Clinical research is a study conducted to understand health and diseases in the particular human body. It is branch of healthcare that governs the safety and effectiveness of medications, diagnostic products, devices, and treatment procedures proposed for human use. Further, can be used for treatment, prevention, diagnosis or for relieving symptoms of a disease.
Who Should Join Clinical Research Training Programs :
Individuals who are interested and fascinated in the process of conducting, designing and execution of any clinical trial that involves in converting the biomedical findings into clinical practice and improves the delivery of high quality healthcare products. Moreover, these conducted programs are been developed to bring various professions together to address the increasing gap in between the pre-clinical trials to clinical trials and to deliver high quality healthcare products. Every individual willing to take the clinical research course need the training in research methodology coupled bio-statistics in order to enhance their skills on top of their core clinical understanding. Additionally, need-based training will upkeep the role integration of researchers and care providers. Various programs are been designed in order to offer them with research understanding and skills that would benefit them to efficiently build their career in clinical research.
Advantages of Clinical Research Programs to the candidates:
- Enhance the proficiency in study-design and demonstrating the difficulty and depth of clinical and translational science applications.
- Attain the all significant skills and techniques to be accomplished to cooperate efficiently with co-workers in basic sciences. In addition to this, other disciplines should be in the successful conduct of high value in clinical trials.
- Recognize and understand how to perform and control the clinical research.
- Engage in various activities that helps in building the abilities necessary to lead multi-disciplinary research teams.
- Improvement in the knowledge about different regulatory authorities and their specification to accept the marketing of healthcare products.
- Gain the information on the use of medical data, use of data databases, and the data evaluation
- Build knowledge in the communication, educational approaches, problem-solving, research & management, related to a clinical research.
Syllabus of the Clinical Research Course:
Following is the summary of the syllabus of Fusion Technology Solutions Clinical Research Course:
- Introduction to Clinical Research:
- Clinical Trial Terminologies
- History of Clinical research
- CPCSEA Guideline & Pre-clinical Trials
- Drug Discovery & Development
- Introduction to Toxicity Studies
- Definition of clinical trial
- Different Phases of clinical research
- Subtypes of Phase 1,2,3, and 4
- E –clinical trial
- Bioavailability & Bioequivalence Studies [BA/BE]
- Drug Regulations & Ethics in Clinical Research:
- Background of ethics
- Declaration of Helsinki
- Belmont Report
- Informed consent Process
- Nuremberg code
- History of Indian regulations
- Schedule – Y- Appendices
- ICMR (Indian Council of Medical Research ) Guidelines
- Indian GCP (Good Clinical Practice)
- ICH GCP (International Conference on Harmonisation)
- Drugs & magic remedies Act 1954
- Drug prices control order
- CTRI-Clinical trial registry of India
- Regulations for AYUSH
- An Introduction to Clinical Data Management
- Data Management Standards
- Set Up
- CDMS (Clinical Data Management System) & CTMS (Clinical Trial Management System)
- Medical coding / Writing
- Close Out
- Assignments and other Activities
- Clinical Trial Documentation, Audits and Inspections.
- Clinical trial documents
- Definition & responsibility of Principal Investigator
- Audit & inspections
- Different types of trial design
- Role of Clinical Research Organization, Site Management and Monitoring in Clinical Research
- Objectives of a Clinical Research Organization
- The Definition & responsibilities and duties of Principal Investigator
- Role of a Clinical Research Organization
- Role of personnel in a clinical trial
Considering the syllabus of the clinical research course at Fusion Technology Solutions, given below is the eligibility course of clinical research course so that candidates can find out if they fulfill the eligibility criteria.
Eligibility of the Clinical Research Course:
The timeframe of clinical research courses at Fusion Technology Solutions is 3 months. Candidates willing to register in the Clinical Research Course must fulfill the eligibility criteria given below:
- The candidate should
be a graduate or post-graduate in:
- Life Science or Biosciences,
- Pharmacy and Pharmaceutical Sciences
- Nursing or Allied Health
Career Prospects after Clinical Research
- Clinical Trial Associate
- Clinical Research Associate (CRA)
- Clinical Research Investigator
- Clinical Trial Auditor
- Clinical Trial Writer
- Medical Writer
Gradually, as one gains experience in the industry, some of the job profiles that one would find in the clinical research industry:
- Data Manager
- Project Manager
- Business development Manager
- Clinical Research Manager
- Manager –Safety / Patents
- Data Analyst Pharmacovigilance
The Candidates are having many choices in Pharmaceutical industry after successful completion of our Clinical Research Training Courses. The trials are conducted over wide range of industries hence CR candidates are having options to enter into following sectors.
- Pharmaceutical Companies
- Biotechnology Companies
- Clinical CRO (Contract Pharmaceutical Companies)
- Pharmacovigilance Centers
- Clinical Data Management Companies
- IT companies in healthcare
- Data management CROs
- Packaging , Labeling and Contract Manufacturers
- Central Laboratories
Salary Package of a Clinical Research Professional:
The package of the candidate after completion of the clinical research course would completely depend on the job profile in the healthcare individual. It may be in the range of 2.5L to the 4.5 annually.