CROC-P

Certificate course in “Fundamentals of Clinical research & its basic Methodology”

     The course specifically designed for the students those are new to the field and want a thorough introduction of clinical research as well as clinical trials procedure. This course is a bird eye view of the whole industry and after taking this course you will be able to find that where you can fit in yourself in this field. This course contains following listed topics

• Introduction and Overview on Clinical Research & Clinical Trials
• History of Clinical Research
• Helsinki Declaration
• General Pharmacology
• Drug Development Process
• Clinical Trial Design
• Fundamentals of Monitoring and Site Management
• General Terms and Abbreviations
• Final Assignment

Certificate course in “Clinical Data Management & Analysis”

     Massive amount of data is generated during a clinical trial and to handle this data skilled minds are required. Through this course you will come to know the sources of data generation in a trial and how to manage and analyze it effectively to search out the better solutions to the medical field. Basic understanding of the data technologies will be an added advantage to set you in the industry. The course comprises following topics.

• Introduction and Overview on Clinical Research & Clinical Trials
• Overview about Clinical Data Management
• Clinical Trials Protocol
• Case Record From Design 
• Trial Master File
• Data Management  
• Electronic Data Capture
• Statistical Analysis for Clinical Trials
• Outsourcing in Clinical Research
• Final Assignment

Certificate course in “An Insight to Good Clinical Practice & Regulatory Affairs in Clinical Research“

     An important aspect in a trial is ethical issues and proper documentation and design of the trial. The career avenues related with GCP and Regulatory affairs hold the very important place. This course gives you deep understanding of the standard guidelines proposed by FDA addressing ethical issues to design, conduct, regulate and document a trial safely and properly.

• Introduction and Overview on Clinical Research & Clinical Trials
• ICH - GCP Guidelines
• Schedule Y
• Indian GCP Guidelines
• Clinical safety & Pharmacovigilance
• Indemnity & Liability in Clinical Trials
• Fraud and Misconduct in Clinical Trials
• Audit and Inspection
• Quality Control and Quality Assurance
• comprehensive overview of the regulatory requirements for carrying out clinical trials
• Develop effective processes for obtaining Clinical Trials Authorization: Regulatory Approval and Ethical Approval
• legal aspects of clinical trials
• Recent developments in clinical trial regulations including FDA requirements
• Final Assignment

Certificate course in “Medical writing & documentation for clinical research”

     The most important in a clinical trial is presenting the study to the authority or officials in a well documented manner with proper use of scientific terminology. This course will help to set you in this most demanding career in various pharmaceutical companies. It also gives you stand as a freelance/ e-lance medical writer.

• Introduction and Overview on Clinical Research & Clinical Trials
• What is Medical Writing?
• Documents created by the medical writers for a clinical trial:
• Standard Operating Procedures (SOPs)
• Protocols
• Investigator Brochures
• Case Report Forms
• Informed Consent Documents
• Educational and Training Material for the Study Staff
• Pre Clinical Scientific Reports
• Clinical Trial Reports/Study Reports
• Applications
• Documentation of Research for Regulatory submission
• Drug Marketing Literature and Brochures
• Ethics in Clinical Trials
• Regulatory Affairs
• Project Management
• Principles of Pharmaco-economics
• Introduction to Pharmacogenomics/Pharmacogenetics driven Clinical Trials
• Introduction to Clinical Data Interchange Standards Consortium (CDISC)
• Business and administrative Aspects & Clinical Research
• Final Assignment

“Advanced Diploma Course in Clinical Research” ADCR (Online Mode)

     ADCR diploma available through online and distance mode both is a good choice if you are interested right from the beginning to the end of the picture of a clinical trial. This enhances your chances to get in from a beginner level such as CRC, CRA to the expert level entries.