Job opportunities after completing Clinical Research Course

Introduction to Clinical Research

It is a well-known fact that for overall career growth; right education, acquiring practical knowledge and developing a right attitude is of immense importance especially in specialized industries such as clinical research. Clinical research defines the entire profile of a drug or any newly fabricated medical devices, tracking its development right from its inception in the research centre to the consumer market and beyond. The recorded history of clinical trials goes back to the biblical descriptions in 500 BC.[1] The drug development and medical device industry has observed a remarkable evolution over the decades. Due to a paradigm shifting change in the field of biotechnology and pharmaceuticals, companies have gained momentum in developing highly unique and safe medical devices and drug molecules.

What happens in Clinical Research

The new molecule or device is subjected to pre-clinical and clinical trials before entering the market, which is later followed by post-marketing surveillance. Pre-clinical studies consist of studying and analysing the effects and side-effects the drug has on animals, that generally comprises of carcinogenicity, teratogenicity and toxicological studies. The successful pre-clinical studies call for an Investigational drug application (INDA) to take permission for human studies, to mark it eligible to conduct clinical trials (four phases) in human population.[2]

Types of Clinical Research

Based on study design, there are two main types of clinical trials, Observational and

Interventional study:

The U.S. Food and Drug Administration (FDA) and its corollary agencies abroad have classified four phases that needs to be administered during a clinical trial: [2]

Phase I trials:

• Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
• Length of Study: Several months
•  Purpose: Safety and dosage
  

Phase II trials:

•  Study Participants: Up to several hundred people with the disease/condition.
• Length of Study: Several months to 2 years
•  Purpose: Efficacy and side effects
  

Phase III trials:

• Study Participants: 300 to 3,000 volunteers who have the disease or condition.
• Length of Study: 1 to 4 years
• Purpose: Efficacy and monitoring of adverse reactions
  

Phase IV trials: 

•  Study Participants: Several thousand volunteers who have the disease/condition.
•  Purpose: Safety and efficacy
  

Market value of Clinical research

In the year 2017, the market size of Indian clinical trials was valued to be around USD 1.6 billion. It is likely to develop with a growth rate of 8.7% by the year 2025. India has been ranked second (after China) in terms of patient population for clinical trials. To add on, the low cost of clinical trials in India in comparison to United States of America and Europe is an important aspect to drive the market growth. [3]

Importance of Clinical Research

Clinical trials not only provide the masses with information about an upcoming blockbuster drug but can also shed valuable information on the benefits and safety of existing therapies, providing reliable information for doctors and patients to choose between alternative therapies.

Finally, since "to ensure their safety and efficacy, any drug or medical device must be thoroughly examined through closely monitored and highly regulated clinical trials," patients receiving medical attention should be encouraged to participate in clinical trials.

Clinical trials benefit the scientist the most, since it makes clear whether or not a drug will ever be suitable for human applications. Clinical trials also help doctors decide whether, when weighed against the potential benefits, the side effects of a new treatment are acceptable.

Only in the rarest of cases does a patient get affected by a drug or during a clinical trial procedure. Yet it is praiseworthy to note that millions of people are benefited because other people before them chose to participate in a study that resulted in a new, more effective treatment.

Why a career in Clinical Research?

The entire process (as mentioned above) is aided by pharmaceutical firms and a large number of expanding clinical trial management organizations including contract research organizations (CROs), site management organizations (SMOs), clinical data management, knowledge process outsourcing (KPOs), investigator and site staff, etc. These organizations demand competent and skilled work force in the clinical research industry.

The major clinical research companies in the area are Biocon, GlaxoSmithKline, Johnson & Johnson, Astra Zeneca, Ranbaxy Laboratories, Nicholas Piramal, Pfizer etc.

In the field of CROs, the key players are Quintiles, ICON International, Inc., Clintec, Accenture, Parexel etc.

Job roles in CROs / Pharma / Biotech Companies [4]

•  Clinical Trial Assistant (CTA)
•  Clinical Research Associate (CRA)
•  Senior CRA
•  Clinical Team Leader
• Project Manager
• Senior Project Manager
• Manager Medical & Regulatory
• Manager –Safety / Patents
• Manager Quality Assurance 
• Medical Director
•  Associate Director –Clinical 
• Associate Director –Projects
•  Director –Business Development 
• Director / Head (Clinical Operations)
•  General Manger / CEO / President

Job roles in SMOs [4]

•  Clinical Research Coordinators (CRC) / Study 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 Manager / CEO / President

Job roles in DM [4]

•  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

Courses in Clinical Research

A course in clinical research, followed by a basic graduation or post-graduation in the field of medical science, life science, dental science, pharmacy and pharmacological science, can definitely open up many opportunities to create a career in the industry. A typical course in clinical research includes information about basic pharmacology and pharmacy in clinical research, guidelines and regulations in clinical trials, ethics in clinical research, biostats & clinical trials design, clinical trial documents, clinical trial management, drug safety & pharmacovigilance etc. A specialized course will generate well trained, experienced and resourceful professionals with formal trainings in research methodology, good clinical practice (GCP), regulatory affairs, documentation and conducting impeccable clinical trials.

Turacoz Skill Development Program offers you with a six-month diploma course in Clinical Research and Scientific Writing. The course gives an in-depth knowledge about clinical research and different types of scientific documents including publication and medico-marketing documents.

Learning Objectives:

After taking this course, you should be able to understand the –

• Basics of clinical research, drug discovery and development.
• Protocol, informed consent form, clinical summary report.
• Ethics in clinical research and publications.
• Scientific publications and role of medical writers in scientific publication.
• Lifecycle of a manuscript - Planning, writing, reviews and finalization and submission.
• Importance of conferences and documents involved in conference support – abstract, poster and oral presentation Types of medico-marketing documents and different deliverables.

Have a look at the courses we offer, by clicking here.

Contact Dr Smriti Khatri, Manager of Business Development and Training at Turacoz Healthcare Solutions for any further information or quires.

References:

[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149409/

[2] https://www.fda.gov/patients/drug-development-process/step-3-clinical-research#Clinical_Research_Phase_Studies

[3] https://www.grandviewresearch.com/industry-analysis/india-clinical-trials-market

[4] https://cliniminds.com/presentation/Files/gujarat.pdf

Author: Madhu Kumari

The Benefits of Pursuing Pharmacovigilance Course

India’s pharmaceutical business is growing rate of 12–14% per annum. It is emerging as a major hub and pharmacovigilance is in the spotlight for healthcare industry. Pharmacovigilance (PV) plays an important role by monitoring the adverse effects of medical drugs throughout the drug development process, clinical trial and even when the drug is marketed. Pharmacovigilance is also abridged as PhV and in layman’s terms, it is drug safety. The World Health Organization (WHO) defines “PV as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”. PV involves rigorous monitoring and that might lead to withdrawal of many drugs from market or may prevent their commercialization in market at times.

PV course promotes clinical training and understanding of the risks and benefits of medicines, adverse events reporting, consumers and regulators on use of drugs. It also involves proactive reporting on the quality, safety and efficacy of medicines. The course covers key aspects of career which includes adverse event reporting, report writing, early signal detection, narrative writing, seriousness criteria assessment, risk-benefit management, information on regulatory bodies involved country wise. 

Benefit of Opting Pharmacovigilance as a Career Option:

PV is a well-defined employment option for medical, life science and pharmacy graduates with numerous opportunities. It is due to the pharmacovigilance professionals’, that drugs in the market are safe for consumption and harmful drugs are often withdrawn from the market. Globally, many pharmacovigilance centers are working towards drug safety and are maintaining large databases. which pushes the pharmaceutical companies to outsource their work to countries like China, India etc. for cost effectiveness. This provides an opportunity to get jobs in various pharmaceutical companies and earn attractive package.

Responsibilities of Pharmacovigilance Professionals:

• Serves as the main link between pharmaceutical company and healthcare experts to provide valid information on drug safety
• Ensures that drugs are safe for patients and identifies any new safety information (signal)
• Handles adverse event in safety database
• Flags up early warning signs of adverse effects of drugs

Firms that appoint Pharmacovigilance Professionals:

Pharmacovigilance students can find enormous employment options in the following organizations:

• Contract research organization (CROs)
• Pharmaceutical companies
• Biotechnology firms
• Regulatory authorities and drug safety consultancies
• Regional pharmacovigilance centers and hospitals
• Knowledge process outsourcing (KPOs)

Average Pay-scale in PV:

• Fresher: Rs. 20k-45k
• After 5 years: Rs. 80k-1 lakh
• After 10 years: earn up to Rs. 3 Lakh

Opportunities in Pharmacovigilance

Figure 1: Career Ladder in Pharmacovigilance

PV offers jobs in report processing, in literature search and medical review, aggregate report preparation, screening and reporting, pharmaco-epidemiology, and risk management, labelling etc. 

Courses Offered:

The government is also supporting and emphasizing institutes to train students on PV as they can understand adverse effects of pharmaceuticals and work for human wellbeing. There is huge need for well qualified and trained people who could take PV jobs in drug companies. If a student or professional needs to strengthen his/her resume, there are specialized certificate and diploma courses to grab better opportunities.

Turacoz Skill Development provides up-to-date training to professionals and students who would like to opt for various opportunities in PV. The courses provided by Turacoz are:

Professional diploma in pharmacovigilance

Post graduate diploma in pharmacovigilance & medical writing

Post graduate diploma in scientific writing & clinical research

These courses have been planned by pharma experts from the industry themselves and thus it covers whole pharmacovigilance theoretical and practical knowledge for industry. The primary aim of the Post Graduate Diploma Program in pharmacovigilance is to familiarize the student with the updated theoretical and practical aspects in Pharmacovigilance. Students enrolled in online and offline certificate courses will be given exposure to practical exercises, training in detection of signal, data entry in database. Thus, in these courses students and professional will get maximum exposure to practical skills required in PV planning and execution.

Conclusions: 

PV is a great employment option for pharmacy, medical and life science graduates. A career in PV requires suitable qualification and proper training for processing and analyzing data. The PV course provides adequate knowledge and up-to-date training to students who would like to opt for various career opportunities in PV. The skill development program and training in PV is important and are provided by various institutes in India. The course module covers basic principles of pharmacovigilance, regulatory compliance, quality assurance, safety monitoring and all the key aspects in PV. These courses are designed for the aspiring students to make their career in PV as they get maximum theoretical and practical exposure via course.


Author: 

Aayushi Ambastha

You Can Achieve Your Dream of Becoming a Medical Writer! Read This to Find Out How

Not every medical writer owns a degree in medical science. You must be surprised to know that becoming a medical writer is not that complicated as you think. Many people who own a degree in science cannot be writers. It takes a few extra skills and potential to be one. Your degree cannot define your skills and interest that is required for writing.

Keeping certain factors aside, there is a whole universe waiting for you. This post will tell you how you can enter the world of medical writing and establish yourself as a medical writer.

The common questions related to medical writing for an individual are:

• How do I venture into medical writing?
• Where to knock for opportunities in medical writing?
• How do I select the topic on which I will be writing?

Starters: How to begin with medical writing?

All your questions will be answered by the end of this post, so stay tuned.

For now, we will be kicking off with the basics. Starting with:

What is medical writing, to be precise?

This question opens an authentic can of worms of imperceptible answers.

Before stepping on this stone, let’s understand the concept of medical communications. Medical communication is divided into 3 main categories; medical writing, scientific writing, and health writing.

We will begin with scientific writing first.

Scientific writing:

It comprises of writing academic publications, scientific journalism and other types of technical writing. Its orientation is medical, but it has more to it. It focuses on the basic elements of science, industrial research, social science, etc.

Medical writing might not always look like scientific communication.

Health writing:

It involves writing of articles, educational content and other content which is oriented towards patients and consumers.

Some doctors have been successful bloggers too, writing about health. Blogging is not a cake-walk but you can certainly make big in it if you have the right skills and go on generating a great source of income.

You can also learn the required skills as it is never too hard to learn.

Main course: Medical writing

Finally, we are arriving at it: Medical Writing!

Medical writing is closely in connection with scientific communications and relates to health writing, too. It is more technical in nature and caters usually to B2B (Business to business) requirements.

It includes generation of well-structured scientific documents, inclusive of clinical research documents, writing for healthcare websites/magazines, news and journals.

It is further divided into 3 broad categories, discussed below:

#1 Regulatory Writing:

The writers involved in regulatory writing generally work with biotech organizations, clinical research organizations, pharma companies, and device manufacturers and government agencies.

The documents worked upon are core technical in nature. Regulatory writers communicate essential information to government bureau, regulatory authorities and other reviewers.

Summarizing of complex scientific and statistical information and data for getting reviewed by New Drug Application (NDA), is an example of regulatory writing.

The tasks that regulatory writers perform is crucial for the organizations dealing with the excessively expensive procedure of device and drug recovery, advancement and advertising.

Skills required to be a regulatory writer:

Having a scientific background may not hurt your back, but it is not a hard and fast rule to be from a clinical or scientific backdrop.

There are many courses which help you in learning the basics of regulatory writing. In the era with a strong presence of internet all over, grab a course which would help you in getting started with regulatory writing. Conduct research on various courses available and choose the one that fits your need.

AMWA (American Medical Writing Association) has its own course to offer. You can choose to go with these courses. This job has a high level of financial stakes and complexity, thus, people who prove their worth would be on the sunnier side.

#2 Promotional Medical Writing:

It comprises of educational content writing for a distinguishing product or brand. It is basically content marketing for the healthcare industry. Now marketing here does not mean lying and this part of medical writing holds its certain importance which should not be overlooked.

The purpose of promotional medical writing is not to mislead but promote and inform patients, readers or consumers about a specific brand or product/service. Promotional medical writing comprises of creating sales training materials, advertising copies, product monographs, etc. to drive readers to action..

Skills required for promotional medical writing:

There was a time when unethical people crept into promotional medical writing, but not anymore. Today, promotional medical writing is under great surveillance and is regulated well.

An honest and skilled writer would never go out of fashion, that is for sure and would make it big in this style of writing.

For you to be a good promotional medical writer, having some awesome copywriting skills would help a lot..

#3 Educational Medical writing:

Medical education comprises of the writings that the physicians are acquainted to see. You look for CME (Continuing medical education) organizations, disease monographs, board-review preppers and other opportunities in educational writing.

The motive behind this is to inform and educate readers about a specific product/brand/service, without making any biased conclusions and drawing them towards a specific brand/product/service. It is fact-oriented.

Physicians interested in teaching can write for the companies they prefer/like, be a part of a podcast or even tutor students. One can also play the role of subject matter expert for those who are not a pro in this domain.

The CME industry has opportunities flowing for contributors wanting to pursue careers in this domain. Every sort of communication commences with writers.

Skills required for education medical writing/CME:

You need to be informed about the subject you are going to write. A dynamic style of writing is going to gain you some plus points as the content is required to be informative and engaging at the same time. The focus is to keep your readers ‘awake’.

How to become a medical writer?

Another entry into the most googled ‘How to...’ series.

To be an impressive medical writer, you need to have below mentioned key qualities in you:

• Reading
• Writing

These 2 are essential for becoming a good writer. If you have come down all the way to this section of the post, then you already are a good reader. ‘Writing’ is the part where most of the people struggle. The below mentioned points will help you in easing the troubles with writing part-

• Create a portfolio

Your portfolio reflects your capabilities as a writer. This is very crucial when you’re thinking of becoming a medical writer. Compile your best work and showcase it to the prospective clients to make them believe that you are the best fit for them.

In case if you have not written anything previously, need not worry. The thing to understand is that you need to have something relevant for showing to the clients to make them hire or else they will hesitate in choosing you.

If you have not written/published anything earlier, now is the time. Write articles, posts, blogs or medical education case that will add to your portfolio or will be self-published, without actually being published.

• Make your own website

Let your modus-operandi be your website. It doesn’t matter if you don’t have clients currently. Have your own platform to publish your writings. In the era of internet and social media, it is very important to have your presence on the web, to get noticed by the right people.

Having your own blog and website will not only catch the attention of relevant people/clients but will also add as a source of additional income.

Getting your website might not seem an easy task. You must get a host; domain name and you also need to learn to maintain your website. It surely takes some time to see the results, but it is worth all your patience and wait.

Today, making a website is not that difficult as there are various companies helping you with it. Companies like Bluehost, WordPress, etc. give you the comfort of designing your own website. You invest a small amount and the benefits in comparison to the amount paid are huge.

• Go for guest posting

In case you don’t want to start with your own website, you can go for guest posting. There are extant platforms where you can pitch in as a guest blogger/writer. Find relevant sites for your content and start posting. Medium is also a good platform to start writing your posts. This will help you in getting exposure in terms of writing for the public.

• Don't hesitate in making professional surges

Networking is the best thing you can do to learn, grow and grab an opportunity. Join professional medical writing associations and form connections with your fellow members. Create a professional CV and upload it on the web so that people can have a look at your potential, skills, and qualifications. This will serve as an opportunity provider for you.

• Opt for Medical writing courses

To groom as a medical writer and learn and enhance your skills, go for various medical writing courses. There are various online medical writing courses that are self-paced and help you with what you need. These courses will help you learn better and improve your writing skills.

We, Turacoz Skill Development Program (TSDP), offer six-month diploma course in medical writing, pharmacovigilance and market research for which you can enroll by clicking here.

We make you learn the basics of medical writing and help you learn relevant skills and expertise and make you industry-ready.

Developing skills for medical writing

You need to get your head straight into this field if you want to see yourself earning decent in this profession, a few years down the lane. However, a little preparation prior to getting in this field is not a bad idea. Some people like to go by a game plan and learn the required skills before venturing into anything.

You can be one such individual who is prepared for the new role. Most medical writers are required to meet the passing cognition with AMA style of writing, exceptional writing skills, and detail-orientation. Work on your strengths and develop the core skills for medical writing. For instance, to be able to write well, you need to write more and more. Learning and practicing is the key. You can go for self-paced online courses and our six-month diploma course is available both in online and offline mode, giving you the comfort of learning from anywhere.

Soak up all the information that is available for free on the internet. Follow relevant blogs and websites. Read work published by other authors.

Hope this post helped you with your queries. To know more about us and the courses we offer, write to us at trainings@turacozskilldevelopment.org