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

Pharmacovigilance Writing: The Vogue in the World of Medical Writing

Pharmacovigilance is a crucial element of drug advancement and marketing. Monitoring the safety of patients and identifying the adverse effects of drugs and their potential and benefits is a task which is highly regulated on a global level and is continued throughout a drug’s lifecycle. The consequences and end results of these analyses are presented to health authorities in form of periodic aggregate reports and other pharmacovigilance (PV) documentation like RMPs (Risk Management Plans) are in demand by regulations all over the world.

A pharmacovigilance writer plays a very important role in producing these documents and even managing them. An expert PV writer offers PV expertise, comprehensive knowledge of guidelines, regulations and other requirements, formatting, documents, content specialization, communication & writing and skills related to project management. The presence of these skills makes it certain that the submission of patient safety, information on safety level of drugs, adverse effects of drugs and the analysis of risk by the companies to the regulatory authorities are clear and steady throughout the entire course of PV documents and that these documents are drafted on time and in an effective and efficient fashion.

What is PV writing?

Pharmacovigilance (PV) writing focuses on each aspect of drug development making its way from clinical trials through required report submissions before getting authorization from the market and all the way to the post-marketing state.

Skilled writers are in demand who can apply their functional expertise and knowledge of clinical drug advancement to handle the technical specifications of the documents, so the end document meets all the regulations and guidelines.

During the phase of clinical advancement of any drug, safety and efficacy report of the drug is required in clinical trials. The reports are made up post determining the safety data from a considerable proportion while it is being submitted for the marketing authorization.

PV writers are involved in writing Benefit-Risk regulatory reports, all that while till the product is available. PV writers aim to bridge the gap between medical health experts and the general public through their analysis of drug efficacy and safety and thus help to build trust in patients regarding the usage of drugs.

To sum up, pharmacovigilance writers furnish in clinical drug advancement by offering their scientific competence in formulating the clinical plan blueprint and structure of clinical drug advancement programs so that the drugs can be developed accordingly for human use.

Why Choose a Career in Pharmacovigilance Writing?

Pharmacovigilance is an integral part of clinical research and is growing exponentially. Many PV centers are breaking a sweat to work on drug safety control but the issue that lies down beneath the surface is that pharmacovigilance is facing an extensive shortage of human resources and there is a huge demand for skilled professionals. When it comes to new drugs, one must be extremely careful as they take a long time to reach the market following the entire regulatory course which determines their safety and efficacy level to assure that they can receive a market authorization.

Where can you find a job as a PV writer?

A PV writer is hired by the following organizations:

·         Pharma companies

·         Contract research organizations

·         BPOs/KPOs

·         Regulatory firms

·         Regulatory consultants

·         Site management organizations

·         Government Regulatory Bureaus

How can You Commence Your Career as a PV Writer?

With the six-month diploma course in medical writing, pharmacovigilance and market research, offered by Turacoz Skill Development Program (TSDP), you can rest assured to have a reliable and competent entry into the world of pharmacovigilance writing.

The course offered by TSDP will help you in learning:

·         Fundamentals of clinical research

·         Drug disclosure and advancement

·         Fundamentals of pharmacovigilance

·         Literature search

·         Medical jargons

·         MedDRA, etc.

The course is designed keeping in consideration the industry standards and requirements and is taught through a blended mode. The course focuses on making individuals industry-ready and works beyond technical aspects to even groom them personally and professionally.

TSDP also provides placement and career development support. One can expect to learn all the basics of pharmacovigilance, new trends in PV and develop professionally to start their career as a pharmacovigilance writer.

We bridge the gap between academics and the practical skills required for medical writing.

To register yourself for this course, click here. To know more about TSDP and the courses we offer, write to us at trainings@turacozskilldevelopment.org