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Clinical Research Presentation


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my first presentation on clinical research and its carrier opportunities

my first presentation on clinical research and its carrier opportunities

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  • 1. WELCOME
  • 2. What is clinical research? ‘ CLINICAL’ means: ‘Treatment of patients’ ‘ RESEARCH’ means: ‘Systematic investigation & study in order to establish facts & reach new conclusions’
  • 3.
    • A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions.
    • Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people and ways to improve health.
    • Clinical trials are the final step in a long research process that include preliminary laboratory research and experiment.
  • 4. Types of clinical trial
    • Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
    • Observational trials address health issues in large groups of people or populations in natural settings.
  • 5. Phases of drug development
    • Identification of new molecule
    • Screening of biological activity/experiment design
    • Preformulation
    • Formulation
    • Stability testing.
  • 6. Phases of Drug Development
    • Steps prior to human trials:
    • Preclinical (nonclinical).
        • Animal and in vitro studies.
    • A study to test a drug procedure or other medical treatment in animals. Preclinical studies are required before clinical trials can be started.
    • Investigational new drug application (IND) or Investigational device exemption (IDE) for the FDA
  • 7. Basis for phased drug development
    • Safety
    • Pharmacology
    • Efficacy
  • 8. Phases of Drug Development
    • Phase 1:
      • First studies in human.
      • Usually involve small groups of healthy volunteers or patients with particular disease – 20 - 80.
      • Short duration.
      • Provide preliminary safety and tolerability evaluation.
      • Establish pharmacokinetic and pharmacodynamic profiles of the drug
  • 9. Phases of Drug Development
      • Evaluate efficacy and short-term safety of the drug.
      • small groups of patients with disease under study.
      • 100-300 subjects
      • Have well defined eligibility criteria
      • Determine dosing
      • Duration –couple of months to 2 years
    Phase 2:
  • 10. Phases of Drug Development
    • Phase 3
      • Larger, well-controlled trials with larger groups of subjects.
      • Eligibility criteria usually broader
      • Simulate the actual treatment condition
      • Establishes safety and efficacy profile in broad sample.
      • Results used in marketing application and official product labeling.
  • 11. Phases of Drug Development
    • Phase 4:
        • Conducted after marketing approval of drug.
    • -Post marketing studies sometimes designed to differentiate the drug from competitors and demonstrate health economic benefits.
        • Include post registration usage studies and post-marketing surveillance studies.
  • 12. Key stake holders
    • Study sponsor
    • Investigator and site personnel
    • Monitors
    • IRB/IEC
    • Study subjects
    • Hospital administration
    • Regulator
  • 13. Key documents in Clinical research
    • Investigators brochure
    • Study protocol
    • Informed consent form
    • Case report form
    • Source documents
    • Clinical study report
  • 14. International Conference on Harmonisation
    • Agreement between the united states, Japan and European Union
    • Describes Good Clinical Practices
    • The main agenda of ICH-GCP is to protect human subjects and ensure credibility of data
  • 15. Why Career in Clinical Research?
    • Fastest growing segment in the healthcare / pharmaceutical industry
    • Excellent Opportunity to Develop Combination of Technical and Management Skill Development
    • Part of the Global Growth Opportunity
    • Wider Job Horizon
    • Rapidly Growing Opportunities… (internal and external)
    • Higher Salaries
    • Higher Job Satisfaction
    • Continuous Training Opportunities
    • Overseas Job Opportunities
  • 16. India –Hub of global clinical research
    • India is one of the top 3 countries where companies plan to spend the most R&D dollars over the next three years
    • Over 30 CRO’s offer phase 1 to 4 trials complying with ICH-GCP guidelines
    • Over US$500 million FDI expected in the next 18months
    • With 100 hospitals serving as sites for clinical trials ,India is emerging as one of the fastest recruiter of subjects across the world.
  • 17. Advantages of India
    • The clinical community populated with English speaking ,western –trained graduates
    • Sophisticated technological infrastructure
    • 100 million plus English speaking /trained professionals
    • Over 2 million science graduates
    • Large pool of treatment naïve patients from multiethnic and multiracial backgrounds
    • Better patient recruitment, retention and compliance
  • 18.
    • Cost effective operations
    • Participants generally benefit ,as the trials conducted in India mostly in phase 2 -4, provide improved care and cost savings as procedures and drugs are provided at no charge
    • Higher GMP/GLP/GCP compliance
    • Maximum number of approved GMP plants outside USA
    • Excellent quality management ,technology and infrastructure
    • Increasing presence of all pharma majors ,CROs and also in-house CROs set up by leading pharma companies
    • Strong IT industry availability of IT skilled manpower
  • 19. Regulatory frame work
    • Positive regulatory environment –protocols approved by DCGI/ Schedule Y
    • CDSCO (Central Drugs Standard Control Organization) to regulate Clinical research
    • Further strengthening of environment by setting up National Drug Authority
    • Intellectual property protection
        • As of January 2005 ,recognize product patents from 1995 to present
    • Clinical trial protocol time is reducing
    • Duty free import of clinical trial supplies
    • Easier drug importation procedure
    • ICMR guidelines on the safety of Human Subjects
  • 20. India’s vital clinical statistics
    • Cancer : 3 million
    • Diabetes : 34 million
    • HIV : 8-10 million
    • Epilepsy : 8 million
    • Hypertension : 150 million
    • Schizophrenia : 1 million
    • Asthma : 40 million
    • Alzheimer’s : 1.5 million
    • Cardiac related deaths : 2 million
    • Recruits for genetic studies
    • 600,000 practicing physicians
    • 14,000 hospitals
    • 700,000 beds
    • 17,000 medical graduates per year
  • 21. Indian Market For Clinical Research
    • 2002 Industry Spending on
    • CRO Services and Investigator Grants $30 million
    • Market Size in 2005-06 $200 million
    • Estimated Market Size in 2007 $450 million
    • Estimated Market Size in 2008 $600 million
    • 2012Projected Industry Spending on
    • CRO Services and Investigator Grants $2 billion
  • 22. Some Pharma Companies in Clinical Research
    • Chiron, Mumbai
    • Astra Zeneca Pharma India Ltd, Bangalore
    • Astra Zeneca Foundation, Bangalore
    • AventisPasteur, Delhi
    • Pfizer Ltd, Mumbai
    • Pfizer Biometrics, Mumbai
    • Altana(Zydus), Mumbai
    • Eli Lilly, Delhi
    • Boston Scientific, Delhi
    • Hospira, Delhi
    • Merck ,Delhi
    • Sanofi Aventis Syntho Lab, Mumbai
    • GSK, Glaxo SmithKline Pharmaceuticals Ltd,Mumbai
    • Novartis International Clinical Development Center,
    • Novartis Pharma, Mumbai
    • Roche,Mumbai
  • 23. Key CROs in India Quintiles Ahmadabad / Bangalore Synchron Ahmedabad /Bangalore Lambda Ahmedabad Siro Clinpharm Mumbai I-Gate Mumbai Reliance Clinical Services Mumbai PPD Mumbai Onmnicare Bangalore ICON Bangalore Clin Trac Bangalore PharmaNet Bangalore Pharm-Olam Bangalore Lotus Labs Bangalore Vimta Hyderabad GVK Hyderabad BioServe Clinical Research Hyderabad Apothecaries Delhi
  • 24. Types of Jobs
    • Clinical Monitors / CRAs
    • Clinical Research Coordinators / Site Coordinators
    • Drug Safety Personnel
    • Project Personnel
    • Medical Monitors
    • Regulatory Affairs Monitors
    • Medical Writers
    • Quality Control / Assurance Personnel
    • Data Management Personnel
    • Statisticians
    • Scientists
    • Lab Personnel
    • Management & Support Personnel
  • 25. Types of Employers
    • Pharmaceutical Companies
    • Contract Research Organization
    • Hospitals
    • Non Government Organization
    • WHO
  • 26. Key cities in India for clinical research
    • Delhi &NCR Region
    • Mumbai
    • Pune
    • Ahmedabad
    • Hyderabad
    • Bangalore
    • Chennai
  • 27. Challenges of current CR Industry
    • Major gap in Demand & Supply of trained manpower – An unmet need
    • By 2012 Indian market would be over US$2 billion, and would continue to grow at rapid pace.
    • Over 75 CROs & 60 In-house Pharmaceutical Clinical Research & R&D Facilities in India and increasing
    • Current trained manpower demand in the field of Clinical Research is over 10,000 trained personnel per annum.
  • 28.
    • By 2012 over 50,000 certified/trained professionals will be required.
    • The current facilities are able to train only 1,500 professionals.
    • Employers required well trained professionals.
    • very rapid growth in number and size of company
    • Lack of specialization
    • Spectrum of skills required is in scarcity
    • Limited pool of experienced people
    • Employee retention
    • Continuous training
  • 30. “ Committed to provide highest quality training ,education &management solutions and develop superior human resource for the global clinical research industry”.
  • 31. About Cliniminds
    • Cliniminds was established in the year 2004 by a group of Senior Professionals from Pharmaceutical, Clinical Research & Healthcare industry.
    • Two brands – Cliniminds & Mediminds were established to provide vocational and professional education and training in the clinical research, healthcare & pharmaceutical areas.
    • To provide opportunities to fresh graduates or working executives aspiring to build career in the booming Clinical Research / Healthcare/ Pharmaceutical industry.
    • To provide continuing education, Professional development, and vocational skills enhancement Programs for Clinical Research / Healthcare / Pharmaceutical professionals
  • 32. Features of Cliniminds
    • Cliniminds is an innovative training company providing a wide range of clinical research training solutions to the students, pharmaceutical companies, CRO s and healthcare companies in India and other part of the world
    • Cliniminds-Academy for clinical research training and management, offers wide range of full time, part time, class room, online and distance learning certificate /diploma programs, workshops &seminars
    • Cliniminds can help to achieve the level of expertise required , through user-friendly and cost effective training programs
    • Restricted number of students
    • 100 % placement assistance to all students
    • All Cliniminds programs are certified and accredited by the Pharmaceutical society of India and Cliniminds (ISO 9001/2000 certified academy) jointly.
  • 33. Cliniminds Key Team Members
      • Kamal Shahani – Consultant/Industry expert/Trainer
      • Dr. Srinkant Tadipatri, Clinical Research Specialist from United States, ex Pfizer
      • Dr. Suneet Sood, Professor, leading international medical school
      • Dr. U. Kapoor, Senior Manager, Clinical Research
      • Dr. Deepak Bunger, Clinical Investigator, PGI
      • Dr. Amit Bhatt, CEO, Nexus CRO
      • Mr. Vatsal Acharya, Industry Specialist from leading MNC
      • Dr. G.S. Arora, Industry Specialist from leading MNC & Former Professor of Clinical Research
      • Dr. Ramesh C, Princpal, Pharmacy College, Hyderabad
      • Ms. Pooja Saxena, Senior CRA, leading CRA
  • 34. Our Core Areas
    • Clinical Research/Medical/Healthcare Educational Training Programs
    • Course Content Development
    • Management Development Programs
    • Placement Services
    • Business & Consulting Services
  • 35. Programs offered by Cliniminds
    • Classroom Programs, Distance & Online
    • Advance Post Graduate Program in Clinical Research
    • Post Graduate Program in Clinical Trial Management
    • Post Graduate Program in Clinical Data Management
  • 36. Distance & On - Line Programs
    • Post Graduate Diploma in Clinical Trial Management
    • Advanced Post Graduate program in Clinical Research
    • Certified program in Clinical Research
    • Post graduate program in Clinical Data Management
    • Post Graduate program in Pharmacovigilence
    • Post graduate program in Conducting &Managing BA/BE studies
    • Certificate Program in Conducting & Managing Clinical Trials for Cancer Patients
    • Post Graduate program in Quality assurance in clinical research
    • Post graduate program in Regulatory Affairs
    • Post graduate program in clinical research for nurses
    • Post Graduate Program for Investigators & Site Personnel
    • Post Graduate Program for CRAs/Monitors
  • 37. E-Learning Programs-Video Conference Class
    • Advanced PG Program in Clinical Research
    • PG Program in Basics of Biostatistics
  • 38. Workshops &corporate trainings
    • Cliniminds conducts regular interactive workshops on clinical research on regular basis
    • Providing in house training solution for corporates
    • Certificates are provided at the end of the workshops
    • Cost efficient –value for money
    • Customization of workshops as per client needs
  • 39. Eligiblity
    • All from Science backgrounds
    • MD,MS,MBBS,BDS,BHMS,BAMS,Grad-uate /Post Graduate Degree in Science, Pharmacology, Pharmacy, Life sciences , Medical laboratory ,Nursing, Biochemistry, Microbiology ,Biotechnology.
    • All professionals working with Pharmaceutical companies or CROs
  • 40. Methodology
    • Regular classes
    • Printed training modules
    • Workshops
    • Web based testing and examinations
    • Onsite training
    • ICH GCP guidelines and covers schedule Y and CFR 21 compliant programs
  • 41. Educational loans –HDFC Bank
    • All our programs have been approved by the HDFC BANK for the purpose of educational loans for the students
  • 42. Cliniminds (Unit of Tenet Health Edutech Pvt. Ltd. ) No. 420, 1st Floor, 9th Main, Banashankari 2nd Stage, Bangalore - 560070 Mobile: +91-96636-91388 Email : bangalore Website :
  • 43. Thank you