PowerPoint Presentation

PresentsClinical TrialsNew Horizon India

1

Clinical Trials

The Way We Make Progress Against Disease

Whether you have , are a friend or family member of someone with , or someone who works with people with people who have , this presentation will help answer some of the most important questions you may have about clinical trials.

The presentation will include a discussion about: Why clinical trials are important How clinical trials work How clinical trials advance patient care How participants are protected Some of the barriers to participating in clinical trials

And finally, Ill talk about ways you can find clinical trials in your community.

What Are Clinical Trials?Research studies involving people

Try to answer scientific questions and find better ways to prevent, diagnose, or treat disease

Clinical trials are research studies involving people. Clinical trials are the final step in a long research process that includes preliminary laboratory research and animal testing.Clinical trials try to answer specific scientific questions to find better ways to prevent, detect, or treat diseases, or to improve care for people with diseases. In cancer research, for example, a clinical trial is designed to show how a certain anticancer approachfor instance, a promising drug, a new surgical procedure, a new diagnostic test, or a possible way to prevent canceraffects the people who receive it.

Why Are Clinical Trials Important?Clinical trials translate results of basic scientific research into better ways to prevent, diagnose, or treat disease

The more people take part, the faster we can: - Answer critical research questions - Find better treatments and ways to prevent disease

It is important to understand what clinical trials do to fight disease: Clinical trials translate results of basic scientific research into better ways to prevent, diagnose, or treat disease. Clinical trials contribute to knowledge and progress against disease. Many of todays most effective treatments are based on previous study results. Because of progress made through clinical trials, many people treated for various diseases are now living longer. The more people that participate in clinical trials, the faster we can answer the critical research questions that will lead us to better treatment and prevention options for a range of diseases.

SIGNIFICANCE IN INDIA

Large patient pool with different types of diseasesHighly skilled and trained clinical research professionals and doctorsLow costLess stringent regulations when compared to other regulatory authorities

OPPORTUNITIES

Different domains in Clinical Research which requires qualified and trained individualsClinical OperationsData ManagementPharmacovigilanceMedical WritingRegulatory, etc.

India Vs US

The journey towards becoming an attractive new destination for clinical researchAccelerationAcceptanceAttraction

1992 1996 2000 2004 20082012

61 Companies 100 CROs80 Hospitals150 Investigators registered with US FDA

Overall Country attractiveness index : India 2nd most preferred destination Czec. Rep. U.K.

ChinaIndiaRussiaBrazilArgentinaPoland HungaryGermanyTaiwanIsraelSingaporeIrelandSouth AfricaUnited USA6.105.585.555.265.005.004.904.844.814.694.464.284.273.864.566.88

Patient poolCost efficiencyRegulatoryconditionsRelevantexpertiseInfrastructure &environmentScale : 1-10

CountryAll Studies% Industry SponosredAustralia157262.72Chinese Taipei90345.29Japan73267.76Korea67472.26China64353.50India58272.16Singapore33568.36Thailand32769.42Chinese Hong Kong25082.00Philippines20693.20Malaysia18093.33

CLINICAL TRIAL ACTIVITIES IN ASIA ALL STUDIES

Large No. of specialists in different therapy segments Medical Training In English 600,000 Eng. Speaking physicians Large no. of ICH/GCP compliant Investigators / sites Large, Diverse, therapy-nave Advantage of having 6 out of 7 genetic varieties Large pt. pool in acute/chronic disease segment Increasing no. of pts in life style disorders segment, HIV, OncologyIndia : Resource advantagesPatient population

Investigators

India : Resource advantages Over 200 Medical Colleges Over 22,000 graduates per year 15,622 hosp., 903,952 hosp. beds >75% in urban area 14000 diagnostic labs 700,000 scientists and engineering graduates / year World class medical / lab facilities at secondary / tertiary care centers Skilled computer savvy biomedical work force Highly developed IT / ITES Motivated & committed personnel Clinical Research InfrastructureIT Support Connectivity High quality digital connectivity Excellent air/surface transport facilities across country

In conclusion.

ScantyLargeIndia

Patient pool

Lowest rateHighest rateIndia

Patient Recruitment rate

LowHighIndia

Speed

Most expensiveLeast expensive India

Cost

Smallest poolHighest poolIndia

Facility & Investigator pool

Unacceptable to EU/USAcceptable to EU/USIndia

Quality of data

Least ConduciveMost ConduciveIndia

Regulatory Environment

Least experienceMost experienceIndia

Industry trialexperience

International CollaborationsWHOUSA FDAHealth CanadaANVISA, BrazilSouth Africa

ABOUT SYNCORP

SYNCORP!! is a leading Indian owned Clinical Research Training and Service Provider. We offer end to end solutions to the pharmaceuticals, biotech and clinical research industries.

Syncorp- The Clinical Research Company

CR SERVICESACADEMICSSYNCORP

Authorized Franchisee Partner TN & AP

The CR Industry In India

India is becoming a hub for clinical research; the demand for professionals in this field is growing rapidly .Clinical research business in India will be worth $1.5 billion by 2012. Thus, there will soon be a massive demand for clinical research professionals, making it an interesting career option with massive growth potential A large population with a substantial workforce and cost benefits influence multinationals to set up research facilities here. Besides due to the prevalence of a large variety of diseases, including widespread cases of cancer and diabetes India is viewed the world over as the ideal location for clinical research

All GCP certified trainersAll trainers from reputed Clinical Research IndustryAs your choice you can select any course modulePractical oriented class room programmesCourse fees very reasonable & you can pay in 2 3 installments Not required to pay any extra fees for books, study materials or handouts. Live Clinical Research Project

How you will be benefited from Syncorp

Whether you have , are a friend or family member of someone with , or someone who works with people with people who have , this presentation will help answer some of the most important questions you may have about clinical trials.

The presentation will include a discussion about: Why clinical trials are important How clinical trials work How clinical trials advance patient care How participants are protected Some of the barriers to participating in clinical trials

And finally, Ill talk about ways you can find clinical trials in your community.

Career ProspectsQualified professionals can look forward towards rewarding careers asClinical Research CoordinatorClinical Research AssociateData ManagementRegulatory AffairsQA & QCPharmacovigilanceMedical Writers & many more

Careers Pathway

Cont.

Classroom Programmes:Advance Diploma in Clinical ResearchAdvance Diploma in Clinical Research & Regulatory AffairsAdvance Diploma in Clinical Research & Clinical Data ManagementPost Graduate Diploma in Clinical Research & PharmacovigilancePost Graduate Diploma in Clinical Research and Clinical Data Management Including SASPost Graduate Diploma in Clinical Research and Medical WritingSome Special CoursesBusiness Management ResearchStatistical Tools (SAS) in financial sector, market research and clinical researchEligibility Criteria for the CourseMBA/ MCA/ BTech/Mtech/MSc/BSc/BcomAll PG Courses includes Practical Oriented On Job Internship-in Ongoing Clinical Trials at SYNCORPs Clinical Sites All Over India Or Clinical SAS Internship. Distance Learning courses also Available

Eligibility Criteria for Any Course

M.B.B.S/B.D.S/BPharm/M.Pharm/BHMS/BAMS/BE Biotech/ME Biotech/Nursing. M.Sc/ B.Sc in Biotechnology , Microbiology , Biochemistry, Genetics or Life Sciences For Medical Writing courses only Medical Science Graduates/ B. Pharm / M. Pharm Final Year Interested Students Are Also Eligible**Terms and conditions apply

CONTACT US @ TIRUPATI

Clincare Institute for Research and Training A Division of NIDES

Authorized Franchisee Partner Syncorp

1-6-11/C | RS Gardens | Maternity Hospital Road | Tirupati 517501Ph: +91 96760 01317 | +91 96760 01595 | www.nides.inEmail enquiry@nides.in

CDSCO

India : Your Gateway to Clinical Research & R&D

Let us not follow a path set by othersLet us set a path for others to follow

THANK YOU

SYNCORP Clincare Technologies (P) Ltdwww.syncorp.in

Clincare Institute for Research and Training A Division of NIDES1-6-11/C | RS Gardens | Maternity Hospital Road | Tirupati 517501www.nides.in