documentation that supports the design, conduct, and reporting of clinical trials. This division ensures that all written materials are clear, accurate, and compliant with regulatory standards, ultimately facilitating the successful approval and dissemination of clinical trial results.
  • Key functions
    • Pharmacokinetic (PK) and Pharmacodynamic (PD) studies
    • Biomarker Identification and Validation
    • Clinical Trail design and Implementation
    • Protocol Development
    • Regulatory Document Preparation
    • Clinical Study Reports
    • Informed Consent Documents
    • Manuscript writing and Publication
    • Standard Operating Procedures (SOPs)
    • Patient Narratives and Case Reports

Clinical trials

Lead- Dr. Mayilananthi, Professor, Department of General Medicine

  • The clinical trial division manages the end-to-end process of clinical trials. This division ensures that trials are conducted efficiently, ethically, and in compliance with regulatory standards.
  • Key functions
    • Study Design and Protocol Development
    • Regulatory Submissions and Compliance
    • Site Management
    • Participant Recruitment and Retention
    • Data Management
    • Monitoring and Auditing
    • Safety Reporting
    • Study Close-Out and Reporting

Nanomedicine

Lead- Dr. Ankush Chauhan, Assistant Professor, Faculty of Allied Health Sciences

  • A nanomedicine division is responsible for the formulation and fabrication of the drugs to enhance the cell uptake efficacy and reducing toxicity using nanotechnology. This division involves the study of nanomedicines and fabrication of nano drugs from herbal phyto compounds.
  • Key functions
    • Research and Development (R&D) of Nanomaterials
    • Drug Delivery Systems
    • Diagnostic and Imaging Applications
    • Therapeutic Applications
    • Toxicology and Safety Assessment

Cellular Molecular Biology

Lead- Dr. Rajasekaran Subbarayan, Assistant Professor Research

  • o Cellular Molecular Biology plays a critical role in healthcare, bridging the gap between laboratory science and clinical medicine. Including, a role in the drug discovery, development, and testing of new medications, ensuring that these drugs are safe and effective for patient use. Here’s a detailed overview of the role is follows.
    • Drug discovery and Developments
    • Conduct research to identify new drug candidates
    • Utilize advanced techniques in molecular biology, biochemistry, and pharmacology to study drug interactions and mechanisms of action.
    • Design and conduct in vitro (cell-based) and in vivo (animal-based) studies to evaluate the safety and efficacy of drug candidates.
    • Collect and analyze data from clinical trials to assess drug efficacy and safety.
    • Maintain accurate and thorough documentation throughout the drug development process.
    • Work closely with multidisciplinary teams, including chemists, toxicologists, clinicians, and regulatory affairs specialists.

About

Chettinad Hospital and Research Institute (CHRI)

Chettinad Centre for Drug Development and Clinical Trials (CDCT)

Chettinad Centre for Drug Development and Clinical Trials (CDCT) is a specialized department within Chettinad Hospital and Research Institute (CHRI), dedicated to the design, conduct, and management of clinical trials (both regulatory and academic clinical trials).

CDCT plays a critical role in advancing medical research and ensuring that new medical products are rigorously tested for their safety and efficacy before they are approved for general use.

The key functions of CDCT are:

  • Protocol development
  • Regulatory Compliance
  • Ethics Approval
  • Participant Recruitment and Retention
  • Data Management
  • Study Monitoring and Quality Assurance
  • Statistical Analysis
  • Reporting and Publication

Team

Chettinad Hospital and Research Institute (CHRI)

Chettinad Centre for Drug Development and Clinical Trials (CDCT)

All the members of CDCT are well trained in Good Clinical Practice and other relevant regulatory guidelines.

Advisor
Dr. R. Sridhar, Vice-Chancellor and Professor of Respiratory Medicine

Director
Dr. R. Arunkumar, Vice-Principal and Professor & Head of Pharmacology

Lead Clinical Scientist
Dr. Mayilanandhi, Professor, Department of General Medicine

Head- Laboratory division
Dr. S. Priyadarshini, Lab Director and Professor & Head, Department of Microbiology

Lead Clinical Pharmacologist
Dr. E. Abinaya, Assistant Professor, Department of Pharmacology

Lead Epidemiologist
Dr. Jasmine, Assistant Professor, Department of Community Medicine

Lead Nano medicine Scientist
Dr. Ankush Chauhan, Assistant Professor, Faculty of Allied Health Sciences

Lead Molecular Biology Scientist
Dr. Rajasekaran Subbarayan, Assistant Professor Research

Other staff:

  • Principal Investigators from various departments
  • Clinical Research Co-coordinators
  • Biostatisticians
  • Pharmacists
  • Study nurses
  • Data Managers
  • QA coordinator
  • Lab technicians

Structure

Chettinad Hospital and Research Institute (CHRI)

Chettinad Centre for Drug Development and Clinical Trials (CDCT)

CDCT consists of the following areas dedicated solely for the trial purposes:

  • Reception
  • Counselling room
  • Ward (15 beds)
  • Room for sample collection and storage
  • IP storage room
  • Wet chemical laboratory
  • Instrumental Laboratory
  • Library
  • Documentation archival room
  • Facility for washing, cleaning and Toilets

Divisions

Chettinad Hospital and Research Institute (CHRI)

Chettinad Centre for Drug Development and Clinical Trials (CDCT)

Clinical Pharmacology and Medical writing

Lead- Dr. E. Abinaya, Assistant Professor, Department of Pharmacology

  • The Clinical Pharmacology and Medical Writing Division is responsible development and evaluation of new therapeutic agents, ensuring their safety and efficacy through comprehensive pharmacokinetic and pharmacodynamic studies and producing high-quality documentation that supports the design, conduct, and reporting of clinical trials. This division ensures that all written materials are clear, accurate, and compliant with regulatory standards, ultimately facilitating the successful approval and dissemination of clinical trial results.
  • Key functions
    • Pharmacokinetic (PK) and Pharmacodynamic (PD) studies
    • Biomarker Identification and Validation
    • Clinical Trail design and Implementation
    • Protocol Development
    • Regulatory Document Preparation
    • Clinical Study Reports
    • Informed Consent Documents
    • Manuscript writing and Publication
    • Standard Operating Procedures (SOPs)
    • Patient Narratives and Case Reports

Clinical trials

Lead- Dr. Mayilananthi, Professor, Department of General Medicine

  • The clinical trial division manages the end-to-end process of clinical trials. This division ensures that trials are conducted efficiently, ethically, and in compliance with regulatory standards.
  • Key functions
    • Study Design and Protocol Development
    • Regulatory Submissions and Compliance
    • Site Management
    • Participant Recruitment and Retention
    • Data Management
    • Monitoring and Auditing
    • Safety Reporting
    • Study Close-Out and Reporting

Nanomedicine

Lead- Dr. Ankush Chauhan, Assistant Professor, Faculty of Allied Health Sciences

  • A nanomedicine division is responsible for the formulation and fabrication of the drugs to enhance the cell uptake efficacy and reducing toxicity using nanotechnology. This division involves the study of nanomedicines and fabrication of nano drugs from herbal phyto compounds.
  • Key functions
    • Research and Development (R&D) of Nanomaterials
    • Drug Delivery Systems
    • Diagnostic and Imaging Applications
    • Therapeutic Applications
    • Toxicology and Safety Assessment

Cellular Molecular Biology

Lead- Dr. Rajasekaran Subbarayan, Assistant Professor Research

  • o Cellular Molecular Biology plays a critical role in healthcare, bridging the gap between laboratory science and clinical medicine. Including, a role in the drug discovery, development, and testing of new medications, ensuring that these drugs are safe and effective for patient use. Here’s a detailed overview of the role is follows.
    • Drug discovery and Developments
    • Conduct research to identify new drug candidates
    • Utilize advanced techniques in molecular biology, biochemistry, and pharmacology to study drug interactions and mechanisms of action.
    • Design and conduct in vitro (cell-based) and in vivo (animal-based) studies to evaluate the safety and efficacy of drug candidates.
    • Collect and analyze data from clinical trials to assess drug efficacy and safety.
    • Maintain accurate and thorough documentation throughout the drug development process.
    • Work closely with multidisciplinary teams, including chemists, toxicologists, clinicians, and regulatory affairs specialists.

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