The Clinical Trial Management (CTM) program is an in-depth, highly selective course designed for students with a background in biological sciences, IT, biostatistics, or commerce. The program equips students with essential skills in managing the entire clinical trial process, from study start-up to close-out. Students will learn how to design and manage clinical trials in line with regulatory requirements and ethical standards, focusing on the development of new drugs and treatments.
This course includes comprehensive hands-on training in Oracle Clinical, SAS, and clinical trial management systems (CTMS). Students will gain expertise in key areas such as protocol development, site selection, monitoring, data management, risk-based monitoring, and quality assurance. The program also covers specialized topics like medical decision-making, grant proposal writing for NIH funding, ethics in clinical trials, and the regulatory process for medical devices.
Key courses such as Study Start-Up, Study Conduct, and Study Close-Out ensure that students are prepared to handle all stages of a clinical trial. Additionally, specialized modules like Risk-Based Monitoring, Clinical Data Management & Oracle Clinical, and Medical Device Compliance provide students with advanced knowledge in emerging trends and industry standards.
Course Duration
40-50 Hours
Next Enrollment
March 2025
Mode of Study
Hybrid Learning
Certification
Globally Accredited Certification
Program Highlights
- Comprehensive Training – The program covers every stage of clinical trial management, including study start-up, conduct, close-out, and regulatory compliance.
- Hands-on Experience – Students gain real-time, practical exposure to Oracle Clinical, SAS, EDC, and other industry-standard systems.
- Advanced Risk-Based Monitoring – Learn to apply risk-based monitoring principles in line with FDA and EMA guidance, focusing on efficiency, cost-effectiveness, and compliance.
- Ethics and Regulatory Compliance – Understand the role of ethics and safety in clinical trials, including HIPAA regulations, IRB processes, and the importance of GCP guidelines.
- Medical Device & Biostatistics Knowledge – Specialize in regulatory compliance for medical devices and gain proficiency in biostatistics for clinical trials, including hypothesis testing and statistical analysis.
- Project Management & Writing Skills – Develop project management skills, including budgeting, timeline management, and strategic planning, as well as skills in medical and regulatory writing..
Learning Outcomes
- Manage the Full Clinical Trial Process: From planning and initiation (Study Start-Up) to conducting and monitoring (Study Conduct), through to data analysis and regulatory submission (Study Close-Out).
- Master Clinical Data Management: Gain proficiency in using Oracle Clinical and SAS for data collection, analysis, and integration across clinical trials.
- Implement Risk-Based Monitoring: Apply the risk-based monitoring approach to ensure compliance, cost-efficiency, and targeted monitoring, following FDA, EMA, and ICH E6 R2 guidance.
- Ensure Ethical & Safety Compliance: Understand and apply ethics principles and regulatory requirements for safety, including the roles of IRBs, GCP, and FDA regulations.
- Develop Clinical Trial Documents: Prepare essential documents such as protocols, informed consent forms, and grant proposals, adhering to regulatory requirements like IND/NDA submissions and CTD.
- Analyze and Apply Biostatistics: Conduct advanced statistical analyses, including hypothesis testing, safety evaluations, and subgroup analysis using SAS for clinical trials.
- Understand Medical Device Compliance: Gain specialized knowledge in the regulatory processes for medical device approval and post-market surveillance.
- Write & Manage Clinical Research Projects: Develop project management skills, including budgeting, quality assurance, and timeline management, and gain experience in writing research proposals and scientific papers
Why Choose Yes M Pharma?
Placement Assistance
Strong network of recruiters from the healthcare, pharmaceutical, and biotechnology industries and offer placement assistance to student
Industry Expert Trainers
Equip yourself with skills and knowledge under the mentorship of experienced faculties with over 17 years of experience in the field of healthcare research and training.
Internship Opportunities
Gain hands-on experience in safety reporting tools like Oracle Argus, systematic literature review, meta-analysis, and biostatistical analysis.
A Student’s Journey
Equip yourself with the skills and knowledge required to succeed in the healthcare, pharma, or healthcare-IT industry. Enhance your communication, personality, and technical expertise through hands-on training and real-world case studies.
Earn credentials through online or in-person programs that validate your expertise in the healthcare-IT and pharma sector. Our courses are designed to enhance your professional qualifications and provide industry-recognized certification.
Gain access to volunteer, internship, and placement opportunities in top healthcare settings like hospitals, CROs, and pharma companies. Apply real-world applications of your knowledge and kickstart your career with the right industry connections.
Receive continuous career guidance, resume-building assistance, and networking opportunities with industry professionals. Stay updated with the latest trends in healthcare, IT, and pharma to advance and grow in your career beyond placement.
Career Opportunities
Drug Safety Pharmacovigilance Career Opportunities
Clinical Research Associate (CRA)Career Opportunities
Drug Safety Pharmacovigilance Career Opportunities
Got Questions?
We Have Answers!
Explore our FAQs to find quick solutions and helpful insights.
It covers study design, protocol development, site selection, data management, regulatory compliance, and project management.
This program is ideal for life sciences graduates, medical professionals, biostatisticians, and IT professionals interested in clinical research.
Yes, you will gain hands-on experience with Oracle Clinical, SAS, and CTMS platforms.
You can work as a Clinical Research Associate, Clinical Data Manager, or Regulatory Affairs Specialist.
Yes, it includes USFDA, EMA, ICH-GCP, and Indian regulatory guidelines.
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