Clinical Research Presentation

my first presentation on clinical research and its carrier opportunities

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

29. CLINIMINDS

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
1.Kamal Shahani – Consultant/Industry expert/Trainer
2.Dr. Srinkant Tadipatri, Clinical Research Specialist from
United States, ex Pfizer
3.Dr. Suneet Sood, Professor, leading international medical
school
4.Dr. U. Kapoor, Senior Manager, Clinical Research
5.Dr. Deepak Bunger, Clinical Investigator, PGI
6.Dr. Amit Bhatt, CEO, Nexus CRO
7.Mr. Vatsal Acharya, Industry Specialist from leading MNC
8.Dr. G.S. Arora, Industry Specialist from leading MNC &
Former Professor of Clinical Research
9.Dr. Ramesh C, Princpal, Pharmacy College, Hyderabad
10.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: [phone]
Email : [email protected]
Website : http://www.cliniminds.com

43. Thank you