CLINICAL RESEARCH
Clinical research is a comprehensive process of determining the safety and efficacy of a candidate product (vaccine, diagnostic, and therapeutic). Only those prospective compounds which have fared satisfactorily through the basic and the preclinical research phases are approved for clinical trials in humans, and a small number of those ones finally sail through the various phases and approvals involved in bringing the product to the market.
Clinical research is a branch of healthcare science that regulates the safety and effectiveness (efficacy) of medications, devices, diagnostic products, and treatment schedules proposed for human use. These may be used for prevention, treatment, diagnosis, or for relieving indicators of disease.
IMPORTANCE OF CLINICAL RESEARCH:
- New drug to market.
- A new approach for radiation.
- New methods of surgery.
- A new combination of standard treatments.
- A new technique like Gene therapy
- Improves diagnostic tools and preventive care
- Build scientific foundation clinical practice
- Strengthen our understanding of human physiology and pathophysiology
- Enhance end of life care and palliative care
SKILLS REQUIRED:
- Attention to detail.
- Scientific accuracy.
- Good communication and coordination with various people involved in the process.
- To use a well-planned search strategy relevant keywords and a reliable source.
- Know the target audience and write at a level appropriate to the target audience.
- Ability to understand the purpose and requirements of the project.
- Comprehensive writing skills with good command of English.
- Know basic about MS Excel, MS Word.
ELIGIBILITY:
Life science, MBBS, BDS, BPT, MPT, BSc, MSc, Biostatistics, Bioinformatics, B Pharm, M Pharm, Graduate’s, and Post Graduates.
PROGRAM STRUCTURE:
MODULE 1: INTRODUCTION TO CLINICAL RESEARCH
MODULE 2: NEW DRUG DEVELOPMENT
MODULE 3: DESIGNING CLINICAL TRIALS
MODULE 4: GOOD CLINICAL PRACTICE
MODULE 5: CLINICAL TRIAL PROTOCOL
MODULE 6: IRB/IEC
MODULE 7: GOOD CLINICAL DATA MANAGEMENT PRACTICE
MODULE 8: RESPONSIBILITIES OF SPONSOR AND INVESTIGATOR
MODULE 9: ICH GCP GUIDELINES
MODULE 10: MedDRA CODING
MODULE 11: BA/BE STUDIES
MODULE 12: REGULATORY AFFAIRS
MODULE 13: MEDICAL WRITING
MODULE 14: INTRODUCTION OF PHARMACOVIGILANCE
MODULE 15: INTRODUCTION OF SAS
MODULE 16: OVERVIEW OF INSPECTION AND AUDITS
MODULE 17: PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS
MODULE 18: LIVE PROJECTS BY INDUSTRY EXPERTS
Integrated Online Clinical Research Course
