- Introduction to Clinical Research
- Terminologies in Clinical Research
- Advantages of CR in India
- Introduction to Clinical Research- Notes
- Introduction to Clinical Research Quiz
Clinical Research Courses | Study in Clinical Research
Clinical research courses can introduce life science bachelors to evergreen and booming clinical research industry. It has been a defining decade for clinical research. India is globally hub as many multinational companies setting up their industries related to clinical research. According to various market research reports the clinical research industry might grow up to 8.5-9 percent from 2019-2021 and then may pick up faster 2022-2026 to around 12 percent. Now these are the golden days for the clinical research industry.
What is Clinical Research?
Clinical research is a branch of healthcare sciences in which research is conducted to understand health and diseases in human beings. In addition to this, it also finds better ways of detecting, preventing, diagnosing, and treating illnesses. Along with that, clinical research defines numerous elements of scientific investigation. To put it simply, it comprises of human participants and helps convert basic research conducted in laboratories into novel treatments and data which can be used to benefit patients. Besides clinical trials, research in epidemiology, physiology and pathophysiology, health services, education, outcomes, and mental health all come under the umbrella of clinical research.
Future Scope of Clinical Research
Clinical research tests whether particular treatments are safe and how they work when given to patients. It opens doors to advancing prevention, treatments, and cures for diseases and disability, clinical trial volunteer participants are essential to this progress.
It also plays a vital role in the development of products to combat diseases, treat chronic and degenerative diseases, and improve the people around the world. The large volume of new drug therapies and devices health under development has dramatically increased the number of drug therapies and devices under development and has increased the number of clinical trials required to evaluate them.
Clinical Research checks the safety of specific treatments and the way they work when given to patients. Clinical trial volunteers play an important role in clinical trials as they help clinical researchers in finding new treatments for diseases and disability. It also aims to develop medicines to prevent illnesses and treat prolonged and deteriorating diseases. As a result, there would be an improvement in the health of patients worldwide. Furthermore, there are new experimental drugs and treatments which have been developed by pharmaceutical companies. Therefore, clinical research professionals conduct several clinical trials to assess these medicines, devices, and therapies. To become the professional of this industry, enroll in Top Clinical Research Courses now.
Clinical Research Courses Syllabus
Introduction to Clinical Research
Good Clinical Practice (GCP)-ICH E6
- History Development of International Regulations in Clinical Research
- Good Clinical Practices
- Ethics committee
- Investigator Responsibilities
- Sponsor Responsibilities
- Protocol and Investigator Brochure
- Essential Documents
- Adverse Event Reporting
- Recording of Event
- Medical Management of Adverse Events
- Handling Death
- Unblinding of Drug
- Clinical Safety and Pharmacovigilance
- E2A- Clinical Safety and Data Management
- Media 436
- Naranjo Assessment
- Order and Formulate to Determine the Quantum
Monitoring of Trials
- Audits and Inspections
- Flow of Events
- Investigational Drug Management
- Routine Monitoring Visits
- Site Visit Flow
Drug Development Process
- Overview of Drug Development
- Clinical trial phases
- BA/BE Studies
- Drug Development Notes
- Drug Development Quiz
Clinical Data Management
- CFR Part 11
- Introduction to CDM
- Data Entry Methods
- Query Management
- Source data validation
- Future of Data Management
- Application of Permission
- Approval of Clinical Trial
- Code of Federal Regulation (CFR)
- ICMR Guidelines
- Medical Devices
- ICMR Guidelines
- DoH Oct 2013
- Guidelines for Industry
- Drafting a study protocol
- Study Design
- Informed Consent
- Design of Trial- Notes
- Protocol Designing- Quiz
After looking at the syllabus of the clinical research course at TechnoBridge Systems, given below is the eligibility course of TechnoBridge System’s Clinical research course so that students can find out if they fulfill the eligibility criteria.
Eligibility for Clinical Research Courses
The duration of clinical research courses at TechnoBridge is 3 months. Students wishing to enroll in the Clinical Research Course should fulfill the eligibility criteria given below:
- The student should possess a minimum of 55% in his or her graduation from a recognized college or university.
- In addition to this, students must hold either a degree in - Life Science or Bio-sciences, Medicine, Pharmacy and Pharmaceutical Sciences, Nursing or Allied Health
Clinical Research Course By TechnoBridge: Why Choose Us?
TechnoBridge’s clinical Research courses have been designed on the lines of the current requirements of the clinical research industry. Considering the fact that the clinical research industry has been growing at a rapid rate, TechnoBridge equips the student with the appropriate skill set in order to be well prepared for corporate life and be able to flourish in the clinical research industry.
Since the ultimate aim of TechnoBridge is to create well trained and competent clinical research experts in the industry; here are some unique features of our Clinical Research Courses which distinguishes us from other clinical research training institutes in Pune:
Clinical Research Courses For Life Science & Pharma Graduates
Our Clinical Research Training Program has been designed in a way that our trainees get certain advantages to transform themselves into trained clinical research professionals. Given below are the advantages:
To conclude, the clinical research industry is one of the promising sectors in the Indian economy. Student needs to enroll for clinical research courses and undergoes training from recognized experts as well as a renowned clinical research training institute to become industry and corporate ready. TechnoBridge assures prospective students that they will not only be well prepared to face challenging situations, but also will climb the ladder of excellence, growth, and recognition in their professional life.
Career Prospects after Clinical Research Course
There are three sectors in the clinical industry sector namely Clinical Research, Clinical Data Management, and Pharmacovigilance. Given below are few job profiles that one will begin within the clinical research industry after clinical research courses:
Clinical Trial Associate
A clinical trial associate is a key team member of several clinical trials conducted by the industry. The professional’s role is of great significance because he or she executes clinical trials right from the start to the conclusion. In addition to this, this professional also is responsible for going through important study documents.
A clinical research associate needs to hold a bachelor’s degree in Lifesciences, pharmacy, or biosciences. In addition to that, one also needs to have the following skills. They are:
- Excellent verbal and written communication skills
- The ability to solve problems
- Organizational skills
- Knowledge of MS Office
- An eye for detail
- The capability to multitask and survive in a fast-paced environment.
The average salary of a Clinical Trial Associate is INR 30,669 per month.
Clinical Research Associate (CRA)
The role of a clinical research associate is vital as they are the bridge between clinical trial sites and the organization which sponsors that trial. They supervise the trial from start to finish. Furthermore, they ensure the trial is conducted smoothly by the team. In addition to that, they make sure data is gathered accurately and effectively.Prerequisites
A clinical research associate must have a bachelor’s degree in nursing, pharmacy or life sciences. Furthermore, they need to have good communication and interpersonal skills. In addition to this, they must be detail-oriented and have good organizational skills. In order to succeed in their profession, they also need to have extensive knowledge of Good Clinical Practice (GCP).
- Clinical Research Coordinator
- Senior CRA
- Clinical trial writer
- Manager –Safety / Patents
- Data Analyst Pharmacovigilance
- Regulatory Affairs Executive
- Clinical trial auditor
- Project manager
- Medical Coding/ Medical writer / Medical & Regulatory officer
Students also need to know about various sectors in the clinical research industry. Given below are the sectors which you would get job opportunities after the completion of a clinical research course:
- Clinical CRO (Contract Pharmaceutical Companies
- Biotechnology Company
- Clinical Data Management Companies
- Pharmacovigilance Centers
- IT Companies in Healthcare
- Medical & Regulatory officer
- Research Organization
- Data Management CROs
- Packaging, Labeling and Contract Manufacturers
The salary package of a clinical research associate is INR 4,00,203 per year.
Medical Writers create varied scientific documents such as regulatory and research-related documents, disease or drug-related educational and promotional literature, content for healthcare websites, health magazines, and news articles. The role of a medical writer is of great importance as they write in language that is understandable to the target audience. The target audiences of medical writers are patients, the general public, physicians, or regulators.
There are some prerequisites required to be a medical writer. These professionals need to understand medical concepts and terminology well. In addition to that, they need to have knowledge of guidelines, structure, and contents of specific documents. Most importantly, they need to have excellent writing skills. They also need to be familiar with researching medical literature, understanding, and presenting research data. Additionally, they need to understand editing and publishing requirements.
After completion of Clinical Research Courses, there is a huge demand for medical writing in the pharmaceutical and healthcare market. They can work independently or full-time in these sectors. Furthermore, life science graduates can make a successful career in medical writing.
The average salary for a medical writer in India is INR 20,683 per month.
Top 10 Companies
TechnoBridge’s students would get job opportunities in the following companies after their clinical research courses.
- 3 Gen Consultancy
- Access Healthcare
- Emcure Pharmaceuticals