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Gratisol Labs is a leading resource consulting services organization for the Pharmaceutical, Biotechnology and Medical Device industries. We offer contract and permanent job opportunities within the Pharmaceutical, Biotechnology and Medical Device industries to both experienced professionals and entry level candidates.
Gratisol Labs Advantages:
• 4 months internship available after training in Hospitals & CROs
• Own CRO live projects
• Highest Placement record across all training institutes
• Industry SOPs based training
• Trainers with minimum 5 years experience
• 24 hours access to application lab
The focus of the lectures will be mainly on the following topics:
This course focuses on the essential principles of Clinical Research and standard regulatory controls necessary to study the safety and efficacy of a drug. The course content has been reviewed and approved by Clinical research experts and academicians where more emphasis is laid on Planning, conducting, monitoring and generating information as per global standards and regulatory requirements. Students are not only trained in Clinical Research but there is a special focus given to Management & Soft Skill learning.
This course will provide training in the core competencies in clinical research including fundamentals of clinical trials. It's a great program for industry professionals who are looking to advance their careers or seeking industry certifications and anyone looking to enter the clinical research industry.
Clinical Research Industry Oriented Training Syllabus:
Certificate Course in Clinical Research
CLINICAL RESEARCH CONCEPTS, GUIDELINES AND REGULATIONS
• Introduction to Clinical Research.
• Pre-Clinical Research
• Drug Development Process
• Ethics In Clinical Research
• ICH-GCP Guidelines
• Schedule Y/NDA/ANDA
• FDA
• Phase I - IV, Post Marketing Surveillance
CLINICAL RESEARCH OPERATIONS
• Clinical Trial Design
• Protocol Design and Format
• Case Record Form
• Clinical Trial Supplies and Management
• Feasibility Studies
• Essential Documents and Trial Master File
• Archiving and Record Keeping
• Informed Consent
• Investigator Selection
• Investigators Meetings
• Roles and Responsibilities Of Players In Clinical Research(Sponsor, Investigator, Monitor, Stastician, Project Manager)
• Site Management
• Conduct Of A Study
• Pharmacovigilance
• Report Writing
• Publication
• Data Management
• Project Management
• Pharmacoepidemology
• BA/BE Studies
• Pharmaeconomics
• Central Laboratory
• Pharmacovigilance
• Outsourcing CR Projects
• Expanded Access Programs
• Patient Recruitments
• Audits And Inspections In CR
• Fraud And Misconduct In CR
• Communication Skills Required For Effective Monitoring.
• Liability And Indemnity In Clinical Research
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