SlideShare a Scribd company logo
1 of 28
Download to read offline
CLINICAL
RESEARCH AND
CAREER
OPPORTUNITIES
CLINICAL RESEARCH - AN OVERVIEW
 What is Clinical Research?
• Is an organized research conducted on human
beings
• Intended to provide adequate information on the use
of drugs as a therapeutic agent, with regard to
_ Usefulness
_ Safety
_ Adverse effects
CLINICAL RESEARCH

-- To Test its
- Safety
- Efficacy
- Toxicity Before Manufacturing And Markeing
RESEARCH
DRUGS BIOLOGICS
MED.
DEVICES
THE PHARMACEUTICAL ENTERPRISE
NEW DRUG DEVELOPMENT IS…
TYPES OF CLINICAL RESEARCH
Treatment research
Prevention research
Diagnostic research
Screening research
Quality of life research
Genetic studies
Epidemiological studies
REGULATIONS & GUIDELINES
 Drugs and cosmetic act
Schedule Y
 Indian GCP guidelines
 Clinical Trial Permission
 Import License
 BA BE Guidelines
 ICMR Guidelines for Medical Ethics
 ICH GCP Guidelines
 USFDA
 EU Directives
CLINICAL RESEARCH –
EARLIER(LATE 1990)
 Clinical research is a relatively new business
and profession in INDIA
 During the previous decade, not even a single
contract research organization (C.R.O) existed
in india.
 Pharmaceutical companies who were doing
clinical trials managed regulatory work on their
own and used to run the trial on their shoulders.
 Only a handful of senior doctors represented
participating in global multi-centric study
MARKET SCENARIO-WORLDWIDE
 Internationally, the demand for clinical research
specialists is even stronger than in india. The
shortage globally traverses all continents
including most notably North America, Europe,
as well as Asia, Most EU, Canadian, and US
employers are outsourcing the majority of the
clinical research work to india.
 These employers from the US, EU and Canada,
though, have thousands of jobs available
across India, which has become one of the
world’s leading centers for clinical research.
ADVANTAGE - INDIA
 Large and diverse patient pool
 Availability of Medical, Pharmacy / Science
graduates
 Highly developed IT Industry
 English speaking Medical / Research
professionals
 Higher prevalence of diseases
 Comparative cost advantages
 Changes in patent law w.e.f April 2005
( product based patency V/S procedures based
patency)
CLINICAL TRIAL APPROVALS AS PER CDSCO
DEMAND SUPPLY GAP IN INDIA
0 1 2 3 4 5
SPONSOR STAFF
CRO STAFF
INVESTIGATOR
OTHER SITE STAFF
Column1
DEMAND
SUPPLY
WHO ARE INVOLVED IN THE PROCESS OF
CLINICAL RESEARCH?
• Pharmaceutical companies
• CRO
• Drugs
• Patients/ Volunteers
• Doctors
• Clinical Research Mangers
• DCGI
• IEC
• Hospital
• Accredited Laboratories
• Regulatory Affairs
Managers
• Data Managers
• Medical Writers
 Sponsors of the trial
 Implements of trial
 Objects of the trial
 Subjects of the trial
 Investigators in the trial
 Manage the trial
 Regulatory Authority of the trial
 Monitors compliance of ethics
 Site of the trial
 Lab Investigation of the trial
 Ensure Compliance of regulatory
Guidelines
 Develops Statistics Models &
Methodology for clinical studies
 Develops the study documents,
reports & publications
CR CAREER PATHWAY
 Pharmaceutical companies
 Clinical CROs ( Contract Research Organizations)
 BA/BE Centers
 SMOs (Site Management Organizations)
 Data Management CROs
 IT Companies in Healthcare / Clinical Domain
 EDC Service providers
 Central Laboratories
 Packaging & Labeling & Contract Manufactures
 Investigator & Site Staff
 Training Centers.
BASIC QUALIFICATION REQUIRED TO ENTER
THE CR INDUSTRY
CLINICAL RESEARCH
MANAGEMENT
MSc Biochemistry
Btech Biotechnology
MSc Microbiology
MSc Zoology
PHARMACOVIGILANCE
BSc Nursing, MSc Nursing
Doctors ( MBBS, BDS, BAMS,
BVMS)
B Pharm, M Pharm
CLINICAL DATA MANAGEMENT/
BIOSTATICS
MCA, B Tech Computer
Science
MSc Computer Science, MSc
Bioinformatics
MSc Mathematics, MSc
Statistics
MSc Biostatistics
CAREER IN CROS / PHARMA / BIOTECH
COMPANIES
 Clinical Trial Assisstant (CTA)
 Clinical Research Associate (CRA)
 Senior CRA
 Clinical Team Leader
 Project Manager
 Senior Project Manager
 Manager Medical & Regulatory
 Manager-Safety / patents
 Manager Quality Assurance
 Medical Director
 Associate Director- Clinical
 Associate Director- Projects
 Director –Business Development
 Director / Head (clinical operations)
 General Manager / CEO / President
Phase 1 / 2 / 3 / 4 Trial
Project Management
Drug Development
Planning
Monitoring
Source Data Verification
Safety Reporting
Regulatory Approval
QA Audits
Business Development
CAREER IN SMO
 Clinical Research Coordinators (CRC) / Study
Coordinators
 Principal Investigators / Co-Investigators
 Medical Monitors
 Project Manager / Senior Project Manager
 Manager Medical & Regulatory
 Manager Quality Assurance
 Manager –Business Development
 Medical Director
 Associate Director _ Clinical
 Associate Director _ projects
 Director / Head ( Clinical Operations)
 General Manager / CEO / president
CAREER OPPORTUNITIES IN DM
 Data Entry operator
 Data Validation Executive
 QA Executive
 Data Manager
 Statistical Programmer
 Statistician
 Data Reviewer
 Data Base Designer
 Medical Writer
 Head –Data Management
OPPORTUNITIES FOR CR PROFESSIONALS
 Tremendous career
opportunities in the industry
 Lucrative salaries
 Excellent growth prospects
 International exposure and
prospects
KEY ORGANIZATION INTO THIS AREA
 Companies into clinical research sponsor companies :
johnson & johnson, Bicon, Glaxosmithkline Beecham,
Allergan, Astra Zeneca, Ranbaxy Laboratories, Nicholas
piramal, Dr. Reddys Laboratories, Novo Nordisk, Pflizer etc.
 CROs : Quintilies, Manipal Acunova, ICON International,
Clintec, Clinigene Internation, Accentureal, Paraxel, Asian
clinical trials, Paragon, etc
 Hospitals : st.johns Hospital, MS Ramiah Memorial Hospital,
Kidwai Hospital, Workhard Hospital, Apollo Hospitals etc.
KEY CITIES IN INDIA FOR CLINICAL
RESEARCH
• Delhi & NCR Region
• Mumbai
• Pune
• Ahmedabad
• Vadodara
• Hyderbad
• Bangalore
• Chennai
 There are some new cities like Chandigarh; Bhopal,
Indore, Coimbatore; Vizag are emerging as new
centers for clinical trials
KNOWLEDGE
Basic Knowledge
 Drugs Development Process
 Clinical Trial Design & Statistics
 Adverse Events & Toxicology
 Regulatory & Ethics (GCP, GMP, GLP)
 Pharmacy, Pharmacokinetics, Pharamacology
 Disease, Diagnosis, Drugs
 Information Technology, Computing Skills
ROLE OF TRAINING
 Every player in clinical research is expected to be
a responsible and commited manager.
 Training in clinical research to a great extent
helps to build up most of these qualities and
developed an insight into the field.
 However, it always depends upon the quality and
the methodology of training and trainers’
experience in the field.
ROLE OF TRAINING(CONT…)
 A good training will ensure that at the end of the
course the student is able to take up responsibilites
in the industry without further training by the
employer where he would be eventually placed.
 Hence it is not sufficient to have an ambition to do a
course clinical research but also to choose the right
institution.
Cr and opportunities by bhumika

More Related Content

What's hot

Clinical Research, A Basic Understanding...........
Clinical Research, A Basic Understanding...........Clinical Research, A Basic Understanding...........
Clinical Research, A Basic Understanding...........Jobin Kunjumon Vilapurathuu
 
Clinical trials: Terminology
Clinical trials: TerminologyClinical trials: Terminology
Clinical trials: TerminologyPradeep H
 
Introduction to Clinical Research Regulations
Introduction to Clinical Research RegulationsIntroduction to Clinical Research Regulations
Introduction to Clinical Research RegulationsClinosolIndia
 
Challenges and Opportunities Around Integration of Clinical Trials Data
Challenges and Opportunities Around Integration of Clinical Trials DataChallenges and Opportunities Around Integration of Clinical Trials Data
Challenges and Opportunities Around Integration of Clinical Trials DataCitiusTech
 
Medical Device Exemption and Post Marketing Survelliance
Medical Device Exemption and Post Marketing SurvellianceMedical Device Exemption and Post Marketing Survelliance
Medical Device Exemption and Post Marketing SurvellianceCSIR-URDIP, NCL Campus, Pune
 
Regulation in clinical trial, Schedule Y and recent amendments
Regulation in clinical trial, Schedule Y and recent amendmentsRegulation in clinical trial, Schedule Y and recent amendments
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
 
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
 
Regulatory affairs and Intellectual Property Rights
Regulatory affairs and Intellectual Property RightsRegulatory affairs and Intellectual Property Rights
Regulatory affairs and Intellectual Property Rightssantoshnarla
 
Regulatory guidance and guidelines for filing and approval for biologics
Regulatory guidance and guidelines for filing and approval for biologicsRegulatory guidance and guidelines for filing and approval for biologics
Regulatory guidance and guidelines for filing and approval for biologicsNimmiRoy
 
Historical aspects of drug approval process
Historical aspects of drug approval processHistorical aspects of drug approval process
Historical aspects of drug approval processparesh bharodiya
 
Regulatory aspects of Biologics in India
Regulatory aspects of Biologics in India Regulatory aspects of Biologics in India
Regulatory aspects of Biologics in India RichaTrivedi16
 
International Medical Device Regulators Forum
International Medical Device Regulators ForumInternational Medical Device Regulators Forum
International Medical Device Regulators ForumSanthiNori1
 
Clinical Research Jobs and Career Prospects
Clinical Research Jobs and Career ProspectsClinical Research Jobs and Career Prospects
Clinical Research Jobs and Career Prospectswww.CLINIINDIA.com .
 
Qa and Qc in clinical research sem ll (1)
Qa and Qc in clinical research sem ll (1)Qa and Qc in clinical research sem ll (1)
Qa and Qc in clinical research sem ll (1)Avani Pansuriya
 

What's hot (20)

Clinical Research, A Basic Understanding...........
Clinical Research, A Basic Understanding...........Clinical Research, A Basic Understanding...........
Clinical Research, A Basic Understanding...........
 
Clinical trials: Terminology
Clinical trials: TerminologyClinical trials: Terminology
Clinical trials: Terminology
 
Introduction to Clinical Research Regulations
Introduction to Clinical Research RegulationsIntroduction to Clinical Research Regulations
Introduction to Clinical Research Regulations
 
Challenges and Opportunities Around Integration of Clinical Trials Data
Challenges and Opportunities Around Integration of Clinical Trials DataChallenges and Opportunities Around Integration of Clinical Trials Data
Challenges and Opportunities Around Integration of Clinical Trials Data
 
ICH-GCP E6 R2 ALCOA+C Principles
ICH-GCP E6 R2 ALCOA+C PrinciplesICH-GCP E6 R2 ALCOA+C Principles
ICH-GCP E6 R2 ALCOA+C Principles
 
Medical Device Exemption and Post Marketing Survelliance
Medical Device Exemption and Post Marketing SurvellianceMedical Device Exemption and Post Marketing Survelliance
Medical Device Exemption and Post Marketing Survelliance
 
Regulation in clinical trial, Schedule Y and recent amendments
Regulation in clinical trial, Schedule Y and recent amendmentsRegulation in clinical trial, Schedule Y and recent amendments
Regulation in clinical trial, Schedule Y and recent amendments
 
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
 
Regulatory affairs and Intellectual Property Rights
Regulatory affairs and Intellectual Property RightsRegulatory affairs and Intellectual Property Rights
Regulatory affairs and Intellectual Property Rights
 
Regulatory guidance and guidelines for filing and approval for biologics
Regulatory guidance and guidelines for filing and approval for biologicsRegulatory guidance and guidelines for filing and approval for biologics
Regulatory guidance and guidelines for filing and approval for biologics
 
Historical aspects of drug approval process
Historical aspects of drug approval processHistorical aspects of drug approval process
Historical aspects of drug approval process
 
Ich e6(r1)
Ich e6(r1)Ich e6(r1)
Ich e6(r1)
 
Medical devices CHINA
Medical devices CHINA Medical devices CHINA
Medical devices CHINA
 
Clinical trial process
Clinical trial processClinical trial process
Clinical trial process
 
Clinical Research
Clinical ResearchClinical Research
Clinical Research
 
Regulatory aspects of Biologics in India
Regulatory aspects of Biologics in India Regulatory aspects of Biologics in India
Regulatory aspects of Biologics in India
 
International Medical Device Regulators Forum
International Medical Device Regulators ForumInternational Medical Device Regulators Forum
International Medical Device Regulators Forum
 
Drug Regulatory affairs
Drug Regulatory affairsDrug Regulatory affairs
Drug Regulatory affairs
 
Clinical Research Jobs and Career Prospects
Clinical Research Jobs and Career ProspectsClinical Research Jobs and Career Prospects
Clinical Research Jobs and Career Prospects
 
Qa and Qc in clinical research sem ll (1)
Qa and Qc in clinical research sem ll (1)Qa and Qc in clinical research sem ll (1)
Qa and Qc in clinical research sem ll (1)
 

Similar to Cr and opportunities by bhumika

Clinical Research Presentation
Clinical Research PresentationClinical Research Presentation
Clinical Research Presentationdeepikashankar
 
Clinical Trials in India
Clinical Trials in IndiaClinical Trials in India
Clinical Trials in Indiavaatsalya
 
Clinical Research Training with Job Placement
Clinical Research Training with Job PlacementClinical Research Training with Job Placement
Clinical Research Training with Job Placementcrtraining
 
Vedic Lifesciences Pvt Ltd
Vedic Lifesciences Pvt LtdVedic Lifesciences Pvt Ltd
Vedic Lifesciences Pvt Ltdexoticnaturals
 
Pharmaceutical Quality - The Office of
Pharmaceutical Quality -  The Office ofPharmaceutical Quality -  The Office of
Pharmaceutical Quality - The Office ofAjaz Hussain
 
Presentation China And Usa July 2011
Presentation   China And Usa July 2011Presentation   China And Usa July 2011
Presentation China And Usa July 2011roeandjoe
 
Drug Information Agency (dia) 7th annual conference: Kapil Khandelwal, www.ka...
Drug Information Agency (dia) 7th annual conference: Kapil Khandelwal, www.ka...Drug Information Agency (dia) 7th annual conference: Kapil Khandelwal, www.ka...
Drug Information Agency (dia) 7th annual conference: Kapil Khandelwal, www.ka...Kapil Khandelwal (KK)
 
CRSIC Seminar Brochure 15 October 2016
CRSIC Seminar Brochure 15 October 2016CRSIC Seminar Brochure 15 October 2016
CRSIC Seminar Brochure 15 October 2016Anisha Pargal
 
CRSIC Seminar Brochure 15 october 2016, Mumbai
CRSIC Seminar Brochure 15 october 2016, MumbaiCRSIC Seminar Brochure 15 october 2016, Mumbai
CRSIC Seminar Brochure 15 october 2016, MumbaiAnisha Pargal
 
Good Clinical Practice and Pharmacovigilance
Good Clinical Practice and PharmacovigilanceGood Clinical Practice and Pharmacovigilance
Good Clinical Practice and PharmacovigilanceMd. Zakaria Faruki
 
KPSCS CORPORATE PRESENTATION
KPSCS CORPORATE PRESENTATIONKPSCS CORPORATE PRESENTATION
KPSCS CORPORATE PRESENTATIONAnkit Tyagi
 
Anthony Presentation DIA Florida Ctd Nov2007
Anthony Presentation DIA Florida Ctd Nov2007Anthony Presentation DIA Florida Ctd Nov2007
Anthony Presentation DIA Florida Ctd Nov2007AKTaylor
 

Similar to Cr and opportunities by bhumika (20)

Clinical Research Presentation
Clinical Research PresentationClinical Research Presentation
Clinical Research Presentation
 
Clinical Trials in India
Clinical Trials in IndiaClinical Trials in India
Clinical Trials in India
 
VAC3 Corporate Presentation
VAC3 Corporate PresentationVAC3 Corporate Presentation
VAC3 Corporate Presentation
 
Clinical Research Training with Job Placement
Clinical Research Training with Job PlacementClinical Research Training with Job Placement
Clinical Research Training with Job Placement
 
Vedic Lifesciences Pvt Ltd
Vedic Lifesciences Pvt LtdVedic Lifesciences Pvt Ltd
Vedic Lifesciences Pvt Ltd
 
Vedic Lifesciences Pvt Ltd.
Vedic Lifesciences Pvt Ltd.Vedic Lifesciences Pvt Ltd.
Vedic Lifesciences Pvt Ltd.
 
Pharmaceutical Quality - The Office of
Pharmaceutical Quality -  The Office ofPharmaceutical Quality -  The Office of
Pharmaceutical Quality - The Office of
 
Presentation China And Usa July 2011
Presentation   China And Usa July 2011Presentation   China And Usa July 2011
Presentation China And Usa July 2011
 
7th annual clinical trials summit 2016
7th annual clinical trials summit 20167th annual clinical trials summit 2016
7th annual clinical trials summit 2016
 
Drug Information Agency (dia) 7th annual conference: Kapil Khandelwal, www.ka...
Drug Information Agency (dia) 7th annual conference: Kapil Khandelwal, www.ka...Drug Information Agency (dia) 7th annual conference: Kapil Khandelwal, www.ka...
Drug Information Agency (dia) 7th annual conference: Kapil Khandelwal, www.ka...
 
Clinical Trials Summit 2015
Clinical Trials Summit 2015Clinical Trials Summit 2015
Clinical Trials Summit 2015
 
6th annual clinical trials summit 2015
6th annual clinical trials summit 20156th annual clinical trials summit 2015
6th annual clinical trials summit 2015
 
Careers In Clinical Research
Careers In Clinical ResearchCareers In Clinical Research
Careers In Clinical Research
 
CRSIC Seminar Brochure 15 October 2016
CRSIC Seminar Brochure 15 October 2016CRSIC Seminar Brochure 15 October 2016
CRSIC Seminar Brochure 15 October 2016
 
CRSIC Seminar Brochure 15 october 2016, Mumbai
CRSIC Seminar Brochure 15 october 2016, MumbaiCRSIC Seminar Brochure 15 october 2016, Mumbai
CRSIC Seminar Brochure 15 october 2016, Mumbai
 
Good Clinical Practice and Pharmacovigilance
Good Clinical Practice and PharmacovigilanceGood Clinical Practice and Pharmacovigilance
Good Clinical Practice and Pharmacovigilance
 
legal cv
legal cvlegal cv
legal cv
 
Gcp
GcpGcp
Gcp
 
KPSCS CORPORATE PRESENTATION
KPSCS CORPORATE PRESENTATIONKPSCS CORPORATE PRESENTATION
KPSCS CORPORATE PRESENTATION
 
Anthony Presentation DIA Florida Ctd Nov2007
Anthony Presentation DIA Florida Ctd Nov2007Anthony Presentation DIA Florida Ctd Nov2007
Anthony Presentation DIA Florida Ctd Nov2007
 

Recently uploaded

ANEMIA IN PREGNANCY by Dr. Akebom Kidanemariam
ANEMIA IN PREGNANCY by Dr. Akebom KidanemariamANEMIA IN PREGNANCY by Dr. Akebom Kidanemariam
ANEMIA IN PREGNANCY by Dr. Akebom KidanemariamAkebom Gebremichael
 
COVID-19 (NOVEL CORONA VIRUS DISEASE PANDEMIC ).pptx
COVID-19  (NOVEL CORONA  VIRUS DISEASE PANDEMIC ).pptxCOVID-19  (NOVEL CORONA  VIRUS DISEASE PANDEMIC ).pptx
COVID-19 (NOVEL CORONA VIRUS DISEASE PANDEMIC ).pptxBibekananda shah
 
Systemic Lupus Erythematosus -SLE PT2.ppt
Systemic  Lupus  Erythematosus -SLE PT2.pptSystemic  Lupus  Erythematosus -SLE PT2.ppt
Systemic Lupus Erythematosus -SLE PT2.pptraviapr7
 
PHYSIOTHERAPY IN HEART TRANSPLANTATION..
PHYSIOTHERAPY IN HEART TRANSPLANTATION..PHYSIOTHERAPY IN HEART TRANSPLANTATION..
PHYSIOTHERAPY IN HEART TRANSPLANTATION..AneriPatwari
 
Measurement of Radiation and Dosimetric Procedure.pptx
Measurement of Radiation and Dosimetric Procedure.pptxMeasurement of Radiation and Dosimetric Procedure.pptx
Measurement of Radiation and Dosimetric Procedure.pptxDr. Dheeraj Kumar
 
Chronic-Fatigue-Syndrome-CFS-Understanding-a-Complex-Disorder.pptx
Chronic-Fatigue-Syndrome-CFS-Understanding-a-Complex-Disorder.pptxChronic-Fatigue-Syndrome-CFS-Understanding-a-Complex-Disorder.pptx
Chronic-Fatigue-Syndrome-CFS-Understanding-a-Complex-Disorder.pptxSasikiranMarri
 
Giftedness: Understanding Everyday Neurobiology for Self-Knowledge
Giftedness: Understanding Everyday Neurobiology for Self-KnowledgeGiftedness: Understanding Everyday Neurobiology for Self-Knowledge
Giftedness: Understanding Everyday Neurobiology for Self-Knowledgeassessoriafabianodea
 
Study on the Impact of FOCUS-PDCA Management Model on the Disinfection Qualit...
Study on the Impact of FOCUS-PDCA Management Model on the Disinfection Qualit...Study on the Impact of FOCUS-PDCA Management Model on the Disinfection Qualit...
Study on the Impact of FOCUS-PDCA Management Model on the Disinfection Qualit...MehranMouzam
 
VarSeq 2.6.0: Advancing Pharmacogenomics and Genomic Analysis
VarSeq 2.6.0: Advancing Pharmacogenomics and Genomic AnalysisVarSeq 2.6.0: Advancing Pharmacogenomics and Genomic Analysis
VarSeq 2.6.0: Advancing Pharmacogenomics and Genomic AnalysisGolden Helix
 
History and Development of Pharmacovigilence.pdf
History and Development of Pharmacovigilence.pdfHistory and Development of Pharmacovigilence.pdf
History and Development of Pharmacovigilence.pdfSasikiranMarri
 
Big Data Analysis Suggests COVID Vaccination Increases Excess Mortality Of ...
Big Data Analysis Suggests COVID  Vaccination Increases Excess Mortality Of  ...Big Data Analysis Suggests COVID  Vaccination Increases Excess Mortality Of  ...
Big Data Analysis Suggests COVID Vaccination Increases Excess Mortality Of ...sdateam0
 
Nutrition of OCD for my Nutritional Neuroscience Class
Nutrition of OCD for my Nutritional Neuroscience ClassNutrition of OCD for my Nutritional Neuroscience Class
Nutrition of OCD for my Nutritional Neuroscience Classmanuelazg2001
 
Plant Fibres used as Surgical Dressings PDF.pdf
Plant Fibres used as Surgical Dressings PDF.pdfPlant Fibres used as Surgical Dressings PDF.pdf
Plant Fibres used as Surgical Dressings PDF.pdfDivya Kanojiya
 
Rheumatoid arthritis - Musculoskeletal disorders.ppt
Rheumatoid arthritis - Musculoskeletal disorders.pptRheumatoid arthritis - Musculoskeletal disorders.ppt
Rheumatoid arthritis - Musculoskeletal disorders.pptraviapr7
 
Myelin Oligodendrocyte Glycoprotein antibody associated disease (MOGAD)
Myelin Oligodendrocyte Glycoprotein antibody associated disease (MOGAD)Myelin Oligodendrocyte Glycoprotein antibody associated disease (MOGAD)
Myelin Oligodendrocyte Glycoprotein antibody associated disease (MOGAD)MohamadAlhes
 
PULMONARY EDEMA AND ITS MANAGEMENT.pdf
PULMONARY EDEMA AND  ITS  MANAGEMENT.pdfPULMONARY EDEMA AND  ITS  MANAGEMENT.pdf
PULMONARY EDEMA AND ITS MANAGEMENT.pdfDolisha Warbi
 
HERBS AS HEALTH FOOD - Brief introduction and therapeutic applications of: N...
HERBS AS HEALTH FOOD - Brief introduction and therapeutic applications of:  N...HERBS AS HEALTH FOOD - Brief introduction and therapeutic applications of:  N...
HERBS AS HEALTH FOOD - Brief introduction and therapeutic applications of: N...Divya Kanojiya
 
Valproic Acid. (VPA). Antiseizure medication
Valproic Acid.  (VPA). Antiseizure medicationValproic Acid.  (VPA). Antiseizure medication
Valproic Acid. (VPA). Antiseizure medicationMohamadAlhes
 
epilepsy and status epilepticus for undergraduate.pptx
epilepsy and status epilepticus  for undergraduate.pptxepilepsy and status epilepticus  for undergraduate.pptx
epilepsy and status epilepticus for undergraduate.pptxMohamed Rizk Khodair
 
Primary headache and facial pain. (2024)
Primary headache and facial pain. (2024)Primary headache and facial pain. (2024)
Primary headache and facial pain. (2024)Mohamed Rizk Khodair
 

Recently uploaded (20)

ANEMIA IN PREGNANCY by Dr. Akebom Kidanemariam
ANEMIA IN PREGNANCY by Dr. Akebom KidanemariamANEMIA IN PREGNANCY by Dr. Akebom Kidanemariam
ANEMIA IN PREGNANCY by Dr. Akebom Kidanemariam
 
COVID-19 (NOVEL CORONA VIRUS DISEASE PANDEMIC ).pptx
COVID-19  (NOVEL CORONA  VIRUS DISEASE PANDEMIC ).pptxCOVID-19  (NOVEL CORONA  VIRUS DISEASE PANDEMIC ).pptx
COVID-19 (NOVEL CORONA VIRUS DISEASE PANDEMIC ).pptx
 
Systemic Lupus Erythematosus -SLE PT2.ppt
Systemic  Lupus  Erythematosus -SLE PT2.pptSystemic  Lupus  Erythematosus -SLE PT2.ppt
Systemic Lupus Erythematosus -SLE PT2.ppt
 
PHYSIOTHERAPY IN HEART TRANSPLANTATION..
PHYSIOTHERAPY IN HEART TRANSPLANTATION..PHYSIOTHERAPY IN HEART TRANSPLANTATION..
PHYSIOTHERAPY IN HEART TRANSPLANTATION..
 
Measurement of Radiation and Dosimetric Procedure.pptx
Measurement of Radiation and Dosimetric Procedure.pptxMeasurement of Radiation and Dosimetric Procedure.pptx
Measurement of Radiation and Dosimetric Procedure.pptx
 
Chronic-Fatigue-Syndrome-CFS-Understanding-a-Complex-Disorder.pptx
Chronic-Fatigue-Syndrome-CFS-Understanding-a-Complex-Disorder.pptxChronic-Fatigue-Syndrome-CFS-Understanding-a-Complex-Disorder.pptx
Chronic-Fatigue-Syndrome-CFS-Understanding-a-Complex-Disorder.pptx
 
Giftedness: Understanding Everyday Neurobiology for Self-Knowledge
Giftedness: Understanding Everyday Neurobiology for Self-KnowledgeGiftedness: Understanding Everyday Neurobiology for Self-Knowledge
Giftedness: Understanding Everyday Neurobiology for Self-Knowledge
 
Study on the Impact of FOCUS-PDCA Management Model on the Disinfection Qualit...
Study on the Impact of FOCUS-PDCA Management Model on the Disinfection Qualit...Study on the Impact of FOCUS-PDCA Management Model on the Disinfection Qualit...
Study on the Impact of FOCUS-PDCA Management Model on the Disinfection Qualit...
 
VarSeq 2.6.0: Advancing Pharmacogenomics and Genomic Analysis
VarSeq 2.6.0: Advancing Pharmacogenomics and Genomic AnalysisVarSeq 2.6.0: Advancing Pharmacogenomics and Genomic Analysis
VarSeq 2.6.0: Advancing Pharmacogenomics and Genomic Analysis
 
History and Development of Pharmacovigilence.pdf
History and Development of Pharmacovigilence.pdfHistory and Development of Pharmacovigilence.pdf
History and Development of Pharmacovigilence.pdf
 
Big Data Analysis Suggests COVID Vaccination Increases Excess Mortality Of ...
Big Data Analysis Suggests COVID  Vaccination Increases Excess Mortality Of  ...Big Data Analysis Suggests COVID  Vaccination Increases Excess Mortality Of  ...
Big Data Analysis Suggests COVID Vaccination Increases Excess Mortality Of ...
 
Nutrition of OCD for my Nutritional Neuroscience Class
Nutrition of OCD for my Nutritional Neuroscience ClassNutrition of OCD for my Nutritional Neuroscience Class
Nutrition of OCD for my Nutritional Neuroscience Class
 
Plant Fibres used as Surgical Dressings PDF.pdf
Plant Fibres used as Surgical Dressings PDF.pdfPlant Fibres used as Surgical Dressings PDF.pdf
Plant Fibres used as Surgical Dressings PDF.pdf
 
Rheumatoid arthritis - Musculoskeletal disorders.ppt
Rheumatoid arthritis - Musculoskeletal disorders.pptRheumatoid arthritis - Musculoskeletal disorders.ppt
Rheumatoid arthritis - Musculoskeletal disorders.ppt
 
Myelin Oligodendrocyte Glycoprotein antibody associated disease (MOGAD)
Myelin Oligodendrocyte Glycoprotein antibody associated disease (MOGAD)Myelin Oligodendrocyte Glycoprotein antibody associated disease (MOGAD)
Myelin Oligodendrocyte Glycoprotein antibody associated disease (MOGAD)
 
PULMONARY EDEMA AND ITS MANAGEMENT.pdf
PULMONARY EDEMA AND  ITS  MANAGEMENT.pdfPULMONARY EDEMA AND  ITS  MANAGEMENT.pdf
PULMONARY EDEMA AND ITS MANAGEMENT.pdf
 
HERBS AS HEALTH FOOD - Brief introduction and therapeutic applications of: N...
HERBS AS HEALTH FOOD - Brief introduction and therapeutic applications of:  N...HERBS AS HEALTH FOOD - Brief introduction and therapeutic applications of:  N...
HERBS AS HEALTH FOOD - Brief introduction and therapeutic applications of: N...
 
Valproic Acid. (VPA). Antiseizure medication
Valproic Acid.  (VPA). Antiseizure medicationValproic Acid.  (VPA). Antiseizure medication
Valproic Acid. (VPA). Antiseizure medication
 
epilepsy and status epilepticus for undergraduate.pptx
epilepsy and status epilepticus  for undergraduate.pptxepilepsy and status epilepticus  for undergraduate.pptx
epilepsy and status epilepticus for undergraduate.pptx
 
Primary headache and facial pain. (2024)
Primary headache and facial pain. (2024)Primary headache and facial pain. (2024)
Primary headache and facial pain. (2024)
 

Cr and opportunities by bhumika

  • 2.
  • 3. CLINICAL RESEARCH - AN OVERVIEW  What is Clinical Research? • Is an organized research conducted on human beings • Intended to provide adequate information on the use of drugs as a therapeutic agent, with regard to _ Usefulness _ Safety _ Adverse effects
  • 4. CLINICAL RESEARCH  -- To Test its - Safety - Efficacy - Toxicity Before Manufacturing And Markeing RESEARCH DRUGS BIOLOGICS MED. DEVICES
  • 6.
  • 8. TYPES OF CLINICAL RESEARCH Treatment research Prevention research Diagnostic research Screening research Quality of life research Genetic studies Epidemiological studies
  • 9. REGULATIONS & GUIDELINES  Drugs and cosmetic act Schedule Y  Indian GCP guidelines  Clinical Trial Permission  Import License  BA BE Guidelines  ICMR Guidelines for Medical Ethics  ICH GCP Guidelines  USFDA  EU Directives
  • 10. CLINICAL RESEARCH – EARLIER(LATE 1990)  Clinical research is a relatively new business and profession in INDIA  During the previous decade, not even a single contract research organization (C.R.O) existed in india.  Pharmaceutical companies who were doing clinical trials managed regulatory work on their own and used to run the trial on their shoulders.  Only a handful of senior doctors represented participating in global multi-centric study
  • 11.
  • 12. MARKET SCENARIO-WORLDWIDE  Internationally, the demand for clinical research specialists is even stronger than in india. The shortage globally traverses all continents including most notably North America, Europe, as well as Asia, Most EU, Canadian, and US employers are outsourcing the majority of the clinical research work to india.  These employers from the US, EU and Canada, though, have thousands of jobs available across India, which has become one of the world’s leading centers for clinical research.
  • 13. ADVANTAGE - INDIA  Large and diverse patient pool  Availability of Medical, Pharmacy / Science graduates  Highly developed IT Industry  English speaking Medical / Research professionals  Higher prevalence of diseases  Comparative cost advantages  Changes in patent law w.e.f April 2005 ( product based patency V/S procedures based patency)
  • 14. CLINICAL TRIAL APPROVALS AS PER CDSCO
  • 15. DEMAND SUPPLY GAP IN INDIA 0 1 2 3 4 5 SPONSOR STAFF CRO STAFF INVESTIGATOR OTHER SITE STAFF Column1 DEMAND SUPPLY
  • 16. WHO ARE INVOLVED IN THE PROCESS OF CLINICAL RESEARCH? • Pharmaceutical companies • CRO • Drugs • Patients/ Volunteers • Doctors • Clinical Research Mangers • DCGI • IEC • Hospital • Accredited Laboratories • Regulatory Affairs Managers • Data Managers • Medical Writers  Sponsors of the trial  Implements of trial  Objects of the trial  Subjects of the trial  Investigators in the trial  Manage the trial  Regulatory Authority of the trial  Monitors compliance of ethics  Site of the trial  Lab Investigation of the trial  Ensure Compliance of regulatory Guidelines  Develops Statistics Models & Methodology for clinical studies  Develops the study documents, reports & publications
  • 17. CR CAREER PATHWAY  Pharmaceutical companies  Clinical CROs ( Contract Research Organizations)  BA/BE Centers  SMOs (Site Management Organizations)  Data Management CROs  IT Companies in Healthcare / Clinical Domain  EDC Service providers  Central Laboratories  Packaging & Labeling & Contract Manufactures  Investigator & Site Staff  Training Centers.
  • 18. BASIC QUALIFICATION REQUIRED TO ENTER THE CR INDUSTRY CLINICAL RESEARCH MANAGEMENT MSc Biochemistry Btech Biotechnology MSc Microbiology MSc Zoology PHARMACOVIGILANCE BSc Nursing, MSc Nursing Doctors ( MBBS, BDS, BAMS, BVMS) B Pharm, M Pharm CLINICAL DATA MANAGEMENT/ BIOSTATICS MCA, B Tech Computer Science MSc Computer Science, MSc Bioinformatics MSc Mathematics, MSc Statistics MSc Biostatistics
  • 19. CAREER IN CROS / PHARMA / BIOTECH COMPANIES  Clinical Trial Assisstant (CTA)  Clinical Research Associate (CRA)  Senior CRA  Clinical Team Leader  Project Manager  Senior Project Manager  Manager Medical & Regulatory  Manager-Safety / patents  Manager Quality Assurance  Medical Director  Associate Director- Clinical  Associate Director- Projects  Director –Business Development  Director / Head (clinical operations)  General Manager / CEO / President Phase 1 / 2 / 3 / 4 Trial Project Management Drug Development Planning Monitoring Source Data Verification Safety Reporting Regulatory Approval QA Audits Business Development
  • 20. CAREER IN SMO  Clinical Research Coordinators (CRC) / Study Coordinators  Principal Investigators / Co-Investigators  Medical Monitors  Project Manager / Senior Project Manager  Manager Medical & Regulatory  Manager Quality Assurance  Manager –Business Development  Medical Director  Associate Director _ Clinical  Associate Director _ projects  Director / Head ( Clinical Operations)  General Manager / CEO / president
  • 21. CAREER OPPORTUNITIES IN DM  Data Entry operator  Data Validation Executive  QA Executive  Data Manager  Statistical Programmer  Statistician  Data Reviewer  Data Base Designer  Medical Writer  Head –Data Management
  • 22. OPPORTUNITIES FOR CR PROFESSIONALS  Tremendous career opportunities in the industry  Lucrative salaries  Excellent growth prospects  International exposure and prospects
  • 23. KEY ORGANIZATION INTO THIS AREA  Companies into clinical research sponsor companies : johnson & johnson, Bicon, Glaxosmithkline Beecham, Allergan, Astra Zeneca, Ranbaxy Laboratories, Nicholas piramal, Dr. Reddys Laboratories, Novo Nordisk, Pflizer etc.  CROs : Quintilies, Manipal Acunova, ICON International, Clintec, Clinigene Internation, Accentureal, Paraxel, Asian clinical trials, Paragon, etc  Hospitals : st.johns Hospital, MS Ramiah Memorial Hospital, Kidwai Hospital, Workhard Hospital, Apollo Hospitals etc.
  • 24. KEY CITIES IN INDIA FOR CLINICAL RESEARCH • Delhi & NCR Region • Mumbai • Pune • Ahmedabad • Vadodara • Hyderbad • Bangalore • Chennai  There are some new cities like Chandigarh; Bhopal, Indore, Coimbatore; Vizag are emerging as new centers for clinical trials
  • 25. KNOWLEDGE Basic Knowledge  Drugs Development Process  Clinical Trial Design & Statistics  Adverse Events & Toxicology  Regulatory & Ethics (GCP, GMP, GLP)  Pharmacy, Pharmacokinetics, Pharamacology  Disease, Diagnosis, Drugs  Information Technology, Computing Skills
  • 26. ROLE OF TRAINING  Every player in clinical research is expected to be a responsible and commited manager.  Training in clinical research to a great extent helps to build up most of these qualities and developed an insight into the field.  However, it always depends upon the quality and the methodology of training and trainers’ experience in the field.
  • 27. ROLE OF TRAINING(CONT…)  A good training will ensure that at the end of the course the student is able to take up responsibilites in the industry without further training by the employer where he would be eventually placed.  Hence it is not sufficient to have an ambition to do a course clinical research but also to choose the right institution.