PARR 2

Today we will be learning about:

• What is Drug Development process?

• What is Clinical Research?
• How is Clinical Research relevant in a Drug
Development process?
• What are the careers involved in Clinical Research?
• The stability of Clinical Research Industry and
rewards involved.

I am sure you will appreciate the importance of numerous

drugs and the role they play in our day-to-day life. All
problems require a solution. In the health care-industry,
problem means a “disease”, and this problem requires a
solution in the form of a medicine. This medicine or drug
is developed after a molecule goes through various stages
under drug development process.

You being a Clinical Research aspirant, it adds value to

know the drug development process and the role of clinical
research process in drug development process.

Study the graphical representation of the drug development

process:
Pharmaceutical companies produce medicines after an
extensive research, which is carried out in various stages.
The stages can be broadly termed as Drug Discovery, Pre-
Clinical, and Clinical Research processes.

Drug Discovery Process:

In medicine, biotechnology or pharmacology, drug discovery

is the process by which drugs are discovered and/or
designed.

• The process of Drug Development starts with having

certainty on the field of medicine that the
pharmaceutical company selects. For e.g. Dermatology.
• After the selection of the field or area, the right
lead compound or target identification from the
library (earlier produced for future research by the
researchers) is determined.
• This results in the synthesis of this lead compound
chemically.
 • Then the chemically synthesized molecules are tested
for its potential effects using computers and 3D
structure activity relationship.
• Hereafter, the potential molecule (also known as
Investigational product, or New Chemical Entity) that
is determined will go to the pre-clinical testing
(which is performed on animal).

Pre-Clinical process:

Pre-Clinical tests are the tests conducted on animals to

establish safety and efficacy of the NCE in animals before
the clinical testing (testing in humans) is initiated.

• Pre-Clinical testing is conducted on various species

of rodents and non-rodents.
• Testing is carried out for different duration for
extended studies on safety and efficacy.
• Then toxicity, mutagenicity and carcinogenicity
studies are carried out to check if there is any
associated impairment with the long-term use of the
NCE.
• Once the effects are found to be safe and effective in
animals, then the NCE is manufactured in small-scale
in order to perform clinical trials. This is because
the molecule should be used in human beings in a
particular dosage form (like tablet, capsule, etc)

Clinical Research process:

What is Clinical Research?

Clinical Research can be defined as trials that evaluate
new drugs, biologicals, or medical devices on human beings
in strictly, scientifically controlled settings, in order
to establish the safety and efficacy of the experimental
therapy.

• After development of the dosage form, the

Investigational New Drug (IND) is given as a tablet,
capsule, etc for Clinical Research.
• Clinical Research is an important part of drug
development as all drugs that are discovered should be
finally beneficial to human beings. Therefore, this is
the stage where efficacy and safety of the molecule
should be proved.
 • To start, the investigational product gets tested on
20-80 healthy human volunteers depending on the type
of study, this stage is called Phase I.
• Once the regulatory department approves the results
from these tests, the investigational product gets
into Phase II. The IND is tested on 100-400 patients
in this stage.
• Again after approval from the regulatory department on
Phase II results, the investigational drug goes for
Phase III testing, which involves 500-10,000 patients.
• The IND is then launched into the market on approval
from the regulatory board.
• After the launch there is post marketing surveillance
performed to ensure that there are no ill affects of
the drug in the long run. This stage is called Phase
IV.

Insight into Clinical Research:

• Clinical Research is an evergreen field, which

requires skilled/trained life science personnel. Thus
it is here to stay in India.
• Apart from the research on new drugs (allopathic) that
are developed for the various diseases, the new burst
in the ayurvedic, genetic, biotechnology and medical
devices related research springs more opportunities.
This new extension ensures greater stability both in
clinical operations, clinical data management, medical
writing and other fields within clinical research.
• Apart from the benefits of these developments there is
a great demand for the generic drugs that are being
brought into the market from various companies.
• So there are both innovator drugs and generic drugs
that are undergoing various trials all around the
world.
• About 10%-15 % of the study population for all trials
is Indians and due to the pool of patients and the
right medical facility, the Indian contribution into
clinical research is continuously increasing.

Careers in Clinical Research:

Here, we would go through the various positions available

in clinical research industry. We will assist you to decide
as to what job profile suits you or you can choose based on
your interest. Some of the positions available in the field
of clinical research include:
 • Bioanalytical Positions
• Business Development
• Project Management
• Quality Control
• Research Scientist
• Bioinformatics
• Clinical Data/Archives
• Regulatory Affairs
• Biostatistician
• Clinical Research Associate
• Clinical Data management executive
• Marketing/Public Relation
• Technician, Skilled Trades
• Medical Writing
• Clinical Research Coordinator
• Clinical Research Investigator and the list continues.

As the phases of Clinical Research progresses from one

phase to another, there is a requirement for skilled
professionals for trials and documentation. The industry is
open to provide lots of opportunities for trained/
certified professionals in various areas such as, Clinical
Operations, Site Operations, Clinical Data Management
Operations, Medical Writing and much more.

The employers of the industry are looking for trained

professionals who have the overall knowledge of industry
process.

Additionally, students are trained on the following topics

in CliniLead I of Certified Clinical Research Professional
(CCRP) course:

1. History of Clinical Research: Takes you through how

clinical research started and emerged through to the
present standards.
2. Drug Development Process: Explains how a molecule gets
isolated from a source, purification process till it
reaches the market.
3. Pre-clinical Development: Explains how the drug gets
tested on animals. The various stages of pre-clinical
development that are mutagenicity, toxicity testing,
etc. is discussed in detail.
4. Bioavailability and Bioequivalence (BA-BE): Elaborates
on BA-BE studies, which forms a major share of the
Clinical Research business in India.
 5. Essential clinical trial documents: Provides you with
a list of mandatory documents like protocol,
investigator brochure (IB), informed consent document,
Investigational product Accountability … etc for a
Clinical Research study.
6. Clinical Development: You will learn about all the
phases of clinical research in detail.

Today we will be discussing regarding:

• Why are ethics necessary in Clinical Research?

• How the knowledge on ethics in Clinical Research helps
you throughout your career in the industry?
• What are the regulations followed in Clinical
Research?
• Why is it mandatory for a professional in Clinical
Research to understand the ethics and regulations?

Now let us start with understanding the first question and

thereon with history behind each statement/question:

It is mandatory that all the Clinical Research

professionals should understand the rules; regulations, and
guidelines that govern clinical research internationally.
Please go through the trial carried out in USA before
specific guidelines (Good Clinical Practice) was set in
place and decide for yourself if what happened was ethical
or not!

The Tuskegee Syphilis Experiment:

(Reference:
http://www.infoplease.com/spot/bhmtuskegee1.html)

Syphilis (sif' u lis) contagious sexually transmitted

disease caused by the spirochete Treponema pallidum

For forty years between 1932 and 1972, the U.S. Public
Health Service (PHS) conducted an experiment on 399 black
men who were in the late stage of syphilis. This study
became abusive because it was conducted without any care to
its subjects, and led to major changes in how patients are
protected in clinical studies. Individuals enrolled in the
Tuskegee Syphilis Study were not asked to give informed
consent and were not informed of their diagnosis; instead
were told they had "bad blood" and could receive “free
treatment, a free ride to the clinic, one hot meal per
day”, and, in the event of death, $35 (later raised to $50)
for the funeral. They were informed that they were being
treated for “bad blood,” their doctors had no intention of
curing them of syphilis at all.

The data for the experiment was to be collected from

autopsies of the men, and the subjects were thus
deliberately left to degenerate under the ravages of
tertiary syphilis— which can include tumors, heart disease,
paralysis, blindness, insanity, and death. “As I see it,”
one of the doctors involved explained, “we have no further
interest in these patients until they die.”

One of the most chilling fact of this experiment was how

zealously the PHS kept these men from receiving treatment.
When several nationwide campaigns to eradicate venereal
disease came to Macon County, the men were prevented from
participating in it. Even when penicillin—the first actual
cure for syphilis—was discovered in the 1940s, the Tuskegee
men were deliberately denied the medication.

The aftershocks of this study led directly to the

establishment of the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research and
the National Research Act. This act requires the
establishment of Institutional Review Boards (IRBs) at
institutions receiving federal grants. Special
consideration must be given to ethnic minorities and
vulnerable groups in the design of clinical studies.

There were many more studies conducted that were unethical

and unregulated, which resulted in human exploitation.

Hence, in other words,

Clinical Trials + Human Beings = Potential for human

exploitation

Thus it is mandatory to set ethical standards added with a

central body which regulates clinical research carefully.

Q ) Which is important? Is it Regulatory body or ethical

body?

Ans ) It is clearly evident that both the ethical bodies

and regulatory bodies are important in order to run proper
clinical research trails. The ethical parameters set by an
ethical body provides ethical guidelines, which is common
to all the trials. The regulatory bodies can avoid
unethical practices as well as take legal action on
personnel involved in improper trials.

It is mandatory that all the Clinical Research

professionals should understand the rules; regulations and
guidelines that govern clinical research internationally
and in their respective countries.

The International Conference of Harmonization (ICH) is a

unique international body that's entrusted with making and
updating guidelines that bring together the regulatory
authorities of Europe, Japan, Canada and the United States.
The purpose of this regulation is to achieve greater
harmonization in the interpretation and application of
technical guidelines and requirements for product
registration in order to reduce or eliminate the need to
duplicate testing carried out during the research and
development of new medicines. The objective of such
harmonization is a more ethical and economical use of
human, animal and material resources and the elimination of
unnecessary delay in launching the same molecule globally
while maintaining the safety, efficacy, quality and
regulatory obligations of all countries.

What is GCP?

Good Clinical Practice (GCP) is an international ethical

and scientific quality standard for designing, conducting,
recording and reporting trials that involve human subjects.

Compliance with GCP ensures that the rights, safety and

well being of the subjects are protected and that the
clinical trial data are credible. These principles have
their origin in the Declaration of Helsinki.

The Declaration of Helsinki gives a strong directive on how

medical research should be conducted in human beings. This
declaration binds all medical researchers to the ethical
principles mentioned in the declaration.

Thus following ICH-GCP guidelines (which is an unified

standard for US, EU, Japan and Canada) the data generated
from the GCP compliant clinical trial will be accepted by
the regulatory bodies of all countries that are members of
the ICH-GCP council.
Any Clinical Research aspirant who has good knowledge of
the ICH-GCP and Schedule Y will be a strong contender to
Clinical Research Industry. With this requisite knowledge
in Regulations and GCP all aspirants will have a very
bright future in Clinical Research and can be a part of
international Clinical Trials (CT).

Given below are the 13 The Principles of ICH-GCP for your

reference:
CT - Clinical Trials; QA - Quality Assurance; QC - Quality
Control; IEC - Institutional Ethics Committee; IRB -
Institutional Review Board; ICH-GCP - International
Committee of Harmonization- Good Clinical Practice
DCGI (Drug Control General of India) controls all the
aspects of Clinical Trials and approvals of the medicines
in India.

Schedule Y:

Schedule Y deals with regulations relating to clinical

trial requirements for import, manufacture and obtaining
marketing approval for a new drug in India.

Schedule Y contains the forms that need to be used and the

data that needs to be collected, as the Investigational
product moves from one phase to the other. It also contains
the essential clinical trial documents for the trial
conducted in India., etc.

You will be learning in detail about the International

ethical standards (GCP), Schedule Y, and other ethical and
regulatory aspects in Clinilead – II of CCRP

The other topics that you will be learning in CliniLead II

are:

• Essential Clinical Research Terminology

• Pre-requisites of the study
• Ethical and Safety considerations
• Responsibilities of EC
• Responsibilities of Sponsor
• Responsibilities of Monitor
• Responsibilities of Investigator
• Record keeping and data handling
• Documentation process
• Special concerns
• Clinical trial of vaccines and phases
• Clinical trial of contraceptives
• Clinical trial of medical devices
• Clinical trial of diagnostic agents
• Clinical trial of herbal remedies
• Formats for CT submissions to DCGI
• Schedule Y
• Regulations in US, Europe and Australia

Today we will be learning:

 • What is an organization? How did it come into being?
• Services provided by CRO's.
• Organizational structure - Clinical Operation and Data
Management
• An insight into the organizational skills, which
accelerates your career growth.

What is an Organization?

The word “organization” is derived from the Greek word

organon, which means ‘a tool'. The term is used in both
daily and scientific English in multiple ways.

Meaning: The very basic meaning of organization is

'Arrangement'. Organization in terms of career is a group
of people intentionally organized to accomplish an overall,
common goal or set of goals.

( Carter McNamara, MBA, PhD, Authenticity Consulting, LLC )

As a famous author, John Donne, has written, ‘No man is an

Island'. It is difficult for a single person to function at
the optimum when alone. He is at his best when around
people. Increased manpower means increased business, and
vice versa. This is the main reason for the formation of
organizations.

For optimal functioning in the field of medical research,

Contract Research Organizations (CRO) came into existence.

GCP defines the Contract Research Organization (CRO) as an

organization to which the sponsor may transfer or delegate
some or all of the tasks, duties and / or obligations
regarding a Clinical Study.

Stan W. Woollen, Associate Director for Bioresearch

Monitoring from the Office for Good Clinical Practice
defines a Site Management Organization (SMO) as a person/
organization that assumes, as an independent contractor
with the clinical investigator, one or more of the
regulatory obligations of a clinical investigator, e.g.,
preparation and maintenance of case histories, ensuring
compliance with IRB review.

There are a number of positions that are available in a CRO

and SMO. Take a look at the diagram given below. This shows
the various departments in the CRO or the departments that
the CRO interacts with at regular intervals.

Various departments in CRO industry are as follows:

• Medical Writing
• Quality control and assurance
• Regulatory affairs
• Medical monitoring
• Pharmacovigilance
• Diagnostic imaging services
• Data management
• Analytical department
• Final report writing

They are constantly in touch with the following bodies:

• Data and Safety Management Board

• Regulatory Body (US FDA, DCGI, etc)
 • Central laboratory for biological samples.

The basic organizational model of a CRO is as given below:

Basic operational model for Data Management is as given

below.
The higher the position you are in, the better you need to
be at your organizational skills.

Therefore with right organizational skills, you will be

what you want to be in an organization. Gaining the
organizational skills not only improves your performance in
your designated role, but also triggers a progressive
career path.

For instance, let's learn about email writing.

Email Etiquette: - the very basics are to convey a message

in clear and concise tone. This is the basic thing that one
should know to convey information in an organization setup.

The fist question you need to know before write an email is

WHY are you writing. The answer becomes the very first
sentence. The reader gets the message in the very first
line. The reader is no more searching for the context! A
little more in detail:

Correspondence often has a 3-part structure. A simple way

to signal this structure to the reader is to use 3
paragraphs, one for each part of the structure.

This 3-part structure will encourage you to write short,

concise letters. For example:
Paragraph 1: - Introduction.

It usually deals with the past. It says why the letter has
been written.

Paragraph 2: - Development phase.

Updates the reader on the matter and explains the current

status of matter. In complex letters this section may be 2
or 3 paragraphs.

Paragraph 3 is the conclusion or outcome.

It foresees a problem or the solution to the existing

problem and focuses on action.

Take a look at the example provided below:

Through the Certified Clinical Research Professional course
(CCRP), you would also be learning:

• Problem Solving Skills

• Communication skills
• Email communication
• Art of questioning
• Attention to Details
• Minutes of the meeting
• Time Management Skills
• Telephone Etiquettes
• Presentation Skills
• Interpersonal Skills - Being a team Player
• Documentation skills
• Participating in the meetings
• Career skills

The above skills are handpicked after consulting the

leaders in the industry for the desired skills they are
looking at. Learn them and you have an edge – Guaranteed!

Next, in the final part-5 of this online course brings to

you a recap of the previous four parts followed by a pre-
test which qualifies you to take up CCRP certification.

Do remember that the CCRP course is designed for the

industry needs. The goal of InLeaD is to train you to the
industry standards. Be prepared to get certified. Our
placement cell supports you until you succeed.

Overview of Clinical Research and Careers - Part

5
Thank you for taking this online training course

Greetings from InLeaD (Institute for Learning and

Development).

Part 5 takes you back to the history - a recap about the

previous 4 parts followed by a simple pre-test which
qualifies you to take up CCRP certification.

Just a re-visit to understand the demand of the industry

and the need to be trained now:
 • An estimated 100,000+ clinical trials are carried out throughout the world.
Thousands of trials are conducted in India.
• CRO's, Pharmaceutical companies, Hospitals and biotech companies need trained
professionals to monitor and manage clinical trials.

You will learn the core skills through CCRP course. This can enable you to contribute to
the research and allied services teams finding medicals solutions for problems faced by
the mankind.

What you have achieved till now:

Congratulations you are on the verge of completing the step 1 (this course which you
have studied over a week)

• Now you have studied regarding the various processes

involved in Clinical Trials and drug development
process.
• You have understood the fundamentals of GCP,
principles of GCP and regulatory bodies.
• You can appreciate the importance of Organizational
skills and the role it can play in your career.
• It is now the time to build on the knowledge you have
gained. You are one among the special few to enroll
and learn the online course. Answer a simple pretest
and you become eligible to the full course- the CCRP.
CCRP course is offered only to the select few who have
the urge to study and gain the industry knowledge.
Enroll now and complete the CCRP full course.

That's exactly what the industry needs!

Now is the right time! Yes, the Clinical Research Industry

is booming. This growing stage of the industry always
provides great career opportunities and growth at a good
pace.

• Now that you have completed the free short course in

clinical research, Please open the pretest(word.doc),
answer and send the soft copy to ccrp@crocareers.in

** Download the Pre-test here. Click here.

• CCRP is an intensive, industry-recognized course,

which enables you as a potential candidate for the
Clinical Research Industry and assists you in the
selection process.
• Once you have completed the course, you get certified
and your CCRP qualified resume is uploaded on to our
 web site www.crocareers.in. The list of Clinical
Research Employers seeking CCRP's is growing day by
day!
• Additionally, we strongly promote your profile through
our network of placement consultants and assist you in
choosing the right career.

All you need now is a good training. Once you get

recognized as a Certified Clinical Research Professional
(CCRP), you are just not trained but also viewed by top
employers.CCRP course training is flexible and suits your
day-to day activities. Be a better contender for an
exciting Clinical Research position in just 6 weeks!

All you have to do is follow the steps below:

First: Please mail the answered pretest to Mail-id:

ccrp@crocareers.in

Second: Join the CCRP course.