A Clinical Research Site Management Organization as well as Clinical Research Training Institute

What is Clinical Research/Trial?

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other
pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an
investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an
investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial
and clinical research are synonymous.

In short Clinical research is a branch of medical science that determines the safety and effectiveness of
medications, devices, diagnostic products and treatment regimens intended for human use. These may be
used for prevention, treatment, diagnosis or for relieving symptoms of a disease.

Why Clinical Research?

Clinical Research look at new ways to prevent, detect or treat disease. Treatments might be new drugs or
new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The
goal of clinical research is to determine if a new test or treatment works and is safe.

Clinical Research is an important step in discovering new treatments for diseases as well as new ways to
detect, diagnose, and reduce the risk of disease. Clinical trials show researchers what does and doesnt work
in people. Clinical trials also help researchers and doctors decide if the side effects of a new treatment are
acceptable when weighed against the benefits offered by the new treatment.

From Laboratory to Market:

A medicine starts out as a new drug molecule which, after many years of basic research, has emerged as a
potential treatment for a particular disease. To put this in to context, consider that of 10,000 new promising
drug molecule, if 1 makes it to the first stage of clinical trial, the R&D department are doing so well. The new
drug molecule then must go many years of clinical development, and must fulfil many criteria before
eventually being approved for use as a medicine.

Developing a drug can take up to 15 years and cost
can run in to billions of dollars.


Developing a drug can take up to 15 years
& the cost can run in to billions of
Dollars!!!

A Clinical Research Site Management Organization as well as Clinical Research Training Institute

Clinical Research Phases:

Before a new drug can be tested in people, it must undergo rigorous pre-clinical testing both in-vitro and in
suitable animal model, also known as Pre-Clinical Phase. During this phase important pharmacological data
are obtained about drug dosing, and potential hazards and risks are identified. This allows regulatory
authorities to make a risk assessment and consider the drugs suitability for testing in humans.

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval
process is treated as a separate clinical trial. The drug-development process will normally proceed through
all four phases over many years. If the drug successfully passes through Phases 1, 2, and 3, it will usually be
approved by the national regulatory authority for use in the general population.


Clinical Research Process

Animal &/or
Laboratory
Studies


About
4 years

Phase I

15-30
Patients

Phase II

Fewer than 100
patients

About
8-9 years

Phase III

100s to 1000s
of patients


Regulatory
Approval

Phase IV
Drug is in the
market but still
long term
safety &
efficacy need to
check


Clinical Research in India:

Indian Clinical research Industry was estimated at US$ 50 million in 2003, US$ 200 million in 2008 & US$
1000 million in 2010. Clinical Research staff requirement was 800 in 2003, 4000 in 2008 & 20,000 in 2010. As
per Mckinsey Report India is expected to reach US$ 6000 million by 2015 which indicates need of 60,000-
80,000 expertise in 2-3 years in Clinical Research Field.
India is attracting collaborative contract proposals for conducting clinical research and many entrepreneurs
have already come forward to set up their Clinical Research Organizations (CRO) due to:

Larger patient pool
Highest patient recruitment rate
Least expensive (Cost to conduct clinical trial in India is 50-60%lower as compared to US/UK/EU)
Highest Investigator and facility pool
Most conductive Regulatory Environment
Quality of data is acceptable to US/UK/EU
Availability of Medical, Pharmacy & Science graduates





A Clinical Research Site Management Organization as well as Clinical Research Training Institute

Percent of Global Trials done in India:



Demand & Supply gap in India:

If Indias clinical trial business grows to 10% of the scope seen in the U.S. by 2015, then the industry will
need approximately 70,000 recruits. India has a huge pool of scientific, pharmaceutical, and medical talent,
but the supply of trained professionals in India is approximately one-tenth of its demand. Unless research
training institutes are established, this huge gap between the demand and supply of trained personnel
cannot be bridged.



Other site staff 4000
400


Investigator 2000
300


CRO Staff 6000
1000


Sponsor Staff 1000
200


0 1000 2000 3000 4000 5000 6000 7000
Demand
Supply

A Clinical Research Site Management Organization as well as Clinical Research Training Institute

Clinical Research Career Pathways:

Pharmaceutical Companies
Clinical CROs (Contract Research Organizations)
BA/BE Centers
SMOs (Site Management Organizations)
AROs (Academic Research Organizations)
Data Management CROs
IT Companies in Healthcare / Clinical Domain
EDC Service Providers
Central Laboratories
Investigator & Site Staff
Training Centers

Careers in Pharmaceutical Company/ Careers in SMO/ARO
CRO/Biotech Companies














Careers in Clinical Data Management Careers in BA/BE Centres








Clinical Trial Assistant (CTA)
Clinical Research Associate (CRA)
Senior CRA
Clinical Team Leader
Project Manager
Senior Project Manager
Pharmacovigilance (PV)
Manager Medical & Regulatory
Manager Safety / Patents
Manager Quality Assurance
Medical Director
Associate Director Clinical
Associate Director Projects
DirectorBusiness Development
Director / Head (Clinical Operations)
General Manger / CEO / President
Clinical Research Coordinators (CRC) /
Trial Coordinators
Principal Investigators / Co-Investigators
Medical Monitors
Project Manager / Senior Project Manager
Manager Medical & Regulatory
Manager Quality Assurance
Manager Business Development
Medical Director
Associate Director -Clinical
Associate Director Projects
Director / Head (Clinical Operations)
General Manger / CEO / President

Data Entry Operator
Data Validation Executive
QA Executive
Data Manager
QA Manager
Statistical Programmer
Statistician
Data Reviewer
Data Base Designer
Medical Writer
Head Data Management
Clinical Research Associate (CRA)
Project Manager
Manager -Medical & Regulatory
Manager Safety / Patents
Manager Quality Assurance
Laboratory Technicians / Head(s)
Statisticians
Medical Writer
Medical Director
Business Development Manager
Director / Head / CEO

A Clinical Research Site Management Organization as well as Clinical Research Training Institute

Career in IT Companies/EDC Service Career in Training Institutes
Provider












Salary in Clinical Research:

Position Annual Salary in Rupees (INR)
CTA/CRC/DEO (0-1) 2,40,000 3,60,000
CRA/Data Coordinator/PV Associate/ Medical
writing (1-2)
3,60,000 4,50,000
Senior CRA/Regional CRA (2-3) 4,50,000 6,00,000
Project Manager/Data Manager (3-5) 6,00,000 7,20,000
Quality Assurance (3-5) 7,20,000 8,00,000
Regulatory Affairs (3-5) 8,00,000 9,00,000

About Mojidra Research:

Mojidra Research is Clinical Research Site Management Organization (SMO) as well as Clinical
Research training Institute. We provide end to end solutions to the pharmaceutical, Biotech and
Clinical Research Organizations.

Advantage of Mojidra Research: Mojidra Research is a SMO as well as Clinical Research Training
institute. So we have close link with the clinical research industry. We provide 100% placement
assistant to all students. We run various courses on Clinical Research, Data Management,
Pharmacovigilance and Regulatory Affairs. (Full-time as well as Part-time)
Eligibility Criteria:
Health science: B.Pharm, M.Pharm, BHMS, BAMS, BUMS, BVSc, Bpt, BSc. Nursing, MBBS, BDS
Life Sciences: BSc. MSc. - Biotechnology, Microbiology, Chemistry, Botany, Zoology, Bioinformatics,

Domain Consultant
Oracle Programmer
Data Reviewer
Data Base Designer
SAS / Statistical Programmer
Project Manager
Validation Executive / Manager
QA Executive / Manager
Statistician
EDC Trainers
Business Development
Head Healthcare / Life sciences

Lecturer / Trainer
Associate Professor /Professor
Clinical Trial Management
Data Management
Pharmacovigilance
GCP, Regulation
Project Management
Project Finance
Logistics
Training Coordinators
Training Director


A Clinical Research Site Management Organization as well as Clinical Research Training Institute

Classroom Courses at Mojidra Research:
1) Clinical Research Course (Full-Time):

Duration: 9 Months (6 Months classroom & 3 Months training in Clinical Research)

In this course student can also work as a Study Start-up Specialist at Mojidra Research (SMO) during 6
Months Classroom training (During this time student will get salary up to 10,000 Rupees/Month). So at the
end of the course student will receive Clinical Research Course Certificate, Experience Letter of 6 Months
from Mojidra Research & Experience Letter of 3 Months from Clinical Research Company/Hospital.

2) Clinical Research Course (Full-Time):

Duration: 6 Months (4 Months classroom & 2 Months training in Clinical Research)

3) Clinical Research Course (Fast-Track):

Duration: 4 Months (4 Months classroom training)

4) Clinical Research & Data Management Course (Full-Time):

Duration: 6 Months (5 Months classroom & 1 month Practical training)

5) Clinical Data Management Course:

Duration: 4 Months (3 Months classroom training & 1 month Practical Training)

6) Clinical Research & Pharmacovigilance Course:

Duration: 6 Months (6 Months classroom training)

7) Pharmacovigilance Course:

Duration: 3 Months (3 Months classroom training)

8) Clinical Research & Regulatory Affairs Course (Full-Time):

Duration: 6 Months (6 Months classroom training)

9) Regulatory Affairs Course:

Duration: 3 Months (3 Months classroom training)

A Clinical Research Site Management Organization as well as Clinical Research Training Institute


Online Courses at Mojidra Research:

1) Clinical Research Course

Method: Online Training

Examination: Online Multiples Choice Question (MCQs)

In this course student will be provided additional documents (of a clinical trial) to develop practical
skills. These documents are of Investigator Site File (ISF) and through these documents students will
learn:
How a patient is identified for trial
How patient is recruited in the trial
What are the procedures carried out by the Investigative site team
How the data are collected
How the data are recorded
How the data are transcribe in to CRF
How to report safety issues of clinical trial
How to monitor/audit a clinical trial
Audit trail
Upon successfully completion of course student will get Clinical Research course certificate.

ICH-GCP online Training will be provided followed by ICH-GCP Online Examination. Candidates
successfully completed ICH-GCP examination will get ICH-GCP Certificate. ICH-GCP certificate is a
mandatory document for all clinical research professionals.

2) Clinical Research & Data Management Course

3) Clinical Data Management Course:

4) Clinical Research & Pharmacovigilance Course:

5) Pharmacovigilance Course:

6) Clinical Research and Regulatory Affairs Course:

7) Regulatory Affairs Course:

A Clinical Research Site Management Organization as well as Clinical Research Training Institute


8) Clinical Research Practical Course:

9) ICH-GCP Online Training:

Placement:
100%Placement assistant will be provided to all students. There are some options for placement:
Mojidra Research is a Clinical Research Site Management Organization (SMO), so potential students
will be directly recruited by Mojidra Research
There are chances that student will be recruited at the Clinical Research Company/Hospital where
he/she will be placed for practical training
Mojidra Research has a close link with the Clinical Research Industry (Masters in Clinical Research
from Cranfield University (UK) & 5 Years of experience in clinical research (UK as well as India)
Campus interviews will be arranged from Clinical Research Industry



For Details Contact:
Mr. Chintan Mojidra
Email: [email protected]
Mobile: 9662344009; 9825656899
Office: 079 25454904


Mojidra Research
903-904 P.B. Parekh Tower
Opp. Vanijya Bhavan
Diwanballubhai Road
Kankaria, Ahmedabad 380022
Gujarat, India
Url: www.mojidraresearch.com






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