Anovus

P R O S P E C T U S

Affiliated to

Punjab Technical University

An Initiative of

Hit Abhilashi Foundation

Join the hi-value, hi-incomemulti-billion dollar clinical research industry

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Welcome to the worldof Clinical Research

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Messages

Vice Chancellor, PTU

Dean DEP, PTU

Director, Anovus

Advisory Board

Clinical Research: A multi-billion dollar Industry

Clinical Research Industry

Career Prospects in Clinical Research

Anovus Institute of Clinical Research

Course Delivery & Campus Facilities

Faculty

Studying at Anovus

Courses & Fee Structure

Clinical Research at Fast Track (CRAFT)

Admission Procedure

Campus Activity

Training & Placement

It gives me immense pleasure to add

another first to Punjab Technical

University by pioneering modular Clinical

Research Education & training through

its affiliate Anovus Institute of Clinical

Research, Chandigarh. This association

highlights continuous efforts of PTU to

impart highly advanced courses under its

direct observation for the benefit of the

students of India.

The area of Clinical Research is a highly

demanding field requiring experts

having thorough knowledge of drugs,

principle of research, regulatory

requirements, IT, Management besides

being trained in soft skills.

AICR has shown its commitment to

provide all the required elements of

success to the students. I wish team

Anovus, a great success.

Dr. Rajneesh Arora Vice Chancellor

PTU is fast achieving its goal of being the

University of choice. Established in

January 1997 for advancement of

Technical Education, the University has

292 affiliated Colleges and 17 Regional

Centres and more than 1600 Learning

Centres offering Courses in Engineering,

Management, Pharmacy, Achitecture,

Hotel Management, Medical Lab

Technologies, IT & Non-IT discipline.

The Learners here are Industry ready and

trained to challenge assumption and

think beyond visible limits taking up

newer challenge and opportunities.

Crossing another such frontier is the

offering of India's first modular program

in Clinical Research.

The Clinical Research market worldwide

is worth over $52 Billion. There are more

than 2,50,000 position vacant globally.

These large number speak volumes

about the lucrative career and its infinite

employment opportunities. Clinical

research market in India is growing at a

compounded annual growth rate

(CAGR) of 60 percent. India is already the

third largest destination for Clinical trials.

In this background this course is PTU's

initiative in development future-ready

professionals.

The world today is not limited by choice

or technology, but only by the power of

one's imagination and initiative. This is

my message to the student joining this

course or graduating out.

My best wishes to you for an exciting

acedmic journey .

Life sciences are now quickly moving to

occupy the centre stage in the Indian

economy. The next ten years will belong

to the practitioners, Companies and all

those who are associated with life

sciences. Coupled with the unique

intelligentsia-price-population synergistic

advantage that India offers it has

become the world's favoured destination

for all non-manufacturing activity,

particularly for Knowledge processes and

services.

The McKinsey Report estimates Clinical

Research to become a Rs 5000 crore

industry by next year and would be

requiring about 50,000 Clinical Research

professionals. The demand worldwide

too is huge and given the shortage of

quality Clinical Research professionals

they are attracting lucrative salaries.

Anovus, with the best faculty,

infrastructure, industry linkages and

backing of highly seasoned and

renowned advisory board will give the

students cutting-edge knowledge and

grooming in high ethical standards to

make them leaders among their peers

and to play a perceptible role in shaping

the destiny of the nation.

We have introduced Clinical Research at

Fast Track (CR@FT) Programme to give a

clear advantage to our students. We

shall continue to innovate, update and

build national and international

affiliations to give them a headstart in a

highly competitive world.

Welcome to Anovus.

Anovus provides cutting edge knowledge...

PTU’s another first by pioneeringmodular clinical research education ...

Dr. Dharinder TayalDirector, Anovus

Dr. N. P. SinghlDean (DEP)

PTU is fast achieving its goal of being the University of choice

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Advisory Board

The KnowledgeBank

Anovus is proud

to have a highly

knowledgable

and reputed Board

of Advisors.

Prof Jagdish ShethCharles H. Kellstadt Professor in the Goizueta Business School at Emory University. Member, Board of Directors, Wipro Limited.

Dr K N PathakFormer Vice Chancellor Panjab University

Mr. Alok SonigManaging DirectorBristol-Myers Squibb India Pvt. Limited

Dr H DattaDM Clinical Pharmacology, PGIEx-Professor & Head of Pharmacology Department, PGI

Dr Roma UppalDM Clinical Pharmacology, PGI

Mr Arvind SinghalChairman Technopak Advisors Pvt Ltd

Mr Abhaya KumarDirector & Co-Founder, Shasun Chemicals & Drugs; Vice Chairman Life Cell International

Dr H P S ChawlaDirector, Unimark Remedies Ltd, Former Professor & Dean, National Institute of Pharmaceutical Research (NIPER)

Mr K L Khurana Former Vice President, Ranbaxy Laboratories Ltd

Mr Arvind VasudevaManaging Director, RPG Life sciences Ltd

Mr Romy JunejaFounder MobileNXT

Dr Dharinder TayalDirector, Bank of Rajasthan LtdMember Senate, Panjab University

Phase I trials

This is the first time the new drug is

administered to a small number, around 20-80

healthy, informed volunteers under the close

supervision of a doctor. The purpose is to

determine whether the new compound is

tolerated by the patient's body and behaves in

the predicted way.

Phase II trials

In this phase, the medicine is administered to

a group of approximately 100-300 informed

patients to determine its effect and also to

check for any unacceptable side effects.

Phase III trials

In this phase, the group is between 1000 and

5000, for the company to use statistics to

analyze the results. If the results are favorable,

the data is presented to the licensing

authorities for a commercial license.

Clinical Research a multi-billion dollar industry

Phase IV trials

This is a surveillance operation phase after

the medicine is made available to doctors,

who start prescribing it. The effects are

monitored on thousands of patients to help

identify any unforeseen side effects.

Research : 6-8 Years Development: 10-15 Years costing $1.2 - 1.5 billion

30-40% of all new drugs fail due to poor performance at theanimal - human transition

Phase 11-2 Years

Phase 21-2 Years

Phase 31-2 Years

Phase 4FDARegistration

1 2 3 4

Clinical Research is

a systematic study

of new and

existing drugs in

human subjects to

generate data for

discovering or

verifying the Clinical,

Pharmacological

(including

pharmacodynamic and

pharmacokinetic) or

adverse effects with

the objective of

determining safety

and efficacy of the

new drug.

What is Clinical Research?

Clinical Research is conducted in 4 four Phases

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A Global Prospective

Clinical Research Industry has grown around

the world at an unparalleled rate in the past

few years. It has opened up new

opportunities of employment for a large

number of people. The Clinical Trials market

worldwide is worth over US$ 45 billion and

the industry has employed an estimated

2,10,000 people in the US and over 70,000

people in the UK forming one third of the

total Research & Development staff. The

clinical trials industry has clear potential for

strong growth in the future, driven by

technological and scientific advances.

An Indian Prospective

India is increasingly becoming the hub of

clinical trials for all major pharma companies

across the world due to its advantages of

treatment naïve patient population, state of

the art and yet cost effective trial sites, high

percentage of English speaking medical

professionals and timely completion of the

projects.

North India has a clear advantage for clinical

research because of the availability of many

world-class super specialty hospitals and

research institutes including PGIMER,

National Institute of Pharmaceutical

Education and Research(NIPER), Institute of

Microbial Technology(IMTECH), Fortis

Hospital, Apollo Hospital, CMC, DMC, PGIMER

Srinagar etc.

Clinical Research Industry

2003 2008 2010

Value (million USD) 50 200 1000

Full time staff requirement 800 4000 20,000

Site-staff requirement 1500 6000 30,000

Patient load 10,000 50,000 300,000

Revenue ProjectionsMan Power Requirements inClinical Research Industry in India

Source : McKinsey report

Business growth has been 4 times in 5 years and is expected to be 5 times in next 2 years.

Total staff requirement by 2010 is expected to be 50,000.

A great future for India

The Clinical Trials

market worldwide

is worth over

US$ 45 billion and

the industry has

employed an

estimated 2,10,000

people in the US

and over 70,000

people in the UK

forming one third

of the total Research

& Development staff.

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A great future for India

Career Prospects in Clinical Research

There are fast

growing job

opportunities for

a clinical research

professional in

various sectors in

the health

eco-system.

1.2%

1.3%

1.7%

3.7%

5%

1.1%

4.6%

34.9%

26%

20.5%

Opportunities UnlimitedPharmaceutical/biopharmaceutical/biologics

Contract research organization

Clinical study investigative sites (includes)academia, medical research facility)

Drug development, clinical trials consulting company

Medical devices

Total/Site management organisations(TMO/SMO)

Independent CRA

Clinical laboratories

Government

Other

Take your pick!A large number of slots are lying vacant for Clinical Research Professionals

Clinical trialCEO/MD

Business Development

Director

Project Management

Director

DataManagement

Director

InvestigationDirector

TrainingDirector

BD Manager Project Manager Data Manager Principal

InvestigatorTraining

Coordinator

BD executiveClinical

Team LeaderBio-statisticion Investigator Trainer

SeniorCRA

Coordinator

CRA

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Source: Applied Clinical Trial Survey, July 2008

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An Overview

Institute of Clinical Research

Our Mission

To create a team of

expert clinical

researchers through

world class education,

practical experience,

and partnership with

leading players in

the health eco-system,

who are committed

to advance ethical

and professional

clinical research to

help pharmaceutical

companies develop

appropriate drugs

to combat disease

and ensure health

for all.

he world needs Clinical Researcher to

ensure a disease-free healthy future for

the people. The dire need of the Tpharmaceutical industry is to produce drugs

that can effectively cure the critical diseases in

the world. Ethical clinical trial is the first step

to this.

Anovus Institute of Clinical Research,

promoted by Hit Abhilash Foundation, has

been established as the first Centre of

Excellence north of Delhi, to promote this

mission with the support of the reputed

Government-University, Punjab Technical

University, Jalandhar.

Anovus is the only institute in the country to

offer two-years post-graduate Degree in

Clinical Research which is modular in nature.

Anovus is a professionally managed institute

dedicated to provide world-class education in

the emerging field of clinical research.

Anovus is committed to

nTrain professionals in ethical clinical

research to meet the growing demand of

the health industry.

nTo ensure speedy trials of newer drugs to

combat disease and ensure health for all.

nBenchmark international standards of

excellence in clinical research.

nIntegrate the industry knowledge and

feedback with the academic curricula for

more effective and efficient delivery of

appropriate clinical research education.

nSpearhead a movement for ethical

clinical research in the country by

providing a platform to all the

stakeholders in the health ecosystem to

exchange knowledge and create a

roadmap for development of clinical

research culture.

nPromote international ethical standards

in clinical research.

nEmerge as a thought leader in clinical

research and a centre of excellence

through national and international

conferences, seminars and workshops.

nNetwork with national and international

clinical research professionals,

academicians, pharmaceutical industry

leaders, and regulatory bodies for a free

exchange of ideas.

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ISO: 9001- 2008Certified.

Member ETHICS COMMITTEE

Hit Abhilashi Foundation, the promoters of

Anovus, have set up the region’s first

independent Ethics Committee as per

ICMR guidelines to stimulate clinical

research in this area.

Most conducive ambiance forlearning

Course Delivery &Campus Facilities

he institute has excellent infrastructure

and modern facilities which assist in

conducting various academic Tprogrammes.

Class rooms are air-conditioned, comfortable

ergonomic seating, and equipped with

modern digital teaching aids, and broadband

wi-fi, to facilitate the learning process.

Facilities & Delivery

nClassroom teaching by eminent faculty

nTeaching aids include hi-end audiovisual

systems, computers, plasma screen, wi-fi,

well-stocked library .

nStimulated situations and role-plays to

give students an insight into

understanding of responsibilities of

various professionals involved in Clinical

Research.

nPractical assignments including Protocol

Designing , preparation of CRFs (Case

Record Forms), ICF (Informed Consent

Forms), PIS (Patient Information Sheets)

and PMS (Post-Marketing Surveillance

Studies).

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students understand real-life Clinical

Research protocol

nExercises with data on Toxicology, Bio-

availability, Bio-equivalence is made

available to the students to draw

inferences, graphs and calculations from

the same. Exercises are also in the form

of MCQs (Multiple Choice Questions),

Q/A (Questions & Answers), and report

writing.

nWorkshops for students on problem-

solving

nWorld's leading data analysis software,

SAS, is taught to the students to help

them work in an IT-enabled

environment for researching the

findings through industry-approved

technology platform.

nA special focus on management skills

ensures that all the graduating students

are industry-ready and immediately

employable.

nComputer lab and broadband wi-fi.

Case Studies methodology to help Anovus

is a pioneering

clinical research

institute affiliated

to the reputed

UGC-approved

government-

university -

Punjab Technical

University.

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As a pioneering Clinical Research institute in the north, Anovus will help meet the

increasing demand for CR professionals by the healthcare sector. With qualitative IT

inputs including SAS training which is much in demand as also its industry validated

curriculum and excellent faculty will ensure that Anovus students are 'industry ready'.

Partap AggarwalCo-founder & Managing Director, IDS Infotech Ltd. Chairman of Indo American Chamber of Commerce for the states of Punjab, Haryana & Himachal. Chairman 2008-10, Confederation of Indian industry (CII) Chandigarh

Faculty

Making learninga pleasure

Anovus has a

distinguished

permanent faculty

as well as visiting/

guest faculty with

rich experience.

Dr Sunita PatelMD (Pharmacology)

Dr H DattaDM Clinical Pharmacology, PGIEx-Professor & Head of Pharmacology Department, PGI

Dr Roma UppalDM Clinical Pharmacology, PGI

Dr Dharinder TayalBE, MBA (XLRI), PhD

Ms Malvika VohraM.Sc. Clinical Research

Ms JaspreetM.Sc. Clinical Research

Ms Madhuri BansalB.Tech (PEC), MBA

Mr Atul Tak MCA, MSc (IT)

Dr Renu TayalMD (PGI)

Ms Stacy LeighSenior Director (Account Management)Perceptive Informatics (A PAREXEL Company), USA

Mrs Richa Luthra Director, Client Account Management, Perceptive Informatics (A PAREXEL Company), USA

Prof Karan VasishtChairperson University Institute of Pharmaceutical Sciences (UIPS), Panjab University

Prof Meenakshi MalhotraUniversity Business School (UBS) Former Dean Panjab University

Prof V.R. Sinha UIPS, Panjab University

Prof Deepti Gupta Dept of English Panjab University

Dr Manoj Kumar UIPS, Panjab University

Dr Kanwaljit ChopraUIPS, Panjab University

Dr Anil Kumar UIPS, Panjab University

Mr Navneesh Bansal GM (Projects), Panacea Biotec

Mrs Nisha SAS Certified Trainer

Visiting/Guest FacultyFaculty

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Payment of fee

The fee must be paid by Demand Draft

before the start of the semester, as per the

schedule specified by the institute in favour

of “Registrar, Punjab Technical University”

payable at Jalandhar. Student has to pay

refundable Library security fee of Rs. 500 at

the beginning of the course.

In case the student does not pay the fee

during the specified time, late fee will be

charged as per dates communicated by the

Institute. The fee is non-refundable in all the

cases. If there is a delay of more than two

weeks, the name of the student will be

deleted from the list.

Candidate cannot change to a shorter-

duration course once the fee has been

deposited with the University by Anovus.

very student is expected to maintain

regular attendance during the Sessions.

The minimum attendance requirement Eis 75%.

Any student remaining absent for more than

25% contact hours for a course will earn an “F”

grade in the Internal Evaluation component.

He/she will not be able to appear in the end-

term examination of that Course.

3rd semester of M.Sc. may be offered in the

A student is expected to weekend option only.

observe the decorum while attending classes,

field visits and during written examinations.

Anovus reserves the right to cancel

candidature of a student if he/she acts in an

unworthy manner.

Award of Degree/Advanced

Diploma/Diploma

A Degree/ Advanced Diploma/Diploma will be

awarded to a student only if he/she has

acquired a pass grade in all the semesters

(required to be completed for award of that

Diploma/Advanced Diploma/Degree).

In case a student does not clear all the

semesters in the maximum time, as determined

by the University, he/she will not be awarded

any Degree. In such cases, no refund of fee will

be made. The candidate can appear for exams

along with next batch by paying the applicable

fee.

The student will have to obtain a No-Dues

Certificate from the Institute prior to allotment

of the Examination Roll no.

StudentInformation

Studying at Anovus

Anovus reserves the

right to update the

programme through

the change in

methodology,

contents, structure

and Scheme of

examination from

time-to-time.

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Courses

Multiple batch

optionStudent has an

option to choose a

batch according to

his/her

convenience and

seats

Semester Each semester

constitutes 200

hours of Theory

and 150 hours of

Practicals.

For MSc training,

last semester

would be for

Research Project

and/or industrial

training.

Modular Flexi-learningProgramme

Programmes & Fee

MSc Clinical Research

Eligibility: Graduation from a Recognised University or Equivalent

Graduation with 1 year Advance Diploma or equivalent in Clinical Research from a recognised University

MSc Clinical Research

Duration: Eligbility: Graduation with 6 month Diploma or equivalent in Clinical Research from a recognised University

Advanced Diploma in Clinical Research

Graduation from a recognised University orequivalent OrFinal year student of graduation with a recognised University or equivalent

Advanced Diploma in Clinical Research

Eligibility: Graduation from a recognised University or equivalent OrFinal year student of graduation with a recognised University or equivalent with 6 month Diploma or equivalent in Clinical Research from a recognised University

Diploma in Clinical Research

Graduation from a recognised University orEquivalent OrFinal year student of graduation with a recognised University or equivalent

Duration: 2 years

2nd year (Lateral Entry): Duration: 1 year

2nd semester(Lateral Entry) 18 months

Duration: 1 year

2nd semester (Lateral Entry): Duration: 6 months

Duration: 6 month

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$ 2050 per semester

per semester$2400

$ 2225 per semester

$ 2225 per semester

$2400 per semester

$ 2050 per semester

The student may have to pay charges for training purposes, if so required by external lab/hospital/industrial organisationas per their norms. These charges will be payable directly to the organisation concerned. Student earning any stipendduring training will retain the same.

Student has to pay the full-semesterfee at the beginning of each semester by a Demand Draft drawnin favour of “Registrar, PunjabTechnical University”, payable atJalandhar.

Modular Flexi-learningProgramme

5-Pronged Advantages

Clinical Research at Fast Track

CR@FT not only

makes the students

industry-ready but

also helps them

upgrade their

qualifications and

skills while working.

IT Enabled

Anovus provides training on one of world's

best Clinical Research softwares, SAS. The

students learn the use of powerful and

sophisticated statistical tool techniques for

planning and analysis of clinical research

experiments and investigations as an essential

component of the curriculum. The students

can also acquire the much-in-demand

International SAS Certification.

Managerial Skills

Anovus lays great emphasis on the overall

development of the student. Therefore, a

module on management skills is imparted

which includes interactive seminars on

language and communication skills,

personality enhancement, interpersonal skills,

etc.

Industry-backed

University Recognized Programs

The course curriculum at Anovus has been

formed with elaborate combined efforts of

the academia and the industry. Specific

inputs have been incorporated from various

organizations including pharmaceutical,

manufacturing, research, contract research,

IT, healthcare and regulatory affairs.

Practical Training

Students are exposed to centres where

clinical trials are performed/professionals

involved in clinical trials. Also, to give them

first-hand understanding of the trial process,

practical training is imparted through

simulated clinical trials.

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CRAFT at Anovus has five distinct advantagesfor the students pursuing clinical research.

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Anovus Modular Programme andCareer Growth Opportunities

Diploma (6 Months)You can Start Here

Advance Diploma (1 Year)

M.Sc.(2 Years)

Job

Lateral Entry(6 months)

Lateral Entry(with break)

Lateral Entry(1-1/2 years)

Lateral Entry(1 year)

La

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(1

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You can Start Here

You can Start Here

Modular Flexi-learningProgramme

The students can opt for direct admission to

any of the programmes or follow the modular

method and continue to upgrade his/her

qualification and achieve certification. The

student can later join the next level, with or

without a break, by paying the applicable fee

(depending on the availability of seats)*.

Clinical Research at Fast Track

*Students enrolled in a higher course will not be eligiblefor lower certification under any circumstances.

Admission Procedure

StudentInformation

Please read the

rules and procedure

details carefully

before applying.

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andidates need to fill in the

application form (enclosed with the Cprospectus), after confirming their

eligibility as per the eligibility criteria. Please

enclose all required attachments.

Selection Procedure

To maintain high academic standard, the

Institute gives due importance to the quality of

students enrolled. To ensure this, each

individual student will undergo the following

admission procedure:

Online Test

An MCQ based Science and General

Awareness test will be conducted to

determine suitability of the candidate. The test

will be of +2 level.

Personal interview

After qualifying the test, a personal interview

will be conducted to assess candidate’s

suitability to the programme.

The number of seats for each programme are

limited. Admission to the eligible students will

be granted on “First-come-First-Served” basis

as per the receipt of first schedule of fees.

THERE ARE NO MANAGEMENT SEATS

The decision of the Institute to confirm or

refuse admission will be final.

Education Loan

Anovus is in contact with Bank of Rajasthan

Ltd to facilitate educational loan for the

students.

Student ID

On grant of provisional admission to the

programme by the Institute, each student

shall be allotted a unique Student

Identification Number (SID) and all

correspondence with the Institute should

bear the same.

With Pharma multinationals under cost pressure, outsourcing of Clinical

Research to high quality-lower cost destination is gaining momentum. India is

well suited to garner a major share of this multibillion dollar market. With the

syllabi having right balance of Technical, Soft and IT Skills, Anovus with its

competent faculty is well positioned to deliver Industry Ready manpower.

Arvind Vasudeva Managing Director, RPG Life sciences

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Campus Activities

Industry-AcademicPartnership

Dr. Girish SahniDirector IMTECH was recognized with an award of Excellence for the development of life saving clot buster molecule. He spoke on drug development and importance of clinical research on the occasion.

Mr. Anil KohliPresident Business Development, Surya Pharmaceuticals Ltd. spoke on Indian Pharmaceutical industry, the process of drug development and the role played by clinical research in meeting health issues.

Dr. Sanjay TrehanSenior Vice-President, Panacea Biotec Ltd. spoke on the growing areas of drug discovery to the new batch of clinical research student at Anovus.

Mr. Maneet SinghPresident, ADI Backoffice Professionals, (P) Ltd., &Director, ADI Bestvalue UK Ltd. shared his experiences on the use of IT in drug development.

Mrs. A. RajeshwariRegulatory Lead Biological E. Limited. explained the process of regulatory submission in Clinical Trials.

n the past few months, Anovus Institute of

Clinical Research has organised a series of

seminars, workshops and lecture series for Isharing the opportunities in clinical research

amongst the academicians, students,

professionals, pharmaceutical and health

industries.

Seminars on ‘Global Opportunities in Clinical

Research’ and ‘Careers: Think Beyond

Tradition’ were held in over 40 educational

campuses with more than 3500 students in

attendance.

Anovus intends to organise a national

conference on clinical research in Chandigarh.

Lecture series are planned by inviting various

senior professionals and industry leaders from

pharma, health care and clinical research

domains to interact with the students.

KnowledgeSeries

Training& Placement

Training

Anovus has a strong industry backing to

facilitate hands-on training and internship to

its students in some of the leading pharma,

health care and clinical research

organisations.

Placements

n100% Placement Assistance

nTraining Focussed on Employability

nAnovus has tie ups with various

organizations in field of Health care,

Pharmaceuticals, Clinical Research and

IT (clinical trials data management) for

assisting in placement and careers in

clinical research industry.

Anovus Clinical Research,

a site management

organisation (SMO),

is undertaking clinical

trials in the region

giving some of our

students an opportunity

of hands-on experience

on live assignments.

For more information

www.AnovusCR.com

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Chandigarh The Seat of Learning

Chandigarh is the most popular destination for national

and international events, not only because of its excellent

infrastructure, but also for a wide variety of tourist

attraction that the city boasts of. Right from

landmark architectural creations of Le Corbusier

to the shopping malls, multiplexes, wide open

avenues, Sukhna Lake, and the world-famous

Rock Garden. The city today is also the seat of

three state governments and is a popular

destination for the students to pursue further

studies in excellent

learning environment

supported by a robust

infrastructure.

Lecture Campus

Plot 28-29, Opposite Batra Theatre

Dakshin Marg, Sector 24C, Chandigarh 160 036 India

Contact : 09023996160, 09814000720

[email protected]

www.anovus.net

Anovus Institute of Clinical Research An Initiative of

Hit Abhilashi Foundation