Advanced Certificate Course in Clinical Research

Clinical Research is a branch of healthcare science that has started way back and now emerging as the core pharma field that is providing abundant career opportunities through in-house pharma companies as well as through outsourced projects. Clinical research involves the very basic steps right from the drug development until the regulatory submission processes and the ethical principles driving the whole conduct of the trials on the human population. It also deals with the documentation that is required for a smooth flow of the clinical trials as well as monitoring and closeout of the trials.

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Course Details

Course Validity: 1 Year

Course Fee: 30,000 INR + GST (SAS Alone)

Other Course Options: This course can be taken in combination with other courses like Regulatory Affairs & Clinical Data Management and or Pharmacovigilance.

Who Can Learn?

Graduates and postgraduates from pharmacy and life sciences,

MBBS

BDS

BHMS

BAMS

Pharm. D

What You'll Learn?

The Clinical Research syllabus is vast, but it typically involves the below mentioned major topics such as;

  • Drug development process
  • Historic events lead to ethical conduct of clinical trials
  • Regulatory bodies and regulations
  • ICH-GCP guidelines and principles
  • Essential Documents
  • Roles and responsibilities of stakeholders
  • Glossary of terms
  • Site-related activities
  • Ability to understand the purpose and requirements of the project
  • Ability to write at a level appropriate to the target audience
  • Thorough research of the subject
  • Ability to think, logical organization of thoughts and ideas
  • Scientific accuracy
  • Attention to details
  • Ability to work across teams (often remotely) as well as independently
  • Good communication & coordination with various people involved in the process
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