Clinical Research
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Clinical research involves systematically studying new drugs in human subjects to discover and verify their safety, efficacy, clinical effects, and adverse reactions. Careers in clinical research include clinical research associate, clinical research coordinator, clinical investigator, medical advisor, biostatistician, data manager, clinical trial auditor, medical writer, and clinical research trainer. Clinical research work involves clinical trial processes and operations, clinical data management, medical writing, pharmacovigilance, regulatory affairs, and quality assurance.
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Introduction to clinical research
Clinical research involves systematic studies in human subjects to improve quality of life. Clinical trials are a form of clinical research that experimentally tests medications, devices, or biologics to evaluate safety and effectiveness. There are different phases of clinical trials, from small early phase safety studies to larger late phase studies to establish efficacy. Clinical trials require many players including regulators, sponsors, investigators, ethics committees, and participants to design, monitor, and conduct the trials according to strict protocols to safely and effectively evaluate potential new treatments.
CLINICAL TRIAL PROTOCOL
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Investigational New drug application [INDA]
An IND is a submission to the food and drug administration (FDA) requesting permission to initiate a clinical study of a new drug product.
Clinical trials
Clinical trials involve testing investigational drugs or treatments on human subjects to determine safety and efficacy. They progress through several phases, beginning with small pre-clinical trials on animals. Phase 1 trials involve 20-50 healthy volunteers to assess pharmacokinetics and safety. Phase 2 trials enroll 50-300 patient volunteers to further evaluate safety and dosage. Phase 3 trials are large randomized controlled trials of 250-1000+ subjects comparing the investigational treatment to standard treatment or placebo. If Phase 3 is successful, the results are submitted to regulatory agencies for approval to market the new drug. Post-marketing Phase 4 trials monitor long-term safety and efficacy.
Introduction to Clinical trial
This document outlines the phases of clinical drug trials. It discusses the objectives and methods of each phase. Phase I trials test drug safety in healthy volunteers. Phase II trials test efficacy and side effects in patients to determine dosage. Phase III trials test efficacy and safety in large randomized controlled trials. Phase IV trials monitor drug use after marketing to detect rare or long-term effects. Each phase uses different doses, patients, investigators, and sample sizes to progressively evaluate a drug's safety and effectiveness in humans. The overall goal is to translate preclinical animal findings into cautious human testing.
ICH GCP
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
CONTRACT RESEARCH ORGANIZATION
Introduction to CONTRACT RESEARCH ORGANIZATION, Background, Over all view of CRO
Presented by
G.Aravind Kumar
Department of Industrial Pharmacy
CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATION
CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATIONR.C patel institute of pharmacutical education and research, shirpur
The Central Drug Standard Control Organisation (CDSCO) is India's main drug regulatory body. It regulates pharmaceuticals, medical devices, and clinical trials. CDSCO functions under the Ministry of Health and Family Welfare. It oversees drug approval processes, clinical trial approval, import/export of drugs, medical devices regulation, and operates an online licensing portal called SUGAM. CDSCO's head office is in New Delhi and it has various zonal, sub-zonal, and port offices that perform regulatory functions like GMP audits and sample testing.Recommended
Introduction to clinical research
Clinical research involves systematic studies in human subjects to improve quality of life. Clinical trials are a form of clinical research that experimentally tests medications, devices, or biologics to evaluate safety and effectiveness. There are different phases of clinical trials, from small early phase safety studies to larger late phase studies to establish efficacy. Clinical trials require many players including regulators, sponsors, investigators, ethics committees, and participants to design, monitor, and conduct the trials according to strict protocols to safely and effectively evaluate potential new treatments.
CLINICAL TRIAL PROTOCOL
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Investigational New drug application [INDA]
An IND is a submission to the food and drug administration (FDA) requesting permission to initiate a clinical study of a new drug product.
Clinical trials
Clinical trials involve testing investigational drugs or treatments on human subjects to determine safety and efficacy. They progress through several phases, beginning with small pre-clinical trials on animals. Phase 1 trials involve 20-50 healthy volunteers to assess pharmacokinetics and safety. Phase 2 trials enroll 50-300 patient volunteers to further evaluate safety and dosage. Phase 3 trials are large randomized controlled trials of 250-1000+ subjects comparing the investigational treatment to standard treatment or placebo. If Phase 3 is successful, the results are submitted to regulatory agencies for approval to market the new drug. Post-marketing Phase 4 trials monitor long-term safety and efficacy.
Introduction to Clinical trial
This document outlines the phases of clinical drug trials. It discusses the objectives and methods of each phase. Phase I trials test drug safety in healthy volunteers. Phase II trials test efficacy and side effects in patients to determine dosage. Phase III trials test efficacy and safety in large randomized controlled trials. Phase IV trials monitor drug use after marketing to detect rare or long-term effects. Each phase uses different doses, patients, investigators, and sample sizes to progressively evaluate a drug's safety and effectiveness in humans. The overall goal is to translate preclinical animal findings into cautious human testing.
ICH GCP
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
CONTRACT RESEARCH ORGANIZATION
Introduction to CONTRACT RESEARCH ORGANIZATION, Background, Over all view of CRO
Presented by
G.Aravind Kumar
Department of Industrial Pharmacy
CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATION
CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATIONR.C patel institute of pharmacutical education and research, shirpur
The Central Drug Standard Control Organisation (CDSCO) is India's main drug regulatory body. It regulates pharmaceuticals, medical devices, and clinical trials. CDSCO functions under the Ministry of Health and Family Welfare. It oversees drug approval processes, clinical trial approval, import/export of drugs, medical devices regulation, and operates an online licensing portal called SUGAM. CDSCO's head office is in New Delhi and it has various zonal, sub-zonal, and port offices that perform regulatory functions like GMP audits and sample testing.Clinical research
Clinical trials are research studies that test new medical treatments and drugs on human volunteers. They are important for discovering new treatments and determining what is safe and effective for human use. There are different types of clinical trials including observational studies that monitor participants' health over time without interventions, and interventional studies that test new drugs, therapies or treatments. Clinical trials go through several phases and are tightly regulated to protect participants and ensure scientific validity.
Clinical Trial Phases
Clinical trials involve several phases:
- Phase I trials involve small groups of healthy volunteers or patients and aim to determine the safety and tolerability of a new drug.
- Phase II trials involve larger groups of patients and aim to determine efficacy and further evaluate safety. These trials provide preliminary data on effectiveness.
- Phase III trials involve even more patients and aim to confirm effectiveness, monitor side effects, and compare the new treatment to standard treatment. These trials provide the primary data to support effectiveness. Regulatory approval is based on positive Phase III results showing safety and effectiveness.
ICH GCP guidelines
This document reviews Good Clinical Practice (GCP) guidelines. It aims to study GCP principles and their application. The document outlines the objectives, contents, and introduction to GCP. It describes 14 GCP principles regarding ethical conduct of clinical trials, including protocol development, risk identification, benefit-risk assessment, review by ethics committees, informed consent, qualifications of investigators and staff, record keeping, confidentiality, manufacturing standards, and quality systems. The document provides examples of how each principle is applied in clinical research. It concludes with a bibliography on GCP guidelines and resources.
Clinical trial protocol development
This document outlines the key components and considerations for developing a clinical trial protocol. It discusses that a protocol is a complete written plan for a research study involving human subjects. It identifies important sections such as the title page, objectives, study design, safety reporting, statistical analysis, and informed consent. It emphasizes that the protocol language should be clear, concise, and understandable for diverse readers. It also provides guidance on properly writing eligibility criteria, adverse event definitions, and obtaining informed consent to protect human subjects.
Clinical research
Clinical research involves investigating medical treatments and devices with human subjects to determine safety and effectiveness, and can include clinical trials, mechanisms of disease, and outcomes research. A sponsor initiates and finances clinical trials and is responsible for selecting qualified investigators, while investigators ensure ethical conduct of the trial and respect for subjects. Clinical research associates support investigators and sponsors in carrying out clinical trials.
Cdsco ppt
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is responsible for approving new drugs, medical devices, and clinical trials. CDSCO has headquarters in New Delhi and is overseen by the Drug Controller General of India. It has various zonal and sub-zonal offices that perform GMP audits, inspections, and quality control tests. CDSCO uses a multi-step process to approve clinical trials, drugs, cosmetics, and medical devices that involves submitting documents and gaining permission from the DCGI. It also has an online portal called SUGAM to streamline the application process.
Clinical research protocol
This document outlines a clinical research protocol template. It begins with an introduction section defining clinical research and clinical trials. It then describes the purpose and contents of a clinical research protocol, including sections for objectives, background/rationale, study design, eligibility criteria, treatments, assessments, data collection and analysis, monitoring, ethics and regulations. The protocol template provides guidance on the level of detail needed for each section to clearly explain the research question, methodology, and procedures to ensure scientific validity and participant safety.
ICH-GCP Guidelines
The document provides an overview of ICH-GCP (Good Clinical Practice) guidelines, which are international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects. The summary discusses the key sections and principles of ICH-GCP, which aim to protect trial subjects and ensure valid clinical trial data. It outlines the historical background and development of GCP standards from the Nuremberg Code to the ICH-GCP guidelines of 1996. The document reviews responsibilities of ethics committees, sponsors, investigators, clinical trial protocols, and informed consent processes.
clinical trials types and design
Clinical trials are conducted to test new drugs, treatments or medical devices in humans to assess their safety and efficacy. There are four main phases of clinical trials:
Phase I trials involve small groups of people to determine basic safety and dosing requirements. Phase II trials expand the testing to more people to determine efficacy and further evaluate safety. Phase III trials involve large groups of people to confirm effectiveness, monitor side effects, compare to commonly used treatments and collect information to allow safe use of the intervention. Phase IV trials occur after the intervention has been marketed to gather information on effects in various populations and any long-term side effects.
ind
The document discusses an Investigational New Drug Application (IND), which is a submission to the FDA requesting permission to study an experimental drug in clinical trials. An IND provides safety data from animal studies and details of the proposed clinical trials. It includes information on the drug's chemistry, manufacturing, pharmacology and any previous human experience. The IND process allows a drug to move through preclinical and clinical testing in humans while being monitored by the FDA to ensure the protection of clinical trial subjects.
Phases in clinical trial
The document outlines the phases of clinical trials:
- Phase 0 involves microdosing to determine pharmacokinetics and pharmacodynamics.
- Phase 1 studies a drug's safety on 20-100 healthy volunteers and finds the optimal dose.
- Phase 2 trials on 100-300 people study a drug's biological effects and continues safety monitoring. It has two types: 2a determines dosing and 2b is pivotal, blinded, and multicenter.
- Phase 3 are large randomized controlled trials on 300-3000 people comparing a drug to standard treatment. It has two types: 3a tests different indications and 3b continues trials pending regulatory approval.
- Phase 4 occurs after approval to detect rare adverse effects
Institutional review board by akshdeep sharma
The Institutional Review Board/Independent Ethics Committee (IRB/IEC) serves as an independent body that reviews and approves clinical trials to protect participant safety and rights. The IRB/IEC consists of at least five members with diverse qualifications to evaluate scientific and ethical aspects of trials. The IRB/IEC's responsibilities include reviewing trials, providing continuing oversight, ensuring informed consent, and maintaining records for regulatory review.
Clinical Research Presentation
Clinical research involves conducting research studies in human volunteers to answer health questions and find new treatments. It typically involves several phases from preclinical testing in animals to clinical trials in human subjects. India is emerging as a global hub for clinical research due to its large patient pools, low costs, and trained professionals. However, there is a large gap between the growing demand for trained clinical research professionals and current supply. Cliniminds aims to address this need by providing a wide range of clinical research training programs and courses.
Medical writing in clinical research
Medical writing involves producing scientific documentation for clinical research in a clear, standardized manner. It includes regulatory writing for submissions to authorities, educational writing for various audiences, and medical marketing. Good medical writers have scientific backgrounds and abilities to research topics, think logically, and communicate complex information clearly to different audiences. They follow steps like reviewing information and receiving approvals when writing documents and ensure compliance with relevant guidelines and regulations.
INVESTIGATOR’S BROCHURE (IB)
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Clinical trials its types and designs
clinical trials- definition
types of clinical trials
various designs of clinical trials such as observational design and intervention design.
institutional review board and independent ethics committee
The document discusses the role and responsibilities of institutional review boards (IRBs) in protecting human subjects in clinical research. It provides details on:
- The composition and quorum requirements of IRBs, including the need for diverse expertise and community representation.
- The functions of IRBs, which include reviewing research protocols, approving studies, overseeing informed consent processes, and ensuring ongoing ethical review of approved studies.
- The responsibilities of IRBs in evaluating risks and benefits to research participants, assessing payment amounts and methods, and requiring modifications or halting studies when necessary.
- The necessary components of informed consent forms used in clinical studies, including study details, risks/benefits, confidentiality
Clinical trial monitoring
Monitoring in clinical trials serves several key purposes: to protect the rights and welfare of human subjects, ensure the accuracy and completeness of trial data, and confirm compliance with regulatory standards and the study protocol. There are various types of monitoring, including central monitoring of data for unusual patterns, risk-based monitoring focusing on higher risk aspects, and on-site monitoring to check participant enrollment and informed consent, study conduct, drug accountability, and accuracy of source data documentation. Routine monitoring visits evaluate study progress, resources, laboratory facilities, investigational products, compliance with the protocol and regulations, case report forms, source data verification, adverse events documentation, and regulatory files.
Good Clinical Practice (GCP)
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
Clinical Data Management
An brief introduction to the clinical data management process is described in this slides. These slides provides you the information regarding the data evaluation in the clinical trials , edit checks and data review finally data locking,then the data is submitted to the concerned regulatory body.
Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / ...
Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / ...SOCRA CCRP Certification
SOCRA study guide - ES’ SOCRA CCRP Exam Study Guide – A resource to help those who is preparing for the SOCRA Certified Clinical Research Professional (CCRP) certification.Healthcare &Pharmaceutical
The document discusses the healthcare and pharmaceutical industries. The healthcare industry provides goods and services for curative, preventive, rehabilitative, and palliative care and includes medical equipment, supplies, and healthcare services like hospitals and nursing homes. The pharmaceutical industry develops, produces, and markets drugs and deals in generic and brand medications. Some reputable healthcare companies mentioned are Sanofi, Hoffman la Roche, Johnson and Johnson, and Novartis, while reputable pharmaceutical companies include Catalent MSP, DuPont, BASF, and Amgen. Important roles in the industries include scientist, chemist, laboratory technician, clinical trials manager, nurse, and research associate.
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Clinical research
Clinical trials are research studies that test new medical treatments and drugs on human volunteers. They are important for discovering new treatments and determining what is safe and effective for human use. There are different types of clinical trials including observational studies that monitor participants' health over time without interventions, and interventional studies that test new drugs, therapies or treatments. Clinical trials go through several phases and are tightly regulated to protect participants and ensure scientific validity.
Clinical Trial Phases
Clinical trials involve several phases:
- Phase I trials involve small groups of healthy volunteers or patients and aim to determine the safety and tolerability of a new drug.
- Phase II trials involve larger groups of patients and aim to determine efficacy and further evaluate safety. These trials provide preliminary data on effectiveness.
- Phase III trials involve even more patients and aim to confirm effectiveness, monitor side effects, and compare the new treatment to standard treatment. These trials provide the primary data to support effectiveness. Regulatory approval is based on positive Phase III results showing safety and effectiveness.
ICH GCP guidelines
This document reviews Good Clinical Practice (GCP) guidelines. It aims to study GCP principles and their application. The document outlines the objectives, contents, and introduction to GCP. It describes 14 GCP principles regarding ethical conduct of clinical trials, including protocol development, risk identification, benefit-risk assessment, review by ethics committees, informed consent, qualifications of investigators and staff, record keeping, confidentiality, manufacturing standards, and quality systems. The document provides examples of how each principle is applied in clinical research. It concludes with a bibliography on GCP guidelines and resources.
Clinical trial protocol development
This document outlines the key components and considerations for developing a clinical trial protocol. It discusses that a protocol is a complete written plan for a research study involving human subjects. It identifies important sections such as the title page, objectives, study design, safety reporting, statistical analysis, and informed consent. It emphasizes that the protocol language should be clear, concise, and understandable for diverse readers. It also provides guidance on properly writing eligibility criteria, adverse event definitions, and obtaining informed consent to protect human subjects.
Clinical research
Clinical research involves investigating medical treatments and devices with human subjects to determine safety and effectiveness, and can include clinical trials, mechanisms of disease, and outcomes research. A sponsor initiates and finances clinical trials and is responsible for selecting qualified investigators, while investigators ensure ethical conduct of the trial and respect for subjects. Clinical research associates support investigators and sponsors in carrying out clinical trials.
Cdsco ppt
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is responsible for approving new drugs, medical devices, and clinical trials. CDSCO has headquarters in New Delhi and is overseen by the Drug Controller General of India. It has various zonal and sub-zonal offices that perform GMP audits, inspections, and quality control tests. CDSCO uses a multi-step process to approve clinical trials, drugs, cosmetics, and medical devices that involves submitting documents and gaining permission from the DCGI. It also has an online portal called SUGAM to streamline the application process.
Clinical research protocol
This document outlines a clinical research protocol template. It begins with an introduction section defining clinical research and clinical trials. It then describes the purpose and contents of a clinical research protocol, including sections for objectives, background/rationale, study design, eligibility criteria, treatments, assessments, data collection and analysis, monitoring, ethics and regulations. The protocol template provides guidance on the level of detail needed for each section to clearly explain the research question, methodology, and procedures to ensure scientific validity and participant safety.
ICH-GCP Guidelines
The document provides an overview of ICH-GCP (Good Clinical Practice) guidelines, which are international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects. The summary discusses the key sections and principles of ICH-GCP, which aim to protect trial subjects and ensure valid clinical trial data. It outlines the historical background and development of GCP standards from the Nuremberg Code to the ICH-GCP guidelines of 1996. The document reviews responsibilities of ethics committees, sponsors, investigators, clinical trial protocols, and informed consent processes.
clinical trials types and design
Clinical trials are conducted to test new drugs, treatments or medical devices in humans to assess their safety and efficacy. There are four main phases of clinical trials:
Phase I trials involve small groups of people to determine basic safety and dosing requirements. Phase II trials expand the testing to more people to determine efficacy and further evaluate safety. Phase III trials involve large groups of people to confirm effectiveness, monitor side effects, compare to commonly used treatments and collect information to allow safe use of the intervention. Phase IV trials occur after the intervention has been marketed to gather information on effects in various populations and any long-term side effects.
ind
The document discusses an Investigational New Drug Application (IND), which is a submission to the FDA requesting permission to study an experimental drug in clinical trials. An IND provides safety data from animal studies and details of the proposed clinical trials. It includes information on the drug's chemistry, manufacturing, pharmacology and any previous human experience. The IND process allows a drug to move through preclinical and clinical testing in humans while being monitored by the FDA to ensure the protection of clinical trial subjects.
Phases in clinical trial
The document outlines the phases of clinical trials:
- Phase 0 involves microdosing to determine pharmacokinetics and pharmacodynamics.
- Phase 1 studies a drug's safety on 20-100 healthy volunteers and finds the optimal dose.
- Phase 2 trials on 100-300 people study a drug's biological effects and continues safety monitoring. It has two types: 2a determines dosing and 2b is pivotal, blinded, and multicenter.
- Phase 3 are large randomized controlled trials on 300-3000 people comparing a drug to standard treatment. It has two types: 3a tests different indications and 3b continues trials pending regulatory approval.
- Phase 4 occurs after approval to detect rare adverse effects
Institutional review board by akshdeep sharma
The Institutional Review Board/Independent Ethics Committee (IRB/IEC) serves as an independent body that reviews and approves clinical trials to protect participant safety and rights. The IRB/IEC consists of at least five members with diverse qualifications to evaluate scientific and ethical aspects of trials. The IRB/IEC's responsibilities include reviewing trials, providing continuing oversight, ensuring informed consent, and maintaining records for regulatory review.
Clinical Research Presentation
Clinical research involves conducting research studies in human volunteers to answer health questions and find new treatments. It typically involves several phases from preclinical testing in animals to clinical trials in human subjects. India is emerging as a global hub for clinical research due to its large patient pools, low costs, and trained professionals. However, there is a large gap between the growing demand for trained clinical research professionals and current supply. Cliniminds aims to address this need by providing a wide range of clinical research training programs and courses.
Medical writing in clinical research
Medical writing involves producing scientific documentation for clinical research in a clear, standardized manner. It includes regulatory writing for submissions to authorities, educational writing for various audiences, and medical marketing. Good medical writers have scientific backgrounds and abilities to research topics, think logically, and communicate complex information clearly to different audiences. They follow steps like reviewing information and receiving approvals when writing documents and ensure compliance with relevant guidelines and regulations.
INVESTIGATOR’S BROCHURE (IB)
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Clinical trials its types and designs
clinical trials- definition
types of clinical trials
various designs of clinical trials such as observational design and intervention design.
institutional review board and independent ethics committee
The document discusses the role and responsibilities of institutional review boards (IRBs) in protecting human subjects in clinical research. It provides details on:
- The composition and quorum requirements of IRBs, including the need for diverse expertise and community representation.
- The functions of IRBs, which include reviewing research protocols, approving studies, overseeing informed consent processes, and ensuring ongoing ethical review of approved studies.
- The responsibilities of IRBs in evaluating risks and benefits to research participants, assessing payment amounts and methods, and requiring modifications or halting studies when necessary.
- The necessary components of informed consent forms used in clinical studies, including study details, risks/benefits, confidentiality
Clinical trial monitoring
Monitoring in clinical trials serves several key purposes: to protect the rights and welfare of human subjects, ensure the accuracy and completeness of trial data, and confirm compliance with regulatory standards and the study protocol. There are various types of monitoring, including central monitoring of data for unusual patterns, risk-based monitoring focusing on higher risk aspects, and on-site monitoring to check participant enrollment and informed consent, study conduct, drug accountability, and accuracy of source data documentation. Routine monitoring visits evaluate study progress, resources, laboratory facilities, investigational products, compliance with the protocol and regulations, case report forms, source data verification, adverse events documentation, and regulatory files.
Good Clinical Practice (GCP)
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
Clinical Data Management
An brief introduction to the clinical data management process is described in this slides. These slides provides you the information regarding the data evaluation in the clinical trials , edit checks and data review finally data locking,then the data is submitted to the concerned regulatory body.
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institutional review board and independent ethics committee
institutional review board and independent ethics committee
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The document discusses the healthcare and pharmaceutical industries. The healthcare industry provides goods and services for curative, preventive, rehabilitative, and palliative care and includes medical equipment, supplies, and healthcare services like hospitals and nursing homes. The pharmaceutical industry develops, produces, and markets drugs and deals in generic and brand medications. Some reputable healthcare companies mentioned are Sanofi, Hoffman la Roche, Johnson and Johnson, and Novartis, while reputable pharmaceutical companies include Catalent MSP, DuPont, BASF, and Amgen. Important roles in the industries include scientist, chemist, laboratory technician, clinical trials manager, nurse, and research associate.
Demystifying clinical-trials
The document provides an introduction to clinical trials and demystifies some common misconceptions. It is written by Dan Sfera, owner of a clinical trial research clinic, to educate people considering participating in a clinical trial. The document defines what clinical trials are, explains their various phases and purposes, and discusses participant safety, rights, informed consent, and other topics to empower readers to make their own informed choices about trials.
Career in clinical research
The clinical research industry in India is growing rapidly due to the booming pharmaceutical sector. The Indian pharmaceutical market is expected to triple in size by 2015. This growth has fueled a rise in clinical research opportunities in India. However, the clinical research industry faces high attrition rates. There is a high demand for trained clinical research professionals to work for the growing number of contract research organizations. Focus Edu Care has launched a postgraduate program in clinical research to train professionals to meet this demand and fill various roles in areas like clinical research, data management, business development, and medical writing.
Biochemist
Caitlin Ward is a biochemist who researches human diseases and develops new drugs and treatments. Her education includes a bachelor's degree in biochemistry, biology or chemistry, as well as a Ph.D. in biological science. As a biochemist, she performs tasks like weighing chemicals, filtering liquids, and growing microorganism cultures in a lab setting using tools such as test tubes, beakers, and electron microscopes. Her work involves running trials, analyzing data, and developing conclusions and new drugs based on her research findings.
Role & responsibilities of a clinical research coordinator
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Careers In Clinical Research
The document provides information about opportunities in the clinical research industry. It discusses what clinical research is and the drug development process. It outlines the growing industry opportunity, with increasing demand for clinical research professionals and rapid investment growth in the field. Various career opportunities and paths in clinical research are also presented, along with salary ranges and eligibility requirements to work in clinical research.
Clinical research ppt,
The document discusses the basics of clinical research and clinical trials. It covers the key steps in drug discovery and development including target selection, validation, drug selection, optimization, pre-clinical and clinical testing. Clinical trials are systematic investigations in human subjects to evaluate safety and efficacy of new drugs, and are done in 4 phases. It takes approximately 10-12 years and $800 million to bring a new drug to market. Regulations, stakeholders, essential documents, and infrastructure requirements for clinical trials are also outlined.
Clinical Trials - An Introduction
This presentation will give an overview of the Clinical Research/Drug Development and licensing(US FDA) process. Please feel free to provide feedback.
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The document outlines a program in clinical trials, research, and data management consisting of 7 modules. Module I discusses clinical trials and the clinical trials environment. Module II covers statistics for clinical trials. Module III is about clinical data management. Module IV is on contract research. Module V addresses regulatory affairs, good clinical practices, pharmacovigilance, and ethics. Module VI is on practical medical writing and documentation. Module VII provides skills for conducting research studies. The program aims to provide skills for careers in clinical research.
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Clinical research involves organized studies on human subjects to evaluate the safety and efficacy of new drugs, medical devices, and other therapies. It is a critical part of the drug development process, accounting for two-thirds of the total time and costs. India has become an attractive location for clinical research due to its low-cost yet skilled workforce, large patient populations, and established expertise in pharmaceuticals and business processes. The clinical research sector in India is growing rapidly, driven by global outsourcing trends and capabilities within the Indian pharmaceutical industry.
quality management systems: Total quality management & Quality by design
Total quality management (TQM) and quality by design (QbD) are important approaches for maintaining quality in the pharmaceutical industry. TQM focuses on continuous improvement and prevention of defects rather than detection. It involves strategic commitment, employee involvement, and precise techniques. QbD is a systematic approach that includes prior product and process understanding to design quality into the manufacturing process from the beginning. The main objectives of QbD are increasing efficiency, enhancing product quality, and avoiding regulatory issues. It involves defining quality target profiles, identifying critical quality attributes, assessing risks, and establishing control strategies.
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The document discusses the various career opportunities available across the drug development process. It describes the stages of drug development from discovery through clinical testing, licensure, manufacturing, and marketing. At each stage, it outlines the personnel required such as chemists, clinical researchers, regulatory specialists, and sales representatives, as well as the typical educational degree requirements which range from associate's degrees to PhDs. The drug development process ultimately aims to bring new drugs from the laboratory through clinical trials to approval and production for patients.
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Martha Schmidt has over 20 years of experience in clinical research, drug development, and the medical field. She has worked for several large pharmaceutical companies, managing clinical trials and ensuring regulatory compliance. She is knowledgeable about all phases of drug development and has experience in clinical oncology. Schmidt has extensive expertise in clinical data review and analysis. She is passionate about assisting with product liability and medical malpractice litigation through case review and serving as an expert witness.
PMS and Outsourcing - Copy.pptx
Post-marketing surveillance involves monitoring drug safety after market release. It identifies rare or long-term adverse effects not seen in clinical trials. Manufacturers must report serious adverse events to regulatory agencies. Outsourcing bioavailability and bioequivalence studies to contract research organizations allows companies to access expertise and resources while reducing costs and time to market. CROs conduct clinical trials, data analysis, and reporting according to Good Clinical Practice standards. Qualification of appropriate CROs involves assessing capabilities, infrastructure, compliance history, and collaboration effectiveness.
Quality, Risk & Compliance: Risk Management for Sponsors, Site, and CROs
This document discusses risk management in clinical trials from multiple perspectives. It provides statistics on the high costs and time required to bring new drugs to market. It defines quality as an absence of errors that matter and compliance as adherence to regulatory and GCP requirements. Key aspects of risk management are identified, including risk identification, evaluation, control, and review. Process mapping and risk assessment tools are presented. Quality by design and continual improvement concepts are also covered.
Ich
The International Council for Harmonisation (ICH) is a joint initiative between regulators and the pharmaceutical industry to harmonize technical requirements for drug registration. The goal is to streamline development, eliminate redundant testing, and make new medicines available more quickly while maintaining standards of safety and efficacy. ICH involves six regulatory and industry parties working to produce unified guidelines for the European Union, Japan, and United States on quality, safety, and efficacy. This helps facilitate mutual acceptance of clinical data between jurisdictions.
Pharmaceutical Regulaions; Emergence & Complexity
Guest Speaker to MSc, students
Health Reforms of Health Policy & Management
Aga Khan University and Hospital, Karachi
Laboratory Activ Participant To Clinical Trials [Tryb ZgodnośCi]
This document discusses the role of clinical laboratories in clinical trials. It begins by defining clinical trials and describing their various phases. It then outlines the major players in clinical trials, including sponsors, contract research organizations, site management organizations, and investigators. The role of clinical laboratories is described, including how they can help at the sponsor, monitor, and investigator levels by providing expertise in study design, sample handling, and training. The document emphasizes that audits are required for laboratories to participate in clinical trials and outlines guidelines for auditing clinical laboratories. It also discusses trends in the clinical research industry toward central laboratories for improved data quality and processing. In conclusion, it addresses the balance between local laboratories and central laboratories in clinical trials.
VAC3 Corporate Presentation
VAC3 Clinical Services is an Indian clinical research organization established in 2010 that provides global standard clinical and medical services including medical writing, clinical research, investigator selection and training, and regulatory consultation, focusing on therapeutic areas like oncology, cardiology, and neurology. Their team of experts have decades of experience in areas like clinical research, drug development, and medical marketing. They have conducted seminars on topics like drug development processes and ethics in clinical research.
Eyf webinar sepa career fair 2010
The document provides an overview of careers in the biopharmaceutical industry. It describes the long process of developing new drugs, which involves identifying drug targets, designing and testing compounds, conducting preclinical and clinical trials, gaining regulatory approval, and post-launch monitoring. Many roles are needed across research, development, manufacturing, regulatory affairs, sales, and other functions. The average time to get a new drug to market is 14 years and over $1 billion.
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...
Regulatory compliance is a crucial aspect of conducting clinical research, ensuring that studies meet the requirements and standards set by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and other relevant bodies. Here are some key points to navigate regulatory compliance in clinical research:
Familiarize Yourself with Applicable Regulations: Stay updated on the relevant regulations and guidelines that govern clinical research, including FDA regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and local regulatory requirements. Understand the specific regulations that apply to your study, such as those related to investigational new drugs (IND) or investigational device exemptions (IDE).
Obtain Institutional Review Board (IRB) Approval: IRBs play a crucial role in ensuring the protection of human subjects in research. Before initiating a clinical trial, obtain IRB approval by submitting a detailed study protocol, informed consent documents, and other required materials. IRBs review the study's scientific merit, ethical considerations, and compliance with regulations.
Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application: If your clinical research involves the use of investigational drugs or devices, you may need to submit an IND or IDE application to the FDA. These applications provide detailed information on the investigational product, its safety, efficacy, manufacturing processes, and proposed study design.
Good Clinical Practice (GCP) Guidelines: GCP guidelines provide a framework for the conduct of clinical research to ensure data integrity and participant protection. Adhere to GCP principles, including informed consent, protocol adherence, accurate documentation, and appropriate monitoring and reporting of adverse events.
Adverse Event Reporting: Monitor and report adverse events occurring during the study promptly. Follow the FDA's requirements for safety reporting, including expedited reporting of serious and unexpected adverse events. Maintain accurate and complete records of adverse events and their follow-up actions.
Data Integrity and Documentation: Ensure the integrity, accuracy, and traceability of study data. Implement robust data management practices, including proper documentation, source data verification, and secure storage of study documents. Follow regulatory requirements for data retention, including archiving study records for the required period.
Audits and Inspections: Be prepared for audits and inspections by regulatory agencies. Maintain organized and easily accessible study documentation, including study protocols, informed consent forms, case report forms, and correspondence with IRBs and regulatory agencies. Cooperate with auditors or inspectors and address any identified deficiencies or findings promptly.
ICH Guidelines
This document provides an overview of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It discusses ICH's mission to achieve greater harmonization in drug development and registration. The document then lists and briefly describes the various ICH guidelines related to quality, safety, efficacy, and multidisciplinary topics.
Clinical research management slide
This presentation discusses various topics related to clinical research management including:
- Preparation of clinical studies according to ICH guidelines.
- The difference between audits and inspections, who conducts them, and what they audit.
- Monitoring clinical studies to ensure adherence to protocols, SOPs, and regulations.
- Pharmacovigilance including adverse event reporting procedures.
- Documentation requirements for clinical research.
- Budgeting considerations for clinical trials including personnel, technology, data management.
- Vendor management activities like contracting, governance, and relationship management.
The Clinical Trials Business
New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period.
Clinical Trials Summit 2015
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
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Quality, Risk & Compliance: Risk Management for Sponsors, Site, and CROs
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Laboratory Activ Participant To Clinical Trials [Tryb ZgodnośCi]
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Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...
More from Dr Gangaprasad Waghmare
Nasal polyp
This document defines and describes nasal polyps and two main types - ethmoid and antrochoanal polyps. Ethmoid polyps arise from the ethmoid sinuses and appear as grape-like structures visible on anterior rhinoscopy. Antrochoanal polyps originate in the maxillary sinus and may extend through the nasal cavity and choana. Both cause nasal obstruction and other symptoms. Diagnosis involves nasal endoscopy, imaging, and biopsy. Treatment options include medical management, functional endoscopic sinus surgery, steroids, and polypectomy.
Diseases of external ear
This document discusses diseases that can affect the external ear. It begins by describing the anatomy of the external ear. It then discusses various congenital and traumatic conditions that can affect the pinna, including bat ear, preauricular appendages, and haematoma of the auricle. It also covers inflammatory conditions of the pinna like perichondritis. The document further discusses diseases of the external auditory canal, including conditions like otitis externa, otomycosis, and impacted cerumen. Foreign bodies in the ear are also mentioned. Finally, various diseases of the tympanic membrane are briefly outlined.
Anatomy of pharynx
The pharynx is a 12 cm fibromuscular tube that connects the nasal and oral cavities to the esophagus and larynx. It is divided into 3 parts - the nasopharynx, oropharynx, and laryngopharynx. The nasopharynx is located behind the nose and soft palate and contains the adenoids and auditory tubes. The oropharynx is located below the nasopharynx and contains the palatine tonsils. The laryngopharynx is the lowest part of the pharynx located behind the larynx. The pharynx has 5 layers and contains constrictor muscles and is innervated by cranial nerves including
GJO.MS.ID.555594
This study compared the efficacy of shadbindu taila nasya and topical Azelastine hydrochloride nasal spray in treating allergic rhinitis. Sixty patients were divided into two groups - one treated with shadbindu taila nasya and the other with Azelastine nasal spray. Symptoms were measured before and after treatment and between the groups. Results showed that shadbindu taila nasya was more effective at reducing dryness, crusting, and blocking of the nose compared to Azelastine spray. Both treatments significantly reduced symptoms except for anosmia, but shadbindu taila nasya performed better for selected symptoms. The study concluded that
ANATOMY OF NOSE
The nose has an external triangular pyramid shape directed downward with two nostrils separated by a septum. Internally, the nasal cavity is lined by ciliated epithelium and contains three turbinates and paranasal sinuses. The nasal septum separates the two nasal cavities and has attachments to the maxilla, frontal bone, and perpendicular plate of the ethmoid. Arterial blood supply comes from the maxillary and sphenopalatine arteries while nerve supply is from the trigeminal and vidian nerves. The paranasal sinuses include the maxillary, frontal, ethmoid, and sphenoid sinuses.
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This document summarizes a research study that compared the efficacy of Shadbindu taila Nasya and Azelastine hydrochloride nasal spray in treating allergic rhinitis. 60 subjects with allergic rhinitis were divided into two groups. Group A received Shadbindu taila Nasya treatment while Group B received Azelastine hydrochloride nasal spray treatment, both for 21 days. Results showed that Shadbindu taila Nasya was more effective at reducing symptoms of dryness, crusting, and blocking of the nose compared to the nasal spray. Both treatments significantly reduced symptoms, but Shadbindu taila Nasya appeared to have longer-lasting relief of
14-ORAL CAVITY
The document summarizes the anatomy of the oral cavity and related structures. It describes the different regions including the vestibule, oral cavity proper, tongue, hard and soft palate. It discusses the muscles, nerves, blood supply and common conditions related to these structures. The key areas covered are the divisions of the oral cavity, structures that form its boundaries, intrinsic and extrinsic muscles of the tongue, nerves and blood vessels innervating the oral structures.
Chronic Suppurative Otitis Media
Chronic Suppurative Otitis Media (CSOM) is a chronic inflammation of the middle ear that causes irreversible changes like perforation of the eardrum. It can cause deafness and is more common in low socioeconomic populations. CSOM is caused by past middle ear infections from diseases like measles or influenza. It exists in two types - tubo tympanic, which involves the lower middle ear, and attico antral, which affects the upper middle ear and mastoid bone. Treatment involves managing any infections, regular cleaning of the ear, antibiotic ear drops, surgery to repair the eardrum or remove cholesteatoma growths or polyps.
MYRINGOTOMY,
The document discusses various ear procedures including myringotomy, mastoidectomy, and tympanoplasty. Myringotomy involves incising the tympanic membrane to drain fluid from the middle ear, often used to treat acute otitis media. Mastoidectomy clears disease from the middle ear, epitympanum, and mastoid bone, creating a single cavity for drainage. Tympanoplasty aims to reconstruct the hearing mechanism after clearing chronic ear disease, and there are five types involving repair or reconstruction of different parts of the ear.
OTITIS MEDIA
This document discusses otitis media, including both non-suppurative and suppurative types. Non-suppurative otitis media, also known as secretory otitis media, involves accumulation of non-purulent fluid in the middle ear due to eustachian tube dysfunction. Symptoms include deafness, earache, and fluid in the ear. Treatment focuses on maintaining ear aeration through nasal decongestants and myringotomy if needed. Suppurative otitis media can be acute or chronic and involves infection and pus in the middle ear, often following upper respiratory infections. Symptoms, treatment with antibiotics, and potential complications are described.
tongue
The tongue is made of skeletal muscle and is responsible for manipulating food during chewing and swallowing. It contains four types of papillae that have taste buds and is innervated by the hypoglossal nerve which controls the extrinsic muscles. The tongue's blood supply comes from the lingual artery and its sensory innervation includes the lingual, facial, and glossopharyngeal nerves.
RHINITIS
Rhinitis is an inflammatory condition of the nasal mucosa characterized by nasal obstruction, hyperirritability, and hypersecretion. There are several types including allergic, non-allergic, infectious, and miscellaneous. Non-allergic rhinitis includes conditions like vasomotor rhinitis, rhinitis medicamentosa, occupational rhinitis, and rhinitis during pregnancy. Treatment depends on the type but may include avoidance of irritants, saline irrigation, topical steroids, decongestants, surgery, or a combination.
Anatomy of tooth
There are two sets of teeth - primary (deciduous) and secondary (permanent). A tooth consists of three parts - the anatomic crown, root, and pulp chamber. Teeth are made up of four main tissues - enamel, dentin, cementum, and dental pulp. The oral cavity environment can lead to demineralization of teeth if the pH drops too low, but remineralization can occur when the pH returns to neutral levels, aided by minerals in saliva. Proper dental anatomy and physiology knowledge is important for understanding oral health.
Management_of_Epistaxis_Goal_is_Control
Epistaxis, or nosebleeds, can be caused by local damage to the nasal mucosa or underlying systemic issues. The goal in managing epistaxis is to control the bleeding. Treatment depends on whether the bleeding is anterior or posterior, with anterior bleeds usually responding to local pressure and cauterization and posterior bleeds often requiring balloon packs or other internal packs. Prolonged packing may be needed and complications include necrosis, so careful monitoring is important. Refractory cases may require interventions like embolization. Preventive measures focus on nasal moisture and avoiding further trauma.
Epistaxis
This document discusses epistaxis (nosebleeds), including causes, examination, and treatment. It notes that epistaxis is common but rarely life-threatening. The nasal blood supply and local/systemic causes of epistaxis are outlined. Treatment depends on the location and severity, ranging from direct pressure to nasal packing or radiologic embolization. Proper examination, identification of bleeding sources, and follow-up care are emphasized.
New drug development
The document provides an overview of the new drug development process, outlining the key steps from discovery and preclinical testing to clinical trials and regulatory approval. It begins with identifying a target and potential drug candidates, then progresses through preclinical screening and safety testing, IND submission, and formal clinical trials in three phases with increasing numbers of participants. The goal is to demonstrate a drug's safety, efficacy, and appropriate dosage before seeking final regulatory review and approval to market the new drug. The entire process from discovery to approval typically takes 10-12 years and costs over $250 million.
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Clinical Research
- 1. CLINICAL RESEARCH DR G A WAGHMARE
- 2. Clinical research Clinical Research / Clinical Trials is a systematic study for new drugs in human subjects. 2
- 3. It generates data for discovering and verifying the Clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and adverse effects with the objective of determining safety and efficacy of the new drug. What is Clinical Research?
- 4. CLINICAL RESEARCH THE CAREER OF THE FUTURE
- 5. Career Prospects in Clinical Research Career prospects CRA Clinical Trials Auditor Data Manager Clinical Research Investigator Drug safety Associate Regulatory Affairs Manager Medical Writer Study Coordinator
- 6. Careers in Clinical Research Industry Clinical Research Associate Clinical Research Coordinator Clinical Research Investigator Medical Advisor Biostatistician Data Manager Clinical Trial auditor Patent Officer Medical writer Clinical Research Trainer
- 7. Domains in Clinical Research: Clinical trial Processes/ Operations Clinical Data Management Medical Writing Pharmacovigilance Regulatory Quality Assurance Business Development
- 8. Clinical Trial Processes/ Operations
- 9. Clinical Trial Processes/ Operations Phase I - (Human/clinical pharmacology trials) Phase II - (Exploratory Trials ) Phase III - (Confirmatory trials ) Phase IV - (Post marketing surveillance )
- 10. Data Management & Statistics in Clinical Research
- 11. CDM - Overview
- 12. CLINICAL DATA MANAGEMENT (CDM) CDM is the process of ensuring that data collected during the course of a clinical trial is: Accurate Complete Logical Consistent 12 12
- 13. Careers in Clinical Data Management Data Entry Field - different levels Validation Field Discrepancy Management Coding Safety reporting
- 14. Medical Writing
- 15. Medical Writing If you have….. A flair for writing Medical writing Research related writing Medico-marketing related A marketing inclination Medico-marketing in the pharma industry Technological inclination Medico-technical opportunities
- 16. Medical writers Medical communication agencies Pharma. companies Clinical research organizations Scientific press Advertising agencies Freelancers
- 17. Medical writers have different backgrounds Science Graduates PhD Pharmacy Medicine 17
- 18. Other Career Opportunities Pharmacovigilance Regulatory Quality Assurance Business Development
- 19. Careers in Pharmacovigilance Drug safety Coordinator Drug safety Associate Drug safety Manager Medical Advisor
- 20. Regulatory Indian Regulatory Ministry Of Health & Family Welfare Drugs Controller General of India (DCGI) CDSCO (Central Drugs Standard Control Organization) Schedule Y of Drug and Cosmetic Act 1940 United States Food and Drug Administration (USFDA) EMEA 20
- 21. Quality Assurance and Quality Audit Quality: the total set of characteristics of a product or service that affect its ability to satisfy a customer's stated or implied needs Quality system: the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management 21