Clinical Research (Theory)

Course Features

• Instructor Live Sessions

  There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
  
• Real-time Case Studies

  Live project based on any of the selected use cases on the above selected Domain. 
  
• Assignments

  Each class will be followed by practical assignments which can be completed before the next class.
  
• 24 x 7 Expert Support

  We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
  
• Certification

  Towards the end of the course, you will be working on a project. Covalent certifies you as an course Expert based on the project.
  

Course Curriculum

• Clinical Research

  Clinical Research-Topics:

  • Introduction to Clinical Research
  • INDA, NDA, ANDA applications
  • Types, Designs and Phases of Clinical Trials
  • ICH GCP guidelines (ICH E6)
  • Roles and Responsibilities of Investigator and CRA
  • Roles and Responsibilities of Sponsor and CRC
  • Contract Research Organizations-CRO
  • Case Report Form and its Contents with live example
  • Contents of protocol
  • Explanation of Research protocol with live example
  • Informed Consent Form
  • Institutional Review boards(IRB)/IEC
  • Participant safety and Adverse events reporting
  • Safety definitions and reporting requirements
  • Monitoring of Study at participating sites
  • Source Data Verification
  • Investigator's Brochure (IB)
  • Standard operating procedures
  • Essential documents
  • Data Coding using MedDRA and WHODD
  • CRF Design Guidelines
  • SAE/AE Reconciliation

   

   

Projects

• Clinical Research Project

  We will give Clinical Research Real Time scenarios.

FAQ's

• Can I attend a demo session before enrollment?

  Yes

• What if I miss a class ?

   If you miss a class we can provide recording video for particular session or we can arrange you the back up session.

• Will I get placement Assistance ?

  Yes

• Do I receive a certificate for training ?

  • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
  • Covalent certification has industry recognition and we are the preferred training partner for many MNCs

• What support is available after the training?

  Doubts clarification up to getting a job

  Resume preparation

  Mock interviews

  Placement Assistance

• What Features do you provide?

  Class Room & Online Live sessions
  Real time projects
  Working faculties 
  Lab facilities
  Placement assistance
  Resume preparation
  Doubts clarification

Certifications

• Course Completion Certificate

  • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
  • Covalent certification has industry recognition and we are the preferred training partner for many MNCs