Clinical Research Operations

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Clinical Research Operations

Clinical research is a branch of the pharmaceutical industry that evaluates and confirms the safety and efficacy of medications, devices, diagnostic products, and treatment regimens intended for human use. This research has an impact on products/molecules reaching the pharmacy outlets. Clinical Operations teams are responsible for designing, planning, and physically running Phase IV clinical trials within the drug discovery industry.

Objective



  • Train research professionals and equip them with the critical skills needed to practice clinical research.
  • Teach, promote, and apply scientifically valid and ethically sound principles of research.
  • Collaborate with Industry leaders in giving hands-on experience and thus acquire expertise.
  • Make students job-ready by providing the environment for inter-phase and optimum placement assistance to all the students.



Curriculum/Services

We train in Clinical Research Operations by providing a well-versed curriculum which us inclusive of:

Introduction to Clinical Research


  • Definitions and types of CR Phases of Clinical Trials.
  • Overview of CR processes.
  • Opportunities in CR.
  • Career Development in CR.
  • Performance evaluation.




Contract Research Organization (CRO)


  • CRO-Organization, Structure, Role, Responsibilities, Costing, Contracts and Agreements—CDA, CTA.
  • Performance evaluation.




Overview of Clinical Research Documents


  • Definition of SOPs and Source Documents.
  • Clinical Study Plans.
  • Informed Consent Form Case Record Form.
  • Investigator Brochure
  • Performance evaluation.




Roles and Responsibilities


  • Sponsor.
  • Principal Investigator.
  • Institutional Review Board / Ethics Committee.
  • Performance evaluation.




Guidelines


  • ICH GCP –Good Clinical Practice.
  • White Paper Presentation
  • Performance evaluation.




Clinical Trial Procedures


  • Budgeting.
  • Clinical Trial protocol Preparation.
  • Investigator Meeting.
  • Site Initiation Visit.
  • Site Monitoring Visit.
  • Site Close Out Visit
  • Performance evaluation.




Regulations


  • Indian Forms as per CDSCO-# 44, 45, 12, 11.
  • US-Forms #1571, 1572, 3454, 3455.
  • US FDA Regulations- 21 CFR part 50, 54, 56, 312, 314.
  • EU-EMEA, Australia-TGA, UK-MHRA, Canada-HPFB, JapanPMDA.
  • Performance evaluation.




Adverse Events Form


  • All CR related Forms-AE, SAE, Subject ID code list, Staff Delegation log, etc.
  • Performance evaluation.




Audits and Inspections


  • All CR related Forms-AE, SAE, Subject ID code list, Staff Delegation log, etc.
  • Performance evaluation.




Requirements

If you are from any of the below qualification backgrounds, then you can begin a career in Clinical Research Operations.

  • Pharmacy (B. Pharm, M.Pharm, D.Pharm)
  • Life Sciences (B.sc, M.sc)
  • Medicine (BDS, MDS, MBBS, M.D,M.S,MCh)
  • Alternative Medicine (AYUSH)
  • Nursing (B.Sc,M.Sc)
  • Physiotherapist .
  • Healthcare industry personnel
  • PhD

If you think you could be a clinical analyst, then we are here to guide you.

Download the course pdf for a detailed understanding before you begin your Clinical Research Operations training with us!