in india clinical research scenario - ossinc · hospitals, sanofi aventis. india’s sound...

CLINICAL RESEARCH SCENARIO IN INDIA

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Clinical trials

A clinical trial is a research study in human volunteers to get the answers of specific

health questions. Carefully conducted clinical trials are the safest and fastest way to find

treatments that work in people, and new ways to improve health.

There are different kinds of clinical trials, including those to study:

Prevention options

New treatments or new ways to use existing treatments

New screening and diagnostic techniques

Options for improving the quality of life for people who have serious medical

conditions

Clinical trials are conducted according to a plan called a protocol. The protocol describes

what types of patients may enter the study, schedules of tests and procedures, drugs,

dosages, and length of study, as well as the outcomes that will be measured. Each person

participating in the study must agree to the rules set out by the protocol.

Many clinical trials are done to see if a new drug or device is safe and effective for people

to use. Clinical trials are also done for other reasons. Some compare existing treatments

to determine which is better. The current, approved treatments are called the "standard

treatments." Sometimes clinical trials are used to study different ways to use the standard

treatments so they will be more effective, easier to use, and/or decrease side effects.

Sometimes, studies are done to learn how to best use the treatment in a different

population, such as children, in whom the treatment was not previously tested.

For most trials, researchers, doctors, and other health professionals administer the clinical

trials according to strict rules set by the Food and Drug Administration (FDA) and/or

country specific regulatory bodies. FDA sets the rules to make sure that people who

agree to be in studies are treated as safely as possible.

Clinical Research In India

The Indian Clinical Research Industry, Valued at Rs. 8,000 crore ending fiscal 2010-2011,

is making rapid strides in the global arena leaving even China way behind in conducting

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clinical trials according to experts. The industry which was valued at Rs. 1,200 crore in

2006 has grown to Rs. 6,500 crore in 2009-10

The key growth factors driving the sector are the sound medical expertise, English

speaking work force, capability in information technology, large patient pool and modern

hospital infrastructure. Supporting these capabilities are quick turn around time and the

data management skills.

The global economic slowdown which has seriously impacted western world has

benefited the Indian clinical research industry. Scores of assignments are pouring in to

conduct clinical trials, pharmacovigilance studies and data managemeny works.

The India clinical trials industry has around 60 major players. Of these the leading names

are global players like Quintile, Pharma Net, Pharma Olam and Clin Tech International

to name a few. The well-known Indian names include Ecron Acunova, Lotus Labs,

Clingene, part of Biocon Ltd, Omnicare, ICON, Vaatsalya, St. John’s Medical College

Clinical Trial Centre, Triesta Life Sciences part of Health Care Global Enterprises Ltd,

Siro, Synchron, D2L, SMO India and Infinitus.

According to Dr. Saral Thangam, Technical Director, Lotus Clinical Research Academy,

the main attraction of India is the availability and confidence in the qualified trained

personnel comprising pharmacy graduates and doctors who are sound in spoken and

written English.

In fact, the global recession had led companies in the West to largely look at low cost

markets which include India and China. However, India is preferred to China in the area

of clinical record documentation because of the better standards in English, she added.

According to Ahis Mukherjee, Senior Director, Hospitals & Oncology BU and Corporate

Hospitals, Sanofi Aventis. India’s sound knowledge in information technology has been a

key growth driver of the clinical research industry. Although the clinical research industry

started off in India in 1992, it gained momentum only from 2004 and the last three years

have seen an exponential growth. An important factor for such fast paced activity in the

sector is the sound IT and English skills supported by qualified doctors, trained medical

personnel including investigators, research-hospital infrastructure, economies-of-scale

and access to recruiting large number of patients. There is a huge disease burdenin the

country from cancer, diabetes, tropical fevers to genetic disorders.

The installation of electronic medical records (EMRs) by hospitals in the country have

also proved as a major attraction for international clinical research organizations (CROs)

and multinational companies to offload human studies to India, he added.

There is a growing global demand for clinical trial management which provides

opportunities in IT specific to clinical trail industry. These include data management and

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medical writing which have widened the scope for outsourcing clinical research business

to India.

India is now at the helm of clinical research and speed is the essence of this sector.

Pharma companies are looking to hasten the drug development process and CROs are

scrambling to access right talent. Clinical research training centres are working to groom

candidates as industry ready professionals at a faster pace, said Dr. Ramananda S Nadig,

Dean and Chief Operating Officer, Clinical Research Education Managemnent Academy.

The Hospital infrastructure and medical expertise have facilitated smooth conduct of

phase-III and phase-IV human studies. However, India needs to look at conducting

phase-I trials immediately. The expertise in phase-III and phase-IV have given the

country much of the recognition to become a hub in clinical research. In order to grow

the clinical research industry here,phase-I needs to be taken on. The country has been a

hub for human studies cardiology, oncology, diabetes, thrombosis, central nervous

system disorders and tropical diseases.

Global companies are eager to set up pharmacovigilance centres in India. The CROs here

have demonstrated competence in quality deliverables in human studies and

pharmacovigilance is an extension of this which covers reporting of adverse drug reaction

(ADR) and post marketing surveillance.

In fact, for CRO pharmacovigilance is a logical extension. Even Indian pharma

companies have started pharmacovigilance as back end services. IT majors like

Accenture, TCS and Infosys are particularly focusing on pharmacovigilance, according to

Sudhir Pai, Managing Director, Lotus Clinical Research Academy.

Clinical research education along with the worldwide growth in clinical trials,

enforcement of regulation has become stringent. In India Schedule Y is considerably

regulating the industry. According to Dr. Arun Bhatt, President, Indian Society for

Clinical Research and President, ClinInvent Research India Pvt Ltd, the Government of

India should notify amendment to ScheduleY-1 without delay so as to make registration

of clinical research organizations mandatory in the country . In this regard, the Indian

Society of Clinical Research had worked on the revised guidelines and made a submission

to the Drugs Controller General Of India (DCGI) in September 2009. Only a speedy

tabulation of the guidelines could provide the industry the much needed fillip, he added.

Supporting this strict adherence and creating an awareness on the need to ensure right

conduct of human studies, the clinical research training and education has become a

mandatory part of this industry.

The estimated trained professional shortage in the Indian clinical research industry is at

65,000, of which 15,000 are for pharmacovigilance jobs alone “ Global demand is

annually around 2.50 lakh trained professionals of which only four percent of the

requirements is met,”one of the Industry sources said.

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There are bright career opportunities in this industry in India for professionals like

Doctors,Pharmacy,IT and Science graduates and Post graduates.

The transfer of jobs from global locations to India will give an opportunity to Ecron

Acunova to scale up operations and improvise processes, said DA Prasanna, Founder ,

Ecron Acunova.

There is also an expansion of facilities by CROs. GVK Biosciences has commissioned its

new clinical pharmacology unit (CPU) in Ahmedabad. The DCGI-audited facility is the

second centre after its Hyderabad unit which has added 110 beds to the company’s

existing capacity of 144 beds and will aid faster recruitment solutions to our global

customers, said Manni Kantipudi, President, GVK Biosciences.

Challenges

Despite the presence of large and young team of clinical research professionals, they lack

training on Good Clinical Practices (GCP) and Good lab Practices (GLP). Other issues

are that medical education curriculum in India does not have a component on research

methodologies and there is no standardized training on clinical research. In addition,

there is also a need for accreditation of hospitals on similar lines of NABH for sites

selected to carry out human studies, opines Mukherjee

Potential Employers

The potential for our industry in India is tremendous and presents an attractive

opportunity spectrum for contract research organizations. The clinical trials industry in

India was estimated at $485 million in 2010 by Frost & Sullivan and is projected to grow

at 17 percent CAGR from 2009-15, remaining the largest clinical trial market in Asia after

Japan. This growth is being fuelled not just by the global majors, but also by the

innovative and generic domestic companies who have witnessed rapid growth over the

past three years. Global biopharma companies accounted for 90 percent of Quintiles

clients in Asia only three years ago but today the split between global and local clients is

closer to 50:50.

There are more than 3000 potential organization to employ various trained professional.

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Few CROs who are potential employers and many more pharmaceutical

companies interested in employing trained candidates.

Accutest Research

Laboratories

web: www.accutestindia.co

m

Ace Biomed

web: www.acebiomed.com

Actimus Biosciences

web: www.apothecaries.net

Asian Clinical Trials Pvt

Ltd

web: www.act-india.com

C B Patel Research Center

web: www.cbprc.svkm.ac.in

Clinexa Life Sciences

web: www.clinexa.com

Clinigene International

web: www.biocon.com

Clininvent Research

web: www.clininvent.com

Vimta Labs

web: www.vimta.com

ClinTec International India

web: www.clintec.com

D & O CRO

web: www.dnogroup.com

Dr Lal PathLabs Pvt Ltd

web: www.lalpathlabs.com

GVK Biosciences Pvt Ltd

web: www.gvkbio.com

iGate Clinical Research

International

web: www.igatecorp.com

INTOX Private

web: www.intoxlab.com

Jubilant Clinsys

web: www.jubl.com

Kendle India

web: www.kendle.com

Lambda Therapeutic

Research Ltd

web: www.lambda-cro.com

Lotus Labs

Manipal Acunova

web: www.acunovalife.com

Mayfair Clinical Education

and Research Center

Thane, Maharashtra 400

607

Metropolis Clinical

Laboratories

web: www.metropolisindia.

com

Neeman Medical

International (Asia)

web: www.neeman-

medical.com

Omnicare Clinical

Research India

web: www.omnicarecr.com

PPD Pharmaceutical

Development India

web: www.ppdi.com

Parexel India

Bangalore

Quintiles Spectral Private

http://www.accutestindia.com/

http://www.accutestindia.com/

http://www.acebiomed.com/

http://www.apothecaries.net/

http://www.act-india.com/

http://www.cbprc.svkm.ac.in/

http://www.clinexa.com/

http://www.biocon.com/

http://www.clininvent.com/

http://www.vimta.com/

http://www.clintec.com/

http://www.dnogroup.com/

http://www.lalpathlabs.com/

http://www.gvkbio.com/

http://www.intoxlab.com/

http://www.jubl.com/

http://www.kendle.com/

http://www.lambda-cro.com/

http://www.acunovalife.com/

http://www.acunovalife.com/

http://www.metropolisindia.com/

http://www.metropolisindia.com/

http://www.neeman-medical.com/

http://www.neeman-medical.com/

http://www.omnicarecr.com/

http://www.ppdi.com/

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Wellquest

Wellspring Hospital (6th

floor),

web: www.nicholaspiramal.

com

SRL Ranbaxy Clinical

Reference Laboratories

web: www.srlranbaxy.com

Statkon

Powai, Mumbai,

Maharashtra 400076

Pharmaolam

Bangalore

web: www.lotuslabs.com

Sterling Synergy Systems

web: www.sterling-

synergy.com

Synchron Research Services

web: www.synchronresearch.

com

Asiatic Clinical Research

Mumbai

ICON Research

Bangalore

web: www.quintiles.com/i

ndia

Reliance Clinical Research

Services

Mumbai

Sipra Labs Pvt Ltd

web: www.sipralabs.com

SIRO Clinpharm

web: www.siroindia.com

Sitec Labs

Mumbai, Maharashtra 400

083

About us

The organization established in the year 2008 has become pioneer in clinical research

training and education in last three years.

Till date we have trained more than 100 students and got them placed in various reputed

companies eg : Max Neeman International, Cipla, Lincoln , Quinlon pharma , Ajanta

Research ,Lupin , Abbot India, Modi Mundipharma , GSK India ,Cytespace etc.

Our courses are well designed in collaboration with various Industry experts of India and

Europe.

http://www.nicholaspiramal.com/

http://www.nicholaspiramal.com/

http://www.lotuslabs.com/

http://www.sterling-synergy.com/

http://www.sterling-synergy.com/

http://www.synchronresearch.com/

http://www.synchronresearch.com/

http://www.quintiles.com/india

http://www.quintiles.com/india

http://www.sipralabs.com/

http://www.siroindia.com/

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Training Concept :

The training programs developed by our team requires minimum time with maximum

literature. It is a completely job oriented program which eliminates all the unnecessary

training and literature .

The program can be opted while studying or even during any job. It incorporates text

books ,handouts, Modules and online support.

The training center located in Lucknow is one of the largest research center of the north

with all the modern facilities . The student can visit the training centers for workshop and

other information.

The courses are designed for specific colleges and many new modules are added as per

college curriculum and requirements.

The institute also has online forum where updates about the clinical trials can be

obtained.

Training Faculty and Trainers

Dr Shashank Tiwari

Course Coordinator

GCP expert and Ethics Analyst

Dr Divolika Jatana

GCP expert

Dr Naveen Kesarwani

Schedule Y Specialist

Mr Mohit Singh

Clinical Research Regulation Expert

Dr Gourav Kumar Saha

Medical Training Expert

Dr Sudeep Verma

Clinical Research Operations Expert

Dr Devesh Kumar Saxena

Industrial Training Expert

Fortis Clinical Research

Dr Sandeep Kumar Gupta

Medical Aspects of Clinical Trials

M V Hospital and Research Center

Dr Mohd Fahad Khan

Ethical Regulation ,

M V Hospital and Research Center

Dr Sumit Srivastava

Industrial Training Expert

Indipharm India

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Other 20 guest members specialized for various clinical research aspect as

well as international speaker available on request .

COURSE CONTENT AND TOPICS COVERED :

1. Clinical Research : An overview

2. Ethical Issues in Clinical Research

3. ICH Good Clinical Practice (GCP)

4. Informed Consent and Protocol Design

5. Clinical Trial Activity and Trial Designs

6. Ethics Committee

7. Drug safety and Pharmacovigilance

8. Clinical Trial Monitoring, Auditing and Inspection

9. Clinical Data Management and Bio Statistics

10. Legal Issues in Clinical Research

11. Clinical Trial Outsourcing

12. Medical Writing

13. Miscellaneous and Other aspects.

14. Tips and Tricks

15. Field work for practical experience

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Courses only for Colleges

Course Code : OSS-10/GCP

Course Fees : Rs.10,500/-

Training Team : OSSINC Team India

Course Type : Distant learning with optional One day workshop

Course Material : Exclusive Modules and guidelines


Course Fees : Rs. 15,500/-


Course Type : Distant learning with optional One day workshop

Course Material : International Book and Module


Course Fees : Rs. 22,500/-


Course Type : Distant learning with optional Three day workshop

Course Material : International Book and Module

For Further details please email to [email protected]

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Courses Open For All

Code: OSS-05

Type of Course : Clinical Research Certification Course

Duration : Three months

Fees : Rs. 30,000/- + Rs. 2,000/-

Training type : Distant learning + 45 days(100 Hrs) onsite training

Course Details : Global Exclusive Certification course for three months(Only

programme in the world that incorporates textbooks and onsite training along

with corporate interface), 45 days correspondence learning sessions from training

team in U.K. , 45 days onsite training on Global Studies/Projects at centers across

India. Includes five very exclusive books (Exclusive and Copy Write) of Helix

Worldwide and Centerwatch.






6. Ethics Committee






12. Medical Writing


14. 06 step Assessment


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Code : OSS-07


Duration : One month

Fees: Rs 20,000/- + 7,000/-

Training type : Distant Learning + Onsite training for seven days.

Course details :

1.Three International Text books of Clinical Research

2.Three modules of Clinical Research

3.Various clinical research related material ,Templates ,Articles etc.

Topics Covered :






6. Ethics Committee






12. Medical Writing




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Code : OSS-08

Type of Course : Clinical Research certification Course

Duration : Two months

Fees : Rs 25,000/-

Training type : Distant Learning

Course details :

1.Three International Text books of Clinical Research



Topics Covered :






6. Ethics Committee






12. Medical Writing




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Code : OSS-09


Duration : Three month

Fees : Rs 8,000/- + Rs 2,000/-

Training type : Distant learning with one day optional workshop

Course details :

1.One International Text books of Clinical Research



Topics Covered :






6. Ethics Committee






12. Medical Writing




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Contact Details

OSSINC INSTITUTE OF CLINICALRESEARCH OSSINC International,

Tr. Centre: M V Hospital and Research Center 314/30 , Mirza Mandi Chowk,

Lucknow-226003 Uttar pradesh

India P: +91-522- 2662928 , +91-522-2662828

F: +91-522-4016051 M: 09838172269 ,09733269392, 07379737763

An OSS Research International INC Initiative AN ISO 9001:2008 CERTIFIED ORGANIZATION

website : www.ossinc.org

in india clinical research scenario - ossinc · hospitals, sanofi aventis. india’s sound...

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