ICH-GCP (International Council for Harmonisation – Good Clinical Practice)

Training Highlights:

• Core principles of GCP and ethical research conduct.
• Roles and responsibilities of investigators, sponsors, site and monitors.
• Compliance with regulatory requirements and documentation standards.
• Case studies and practical scenarios for real-world application.

Research Methodology

Training Highlights:

• Fundamentals of clinical research design and study protocols, Informed Consent Form.
• Techniques for literature review and hypothesis formulation.
• Data collection methods, Case Record Form designing and brief statistics.

NDCT (New Drugs and Clinical Trials Rules, 2019)

Training Highlights:

• Overview of NDCT regulations (13 chapters and 107 rules) and their implications.
• Key processes in new drug approval and clinical trial conduct.
• Updates on regulatory compliance and submission requirements.
• Insights into ethical and safety considerations.

ICMR (Indian Council of Medical Research)

Training Highlights:

• Ethical principles for biomedical research on human participants.
• Best practices for Investigator-Initiated research covering medical management & compensation aspects.
• Responsibilities of Head of Institute, Investigators, Ethics Committee.
• International collaborative/multi-centre research.

DNB Thesis Training

Training Highlights:

• Step-by-step guidance for writing and presenting DNB thesis (based on NBE guidelines).
• Research methodology and statistical analysis techniques.
• Common pitfalls and how to avoid them.
• Important points to remember for study execution.

Ethics Committee Members Training

Training Highlights:

• Roles and responsibilities of EC members based on committee’s accreditation.
• Conducting ethical review processes for clinical trials/Investigator-Initiated/academic studies.
• Communication with DHR/DCGI w.r.t SAE causality, medical management and compensation.
• Ensuring patient safety and rights in research.
• Addressing challenges in decision-making and conflict resolution.

Manuscript Writing

We provide tailored training sessions to enhance your manuscript writing skills, designed for researchers, clinicians, and students in the field of science and clinical research. Whether you’re preparing research articles, review papers, or case reports, our expert-led programs ensure you gain the expertise needed for impactful publications.

Training Highlights:

• Structuring research manuscripts (Title, Abstract, Introduction, Methods, Results, Discussion).
• Writing compelling research objectives and conclusions.
• Tips for selecting the right journal and adhering to submission guidelines.
• Understanding plagiarism, referencing, and citation management.
• Effective use of tables, figures, and supplementary data.