Clinical Research Presentation


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my first presentation on clinical research and its carrier opportunities

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Clinical Research Presentation

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