Clinical Research

The Clinical Research course at Landmark Research offers a thorough grounding in the essentials of clinical research, covering study design, methodology, ethical considerations, and regulatory requirements.

Participants will gain insights into the various phases of clinical trials, understand the critical aspects of data collection and analysis, and learn the roles and responsibilities of clinical research professionals.

This course is designed to equip learners with the necessary skills to effectively manage and conduct clinical trials, adhering to Good Clinical Practice (GCP) and other regulatory guidelines.

Fundamental Of Clinical Project Management

Key aspects of project management include foundational principles, lifecycles, and methodologies. Focus areas encompass integration, scope, time, cost, communications, stakeholder management, team dynamics, quality, risk, procurement, change management, decision-making, legal/ethical considerations, and project closure and analysis.

Medical Device Investigator Initiated Study

Investigator Initiated Studies (IIS) are valuable assets in medical research. Unlike conventional clinical trials, IIS are often conducted at research hospitals and universities. They fill gaps where clinical trials leave unanswered questions. Conducting an IIS is complex due to factors like limited industry support. In summary, IIS involve cross-functional collaboration, strategic impact assessment, and real-life experiences

Clinical Research Coordinator Certification Program

The module covers the role of a Clinical Research Coordinator (CRC), including their responsibilities, challenges, and opportunities. It provides an overview of clinical development, regulatory history, and guidelines such as ICH-GCP and Indian GCP. Additionally, it details study preparation, documentation management, stakeholder collaboration, study closure, safety management, inspection readiness, and adapting to changes in the clinical research landscape.

Good Clinical Practice and Regulatory Updates

This course provides a comprehensive overview of Good Clinical Practice (GCP) and the regulatory landscape surrounding clinical trials. It covers the historical development of ethical guidelines, ethical issues in clinical trials, the functioning and responsibilities of Ethics Committees, new drug and clinical trial regulations, and the intricacies of compensation in clinical research.

Clinical Research Monitoring and Good Clinical Practice Certification

This course provides a detailed exploration of Good Clinical Practice (GCP) obligations for sponsors and monitors, ethical considerations, and regulatory document management. It covers the development and principles of GCP, informed consent, institutional review boards, and new HIPAA regulations. Additionally, it addresses investigator recruitment, site selection, protocol procedures, monitoring types, and essential site initiation activities, including remote monitoring and compliance with regulatory requirements.

Integrated Clinical Trials and Safety Reporting:

This course offers comprehensive training on clinical trials in medical devices, decentralized clinical trials, patient narrative authoring, ethics committee training for safety reporting, and serious adverse event reporting via the SUGAM portal. It covers regulatory requirements, project management, and automation in patient narratives, ensuring thorough understanding and compliance in clinical research practices.

In-Depth Clinical Trial Design and Drug Development

This course provides a comprehensive understanding of clinical research and trial management, covering fundamental principles, stages of drug development, and key regulatory frameworks. Participants will gain insights into ethical guidelines, essential trial documents, and recent regulatory updates, preparing them for effective and compliant clinical trial conduct.

Advanced Clinical Research Auditing and Risk Management

This course provides an in-depth exploration of auditing principles, quality systems, and risk management in clinical research. It covers essential guidelines, regulatory compliance, and best practices to ensure integrity and quality in clinical investigations.