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CLINICAL TRAILS MANAGEMENT
Global Institute of Health Science is a pioneer in health science education especially in distance & online education. Global Institute of Health Science is an ISO 21001:2018 Certified health science Institute & globally acclaimed, also certified with copyright approval from IPR Government of INDIA. GIHS have international certification from UASL UK for Quality Control Management System.
WHY CHOOSE US
Clinical Trials Management a branch of medical science and research that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use.
These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical Trials is different than clinical practice.
In clinical practice, one used established treatments while in clinical trials evidence is collected to establish a treatment.
This GIHS Clinical Trials Management Program designed to provide total overview and skill globally in the field of Clinical Trials.
It would help professionals to upgrade & develop their knowledge about ICH GCP Guidelines, regulatory issues and other major aspects of clinical research & trial management
It can be able applicable to critically appraise the medical scientific literature, including the methodology of published and proposed investigations
SYLLABUS
Clinical Trails Management
Introduction of clinical research
Indian Regulation (domestic regulation)
Key Stakeholders in Clinical Research
Clinical Trial Design and Project Managements
Principles of good clinical practices
Essential documents in clinical research and regulatory requirements
Study setup process
QC, Compliance & Auditing in Clinical Research
Clinical Monitoring
Introduction of Pharmacovigilance
Medical Evaluation of Adverse Events in Pharmacovigilance
Case Processing
Pharmacovigilance Reporting Database, Signal Detection, Managements and Risk Assessments & Evaluation
Medical Dictionary for Regulatory Activities medDRA
PV laws and Guideline
*Fees subject to taxes & exchange rates.
*Fees subject to taxes & exchange rates.
Clinical trial management involves overseeing the planning, implementation, and completion of clinical trials. Managers coordinate various aspects including protocol development, participant recruitment, regulatory compliance, data collection, and communication with stakeholders, to ensure trials are conducted efficiently and ethically.
Clinical trial project management refers to the application of project management principles to clinical trials. It involves planning, organizing, and controlling resources and activities to achieve specific trial objectives with defined timelines and budgets.
To become a clinical trial manager, you will need a relevant educational background in life sciences, pharmacy, or a related field. You can also consider developing your project management skills by gaining field experience or pursuing certifications.
A clinical trial program refers to a series of interconnected clinical trials conducted to address a common research objective. It may involve multiple trials designed to evaluate different aspects of a treatment or intervention.
Yes, there is a significant scope for clinical trial management in India. India has now become a hub for clinical research due to our diverse patient population, skilled professionals, and cost-effective environments. This has brought numerous career opportunities for individuals interested in clinical trial management roles.
