- Introduction to Clinical Research
- Terminologies in Clinical Research
- Advantages of CR in India
- Introduction to Clinical Research- Notes
- Introduction to Clinical Research Quiz
Clinical Data Management Courses Details:
Clinical Data Management (CDM) is a crucial component of clinical research, which involves the collection, management, and analysis of clinical trial data. TechnoBridge Systems offers a comprehensive Clinical Data Management course that covers all aspects of CDM. Our course content is designed in order to fulfill the current requirements of the entire clinical research industry. The curriculum includes modules on database design, data entry, validation, cleaning, and reporting. Students also gain knowledge of regulatory guidelines and industry standards for CDM. The course is ideal for B Pharmacy and life science graduates who want to make a career in clinical research.
TechnoBridge Systems is a leading training institute that offers comprehensive Clinical Data Management courses in Pune. Our courses are designed to equip students with the knowledge and skills required to build a successful career in Clinical Data Management. Our courses are designed to meet industry standards and regulatory guidelines, and our experienced faculty members ensure that students receive the best possible training.
Top Clinical Data Management Courses in Pune - By TechnoBridge
| Course Name | Duration | Fees |
|---|---|---|
| Regulatory Affairs Course | 3 Months | 20K/- |
| Clinical Data Management Course and Pharmacovigilance Course | 2 Months | 15K/- |
| PG Diploma in Clinical Research (PGDCR) | 3 Months | 20K/- |
| Clinical Data Management Courses | 1.5 Months | 10K/- |
What is Clinical Data Management Course Eligibility & Duration?
The eligibility criteria for the Clinical Data Management course at TechnoBridge Systems are a degree in B Pharmacy, BSc, MSc, or any life science discipline. The duration of the course is 1.5 months, and it covers all the essential aspects of CDM. The course is designed to provide 100% job-oriented training and placement assistance to all students.
Clinical Data Management Course Key Highlights:
The key highlights of the Clinical Data Management course at TechnoBridge Systems are as follows:
- 100% Placement assistance
- Life Time Access to the Course
- Unlimited Placement Call
- 27+ Years Industry Experts
- Mock Interviews
- Flexible Batch Timings
- Affordable Fees
- Industry-recognized certification
- Detailed Curriculum
Clinical Research Course Content [Updated 2023]
The Clinical Research Course content at Technobridge System is updated regularly to ensure that students receive the most up-to-date knowledge and skills in the field. As of 2023, the course content includes:
- Introduction to Clinical Research: This module covers the basics of Clinical Research, including the history, definition, and types of Clinical Research.
- Clinical Trial Design and Methodology: This module covers the design and methodology of Clinical Trials, including trial phases, study designs, and ethical considerations.
- Good Clinical Practice (GCP) and Regulatory Affairs: This module covers the principles of Good Clinical Practice (GCP) and the regulations and guidelines governing Clinical Research, including International Conference on Harmonisation (ICH) and local regulatory bodies.
- Clinical Data Management: This module covers the process of collecting, verifying, and storing Clinical Trial data, including data entry, data validation, and database management.
- Statistical Analysis in Clinical Research: This module covers the statistical methods used in Clinical Research, including hypothesis testing, sample size determination, and data analysis.
- Monitoring and Auditing in Clinical Research: This module covers the process of monitoring Clinical Trials, including site selection, initiation, monitoring, and close-out visits
- Drug Development Process: This module covers the drug development process, including preclinical trials, IND/CTA submission, and the regulatory approval process.
- Project Management in Clinical Research: This module covers the principles of project management and the skills needed to manage Clinical Trials, including risk management, budgeting, and timelines.
- Career Opportunities in Clinical Research: This module covers the various career paths available in Clinical Research, including positions in clinical operations, data management, monitoring, and regulatory affairs.
This comprehensive clinical research course syllabus provides students with a solid foundation in Clinical Research and prepares them for successful careers in the industry. The course content is delivered through a combination of lectures, case studies, and hands-on projects to provide students with a well-rounded education.
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
Pharmacovigilance
- 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
- CRF_Design_2
- Introduction to CDM
- Data Entry Methods
- Query Management
- Source data validation
- Future of Data Management
Regulatory Affairs
- Application of Permission
- Approval of Clinical Trial
- CDSCO
- Code of Federal Regulation (CFR)
- CT_Rules_2019
- ICMR Guidelines
- Medical Devices
- ICMR Guidelines
- DoH Oct 2013
- Guidelines for Industry
Protocol Designing
- Drafting a study protocol
- Study Design
- Informed Consent
- Design of Trial- Notes
- Protocol Designing- Quiz
Why Choose Clinical Data Management Courses at TechnoBridge?
TechnoBridge Systems is a leading corporate training institute that provides top-quality training in the field of clinical research. The institute offers comprehensive Clinical Data Management courses that provide online live training with the latest tools and technologies used in CDM. The faculty members are highly experienced professionals who have worked in the clinical research industry for many years. TechnoBridge Systems has connections with several top pharmaceutical companies and CROs, providing students with excellent job opportunities.
Salary & Certification for Clinical Data Management Professionals:
Clinical Data Management is a lucrative career option, and professionals in this field can earn a good salary. The salary of Clinical Data Management professionals depends on various factors, such as their qualifications, experience, and job location. According to Payscale, the average salary of a Clinical Data Manager in India is around INR 6 lakhs per annum. Data Management professionals can also get industry-recognized certifications, such as CDISC, GCP, and SAS, which can enhance their career prospects.
What are Future Career Opportunities in Clinical Data Management in India?
There is a high demand for Clinical Data Management professionals in India, and the future career prospects in this field look promising. Data Management professionals can work in various roles, such as Clinical Data Manager, Data Analyst, Database Programmer, and Clinical Research Coordinator. With the increasing demand for CDM services in India, there are excellent job opportunities in pharmaceutical companies, CROs, and other healthcare organizations.
The high demand of CDM is expected to continue in the coming years, with an increasing number of clinical trials being conducted in India. As a result, the career opportunities for CDM professionals are abundant, and the prospects for growth and advancement are promising. Some of the future career opportunities in Clinical Data Management in India include:
- Clinical Data Manager
- Clinical Data Analyst
- Clinical Research Coordinator
- Database Programmer
- Clinical Data Scientist
- Clinical Data Quality Manager
- Regulatory Affairs Manager
- Medical Writer
- Clinical Data Coordinator
What is the Scope of Clinical Data Management in India?
The scope of Clinical Data Management in India is vast, and it is a growing industry. With the increasing number of clinical trials being conducted in India, there is a high demand for skilled professionals in the field of CDM. The industry offers several career options for professionals with expertise in Data Management, including Clinical Data Manager, Clinical Data Analyst, Database Programmer, and Clinical Research Coordinator. The scope of Clinical Data Management in India is expected to increase in the coming years, with the rise in demand for CDM services in the healthcare industry. Professionals with certification in Clinical Data Management can expect to have better job prospects and higher salaries.
Our Placement Process
Eligibility Criteria
Placement Training
Interview Q & A
Resume Preparation
Aptitude Test
Mock Interviews
Scheduling Interviews
Job Placements
Sectors Where Candidates can find opportunities:
Clinical Data Management professionals can find job opportunities in various sectors, including pharmaceutical companies, CROs, hospitals, and research institutions. The healthcare industry is the primary employer of Clinical Data Management professionals, and the demand for skilled professionals in this field is increasing with the growth of the industry. Candidates with expertise in Clinical Data Management can also explore job opportunities in the IT sector, as several IT companies provide CDM services to the healthcare industry.
What are the Companies and Clients for Clinical Data Management?
Several top pharmaceutical companies and CROs in India provide Data Management services to the healthcare industry. Some of the leading companies that offer CDM services include QuintilesIMS, Parexel, Cognizant, and Wipro. These companies offer excellent job opportunities for Clinical Data Management professionals, and many of them have tie-ups with TechnoBridge Systems for training and recruitment. Candidates can also explore job opportunities with research institutions, hospitals, and other healthcare organizations that conduct clinical trials.
Course Review
Frequently Asked questions
What is Clinical Research?
Clinical Research is a branch of healthcare that deals with the trials of new drug. This research includes trials on healthy human beings and the patients at initial stage. It’s done to decide a line of treatment for deadly diseases. Clinical research is conducted at various research and medical centers. With the help of new drugs professionals can improve the health of a patient.
What is the Scope of Clinical Research
India is the global hub of clinical trials. So, Many MNC’s are setting up research centers in India. This is because clinical trials and studies are an integral part of clinical research. Clinical research determines the safety and effectiveness of medicines, devices, and treatment. The safety and effectiveness of medicines and treatments are carried out before their availability in the market. Thus, there is a huge demand for trained clinical research professionals. The demand for professionals is not only in India but worldwide too. For example, Clinical Research provides excellent job opportunities in USA, Europe, Singapore and India. There are more than 2.5 Lakh opportunities worldwide in clinical research. Furthermore, the global clinical trials market size is expected to reach USD 68.9 billion by 2026. It is projected to expand at a CAGR of 5.7% during the forecast period. Therefore, there is a huge scope for clinical research in the coming years.
What are the Career Opportunities in Clinical Research
• Clinical Research Associate(CRA) • Clinical Research Coordinator(CRC) • Clinical Research Investigator(CRI) • Business Development Manager • Clinical Research Manager • Medical Writer • Data Manager • Clinical Trial Auditor • Project Manager • Clinical Trial Writer
What is Clinical Research Courses Eligibility
Candidates should have a minimum of 55% in his graduation. Candidates holding any life science bachelor degree to apply for this course.