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Clinical Research Training Institute Bangalore

Clinical Research Training Institute Bangalore

About Clinical Research Operations

India is one of the most sought after destination for clinical research activities. It is one of the most strategic locations for global pharmaceutical companies to conduct their drug research and development Apart from well known factors such as low cost, easy accessible to patients and English- speaking trained professional, India has become a well-known center for drug trials because of the ever increasing number of specialty hospitals, BA/BE units and world-class data-processing infrastructure and improving regulatory support. In India, in addition to clinical operations, i.e. Conducting and monitoring clinical trials, service providers known as CROs provide services in related areas such as clinical data management, Pharmacovigilance, medical writing, logistics and analysis.

GITS Academy provides you an innovative learning approach which allows you as a student to apply the theoretical knowledge and skills gained during the taught course in an effective manner in the clinical research industry.

Courses offered

PG Diploma in Clinical Research which consists of clinical research, clinical data management, clinical SAS and Pharmacovigilance training for 4 months, followed by a 3-month internship in one of the above fields.

Course Objective


Demonstrate an understanding and skills associated with:


Clinical research process
Planning a clinical trial
Preparing essential documents: Protocol, CRF, IB, ICD
EC & Regulatory submission
Trial Management
SAE Reporting
Trial Monitoring
Database design
Data Entry
Data Validation
21 CFR part 11

Hands on experience with Open Clinica


Base & Advance SAS
ICH E9
SAP
SAS Clinical
Drug Safety Terminology
Causality Assessment
Guidelines for PV – ICH, WHO
Regulations – US, EU perspective
Case Processing: Triage, Process, Report
Working with MedWatch, CIOMS Forms and literature sources
Aggregate reporting

Life science, Pharmacy, Medical Graduates & Post Graduates (including BDS, BAMS, BHMS, BPT)

The course duration is 6 months In- class sessions = 4 months Internship = 2 months

Yes, the internship will be provided at the end of the course for a period of two months. We, believe that by performing an activity, internship enhance your existing theoretical knowledge and improves your skills.

No. We cannot guarantee that a company will hire you as it is based on your performance during an interview. However, we do provide 100% placement assistance.

Yes. Each student is entitled to placement assistance. Our placement officer is dedicated towards finding a suitable opportunity for each student. We are proud to state within a short duration we have been successful in placing our students in the field of clinical operations as CRCs and process coordinators, as drug safety associates in Pharmacovigilance departments, QA personnel in medical writing departments and as Jr. SAS programmers. Students who have completed a course in clinical research from any other organization may approach us for internship assistance.

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Learning Objective:

Demonstrate an understanding and skills associated with –

  • Clinical research process
  • Database design
  • Data Entry
  • Data Validation
  • 21 CFR part 11 vHands on experience with Open Clinica

    Life science, Pharmacy , Medical Graduates (including BDS, BAMS, BHMS, BPT).

    The course duration is 4 months In- class sessions = 2 months Internship = 2 months

    Yes, Internship will be provided at the end of the course for a period of two months. We, believe that by performing an activity internship enhance your existing theoretical knowledge and improves your skills.

    No. We cannot guarantee that a company will hire you as it is based on you performance during an interview. However we do provide 100% placement assistance.

    Yes. Each student is entitled to placement assistance. Our placement officer is dedicated towards finding a suitable opportunity for each student. We are proud to state within a short duration we have been successful in placing our students in the field of clinical operations as CRCs and process coordinators, as drug safety associates in pharmacovigilance departments, QA personnel in medical writing departments and as Jr. SAS programmers. Students who have completed a course in clinical research from any other organization may approach us for internship assistance

Learning Objective:

Demonstrate an understanding and skills associated with –

  • Clinical research process
  • Planning a clinical trial
  • Preparing essential documents: Protocol, CRF, IB, ICD
  • EC & Regulatory submission
  • Trial Management
  • SAE Reporting
  • Trial Monitoring
  • Drug Safety Terminology
  • Causality Assessment
  • Guidelines for PV – ICH, WHO
  • Regulations – US, EU perspective
  • Case Processing: Triage, Process, Report
  • Working with MedWatch , CIOMS Forms and literature sources
  • Aggregate reporting

    Life science Post Graduates, Pharmacy, Medical Graduates & Post Graduates (including BDS, BAMS, BHMS, BPT)

    The course duration is 4 months In- class sessions = 2 months Internship = 2 months

    Yes, Internship will be provided at the end of the course for a period of two months. We, believe that by performing an activity internship enhance your existing theoretical knowledge and improves your skills.

    No. We cannot guarantee that a company will hire you as it is based on you performance during an interview. However we do provide 100% placement assistance.

    Yes. Each student is entitled to placement assistance. Our placement officer is dedicated towards finding a suitable opportunity for each student. We are proud to state within a short duration we have been successful in placing our students in the field of clinical operations as CRCs and process coordinators, as drug safety associates in pharmacovigilance departments, QA personnel in medical writing departments and as Jr. SAS programmers. Students who have completed a course in clinical research from any other organization may approach us for internship assistance.

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