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

What Is Scientific Writing and How to Be Proficient in It?

Scientific writing does not limit itself to just writing about science, but, it’s a form of technical writing that scientists practice to communicate their research to other scientists. The aspects of the writing may vary such as the target audience, the purpose or the organization, depending on the specific scientific genre.

Journal articles, research proposals, scientific poster, etc. are some of the scientific writing documents. Scientific writing is based on scientific inquiries and extensive scientific research so the same level of precision is required to be maintained in the writing as that of the research.

The choice of words and clarity should be kept in mind as the person writing is technical but the people to whom it would be exposed might not be as informed as the writer.

Mentioned below are some prominent features of good scientific writing:

• The main audience is the scientist lobby: As stated earlier, scientific writing is used to communicate the research results to other scientists so the language must be professional. It shouldn’t be wordy or too distracted from the main objective.
• It's to-the-point and specific: The main objective of scientific writing is to communicate scientific information clearly and precisely. Making it too loud, wordy or casual fails the purpose.
• It should be organized within the framework of other published work: Dynamism is the key to science. Science keeps updating and reinventing itself, thus, it should be set into the backdrop of the previous related findings and work. This serves as a motivation for the new paper or research being conducted in a specific area.

Golden rules for scientific writing:

• Appeal, inform & influence the reader/audience
• Be clear with your language and stay reader-oriented
• Ward off any deviations
• Do not explain overly & avert overstatement
• Try to avoid futile redundancy
• Avert irrelevant attributes
• Use explicit words
• Be persistent with the usage of tenses
• Don't use too difficult terms and keep it rather simple with solid examples
• Use simple sentences over the complex ones
• An agreement between subject and verb is required
• Use conversions
• Proper citation of sources and findings
• Avoid using ‘this’
• Conduct proper proofreading

Scientific writing involves adherence to strict protocols and technicalities. What can you do if you aim to be a successful scientific writer?

Join Turacoz Skill Development Program (TSDP). TSDP offers ‘Certificate course on scientific writing and conference presentation’.

What will you learn?

Individuals can look forward to learning:

• Fundamentals of scientific publications
• The job of medical writers in the drafting of a scientific publication
• Importance and types of publication documents
• Planning a manuscript
• Ethical considerations in scientific/publication writing
• Selecting the target journal
• Submitting procedure of manuscript, post-submission work and peer-review process follow-up

This 2-month long course offers an in-depth understanding of a different boulevard of publication writing and ethics. The training is imparted by professionals and the course curriculum is designed keeping in consideration the requirements of the individuals and is focused on making them a good scientific/publication writer.

The online mode of classes makes it easy for an individual to access the course from anywhere and the study materials provided are the best. The continuous assessment gives individuals a chance to improve and move ahead with a steady pace of learning.

This course is meant for anyone who is willing to establish his/her career in publication mainstream in the medical domain.

To get more details about this course and to know more about us and the courses we offer, write to us at trainings@turacozskilldevelopment.org

To register for this course, click here.

To People Who Want To Start Pharmacovigilance Writing But Are Afraid To Get Started

Medical writing is a wise career option for all those who have a knack for writing and are into science. The recent years have seen an escalating demand for medical writers and pharmacovigilance is one such segment of it, which is gaining extreme popularity.

Science had developed with a great pace and advancements have been made into the medicine sector. Various new drugs are being developed for the treatment of various diseases. With the rapid inventions of new drugs, the question of the safety and efficiency of the drugs remain persistent. Pharmacovigilance tends to answer this question.

Pharmacovigilance writing:

Pharmacovigilance writing deals with every aspect of drug development. It starts with the clinical trials continuing with submission of essential reports prior to the market authorization of the drug and goes forward till the post marketing of the drug.

Skilled writers, who can put in the efforts and expertise in clinical development and various technical aspects into the various related documents, to make the documents authentic and in accordance with the guidelines.

When going through the clinical development stage, a drug is required to have accurate reports on the safety and efficacy in the trials. The adverse effect of the drugs and the safety levels are measured from the reports from trials.

Benefit-risk regulatory reports are the key document/feature for a pharmacovigilance writer. They write the analysis of the safety and efficacy of the drug with an aim to bridge the gap between healthcare professionals and public in general enabling patients to develop a trust for the drug.

To be precise, pharmacovigilance writers contribute in the clinical drug advancement by giving inputs using their expertise in developing the clinical plan outlines and structuring clinical drug advancement programs for developing the drugs for the use of masses.

Why choose pharmacovigilance writing as a career?

More and more clinical researches are being conducted today. Pharmacovigilance counts for an integral part of clinical researches. Various pharmacovigilance organizations are working on drug safety control. The pharmacovigilance systems are facing a major human resource crisis and there is a lot of demand for the pharmacovigilance writers who can work on various clinical documents focusing on the safety and efficacy of drugs and help in the various documents related to the drug development process.

New drugs take time to reach the market as before they are out for sale in the market for the patients to use, they have to go through strict trials wherein their safety and adverse effects are measured and compared with that of their efficacy and efficiency levels and it is analyzed whether or not the drug is capable of treating the desired ailment and if it is worth taking the risk, I.e. the ratio of risk is to benefits is compared and then further decisions are made. The drugs must go through certain regulatory phases to achieve the ultimate goal of market authorization.

Seeing the current demands for the pharmacovigilance writers considering the significance of pharmacovigilance in the clinical and medical sector, it is a wise option to go for pharmacovigilance writing.

Pharmacovigilance writers can find work at:

• Pharma companies
• Contract research organizations
• Regulatory organizations
• Government regulatory agencies
• BPOs & KPOs
• Site management firms
• Regulatory consultants

How to ensure a successful career in pharmacovigilance?

If you are among those people who want to establish themselves into the field of medical writing but are concerned about how to start, this post helps you resolve your concern. Turacoz Skill Development Program offers 6-month diploma course in pharmacovigilance medical writing, where the individuals are made to understand everything about this sector, starting from the basics to the advance course.

This diploma course is targeted towards providing industry’s practical perspective in clinical research, drug advancement, documentation during drug development procedure, drug safety and various pharmacovigilance skills required in the industry. The motive behind this course is to make a successful pharmacovigilance professional.

The scope of this course is not just restricted to domain-specific training, but also involves personality development. Turacoz Skill Development Program offers various other courses such as regulatory writing course, freelance medical writing course, scientific writing, etc.

To know more about the courses, you can write us at trainings@turacozskilldevelopment.org

To register for the courses, click here.

What makes a good scientific writing and how can you be a good scientific writer?

A lot of data is available on the web about what is scientific writing and even what it is not. However, many people who aspire to be a scientific writer, still could not find a clear guidance on how to begin with it. This is mainly because most of the available articles are either difficult to understand or never really help you.

Here in this post, understanding of scientific writing and its nitty-gritty is made easier for you. Let’s begin with understanding what is scientific writing.

Scientific writing is a specialized type of writing that is intended to impart logical data to different researchers. Contingent upon a particular scientific genre—a journal article, a scientific publication, or a research proposal, for instance—a few parts of the writing may change, for example, its motive, audience, or association.

What makes a good scientific writing?

A good scientific paper has the following characteristics:

• Precise: It doesn’t include irrelevant details and is to the point.
• Clean:  It is in a language which is easy to understand and straightforward.
• No excessive use of technical jargons: They are used only when required. Rest of the document must be easily readable & understandable.
• Unbiased: A good scientific paper avoids any conjectures & any unproven statements. It showcases the source of data and how it was collected and back it up with testimonies.
• Framed reasonably: All the ideas and procedures are penned down in a logical sequence.
• Well-defined: It avoids the use of uncertain and inexplicable language like about, approximately, almost, etc.
• Unprejudiced: Whatever the statement and ideas are there, they are supported by proper testimonies and are further presented with the derived conclusions along with considering the works of others.

Career as a scientific writer is surely a lucrative choice. A scientific writer works on a variety of scientific documents like:

• Original research articles
• Quality Check
• Review articles
• Meta-analysis
• Systematic review
• Case reports & series
• Posters & oral presentations
• Book chapters
• Editorials

Working on so many kinds of documents brings in a lot of learning for a scientific writer but also demands a lot of responsibilities on the writer’s part.

The role of a scientific writer demands the following:

• Thorough knowledge of science and medical terminologies and technicalities
• Good knowledge of scientific procedures and documents
• Knowledge of any medical field
• Strong literary skills
• Ability to convert complex information into an understandable format

It doesn’t matter if you are a novice or someone experienced, if you have the right skills you can make your career as a scientific writer work out the best for you. You can take up various scientific writing courses as well. 

Turacoz Skill Development Program offers the best and most effective course for the budding and professional scientific writers. The scientific writing course is designed in a way to meet the challenges and requirements of the industry and focuses on building the skills of the aspiring writers and enhancing the skill-set of the professionals.

The candidates are equipped with the basic and professional knowledge and skills. With this scientific writing course, you can always have an edge over the competition and establish yourself well in the field of scientific writing.