Post Graduate Diploma in Clinical Trial Management

Postgraduate Diploma by ACRI (Avigna Clinical Research Institute) Bangalore View Contact

Starting from: INR 50,000 Per Course (Taxes As Applicable) Request Info

At the conclusion of this training program participants should be able to

• Learn the process for managing biomedical product development for FDA approval

• Gain an in-depth understanding of the clinical trials process through a modular, operations-focus approach

• Acquire project management skills needed to successfully manage human clinical trials

• Gain a global perspective on clinical trials management to better respond to the growing industry across the globe

• Learn how to respond to ethical issues inherent in clinical trials

• Discover how to use statistical methods to monitor clinical trial outcomes and make decisions

• Gain practical knowledge through real-world case studies and team projects in product development

• Learn from instructors with industry expertise in clinical trials management

It is an online post graduate Diploma course. It includes 3 months online sessions

Syllabus:

Course Curriculum includes:

Introduction to Food and Drug Law

• Regulatory requirements in the U.S. for drugs, biologics, in vitro diagnostics, devices, combination products, dietary supplements and cosmetic products

• Regulations in other countries

• Food and Drug Administration’s (FDA) organization, structure and history

• Medical product development process

• Good Clinical Practices (GCP) – standards and regulations, pre-market and post-market

• Requirements and best practices for post market clinical trials

• Ethical concerns and examination of the role of statistics in clinical studies

Setting Up Clinical Trials

A comprehensive overview of

• Types and phases of clinical trials
• Implementation of Good Clinical Practices (GCP)
• Development of clinical study documents
• Interactions with Institutional Review Board (IRB)
• Identification and qualification of study sites
• Insurance requirements and needs
• Statistical considerations in study design
• Ethical issues
• Setting up clinical trials globally
• Investigator and subject matter recruitment issues
• Inclusion and exclusion criteria
• Project management skills and best practices

Managing Clinical Trials

A comprehensive overview of project management issues such as

• Successful management, monitoring and closure of human clinical trials

• Preparing for and managing regulatory agency audits

• Balancing business goals with ethical issues

• Managing regulatory and statistical issues related to data management

• Monitoring best practices, from a global perspective

• Maintaining a budget and schedule to meet business goals

• Crisis management and conflict resolution

Pre-Market Submission Process

A comprehensive overview of the report process for pre-market submission to the FDA, such as

• Development of timelines for submissions

• Project management principles followed by Regulatory Affairs professionals employed in the biomedical industry

• Incorporation of clinical data into product labeling

• Best practices for negotiating with regulatory agencies

• Ethical considerations

• Statistical issues in submissions

• Post-market clinical study scenarios

• Global perspective on the premarket submissions process

• Trial design

• Interim Analysis

• NDA

Teaching Mode

• Electronic copies will be shared to students

• Lecture slides in PowerPoint format, as used for on-campus classes, made available for Online sessions

• Additional notes arising from on-campus lectures and tutorials will be shared via mail

Weekly and Monthly Evaluation

• Test paper will be shared with the candidates on weekly basis and Monthly basis

• A feedback barometer, through which students are enabled to provide anonymous feedback as to how the subject is progressing on a weekly basis

Additional Features of the course

• E books and SOP’S will be shared via mail to the candidates

• Recent updates of clinical research will be provided to the students via mail

• A feedback barometer, through which students are enabled to provide anonymous feedback as to how the subject is progressing on a weekly basis

System Requirement for Students

• The broad band connection (512kbps and above)

• Head Set

• Link will be sent to the students email id, they have to click on the link and get connected

ACRI (Avigna Clinical Research Institute)

Avigna Clinical Research Institute is modeled on the lines of some of the premier Clinical Research Institutes of India. We are dedicated and committed to provide excellent Clinical Research Professionals to the Clinical Research Industries.
Students and Professionals from the Health Science/Allied Health Science/Life Science can look forward to a robust curriculum and training in the area of Clinical Research coupled with additional training in soft skills and internships in leading Clinical Research Organizations.