Clinical Research

ELIGIBILITY

Candidates who are currently pursuing or have completed following curriculum are eligible for enrolment:

1. B.Pharm, M.Pharm, PhD
2. MBBS, MD, DNB, DM
3. BDS, MDS
4. BAMS, BHMS, BUMS
5. BPT, MPT
6. Life Sciences: B.Sc, M.Sc, Biotechnology
7. Working Professionals

COURSES

1. Post Graduate Certificate in Clinical Research (PGCCR)- 6 months

Program Highlights

• Self-learning study modules
• Assignment based evaluation
• Self-paced schedule (1-6 months)
• Optimal course fee
• Industry-wide recognition
• Placement assistance 
• Successful participants employed across 300+ organizations

2. Post Graduate Diploma in Clinical Research  (PGDCR) -1 year

Program Highlights

• Self-learning study modules
• Video lectures
• Assignment based evaluation
• Self-paced schedule (1-12 months)
• Optimal course fee
• Comprise of four high quality study modules
• Industry-wide recognition
• Senior industry experienced faculty
• Clinical Trials end to end | Regulations | Essential Documents |GCP | Monitoring | QA | Pharmacovigilance end to end |Regulations | Case Processing | Medical Review | Aggregate | Signal
• Project work
• Assignments for final assessments.
• Final online theory examination
• 100 % placement assistance  11000+ Placements
• Successful participants employed across 300+ organizations

3. Post graduate certificate in pharmacovigilance  (PGCP)- 6                     months

Program Highlights

• Self-learning study modules
• Assignment based evaluation
• Self-paced schedule (1-6 months)
• Optimal course fee
• Industry-wide recognition
• Placement assistance 

4. Post graduate certificate in scientific writing (PGCSW) – 6                      months

Program Highlights

• Self-learning study modules
• Assignment based evaluation
• Self-paced schedule (1-6 months)
• Training topics
  • Introduction to Clinical Research
  • Evolution of Ethical Research Principles, Regulations and Guidelines
  • Clinical Study Process
  • Development of Standard Operating Procedures (SOPs)
  • Protocol
  • Informed Consent Document (ICD)
  • Clinical Report Form (CRF)
  • Data Validation Plan (DVP)
  • Clinical Study Report (CSR)
  • Publication
• Placement assistance 

5. Post graduate certificate in project management (PGCPM) – 6              months

Program Highlights

• Self-learning study modules
• Assignment based evaluation
• Self-paced schedule (1-6 months)
• Training topics
  • Introduction to Clinical Research
  • Evolution of Ethical Research Principles, Regulations and Guidelines
  • Project Milestones Planning and Forecasting
  • Cost Estimate and Financial Planning
  • Logistics Planning, Vendor Selection and Management
  • Clinical Study Process (multi-centric) and Creation of Trial Master File(s)
  • Management of Regulatory Document Submission
  • Co-ordination of Individual Site Set-up Activities
  • Import/ Export Authorization
  • Organization of Investigator Training Meeting
  • Study Initiation, Conduct and Milestones Tracking
  • Audit(s) and Quality Assurance
  • Study Closeout (trial completion, suspension, termination etc.)
• Placement assistance 

6. Post graduate certificate in clinical trial monitoring (PGCCTM)– 6 months

 Program Highlights

• Self-learning study modules
• Assignment based evaluation
• Self-paced schedule (1-6 months)
• Training topics
  • Introduction to Clinical Research
  • Evolution of Ethical Research Principles, Regulations and Guidelines
  • Clinical Study Process
  • Investigator Site Selection/Assessment
  • Development of Monitoring Plan
  • Site Initiation, Review of Essential Trial Documents, Delegation of Duties
  • Clinical Trial Monitoring
  • Inventory Planning and Tracking
  • Source Document Verification (SDV)
  • CRF Review, Collection and Co-ordination of Data Management Activities
  • Escalation, Management and Prevention of Violations/Deviations
  • Tracking of Enrolments, Payments and Ongoing Correspondence
• Placement assistance 

7. Post graduate certificate in Oncology Clinical Trials Training 

Program Highlights

• Self-learning study modules
• Assignment based evaluation
• Self-paced schedule (1-6 months)
• Training Modules
  • Fundamentals of Oncology Clinical Trials
  • Oncology Clinical Trials Monitoring
  • Dummy Clinical Trial Monitoring 
• Placement assistance 

8. GCP Training Workshop

 Program Highlights

• A one-day workshop-based training program aimed at imparting skills on clinical research, drug development process and Good Clinical Practice guidelines
• Live Lectures on important topics such as:
  • New Drug Discovery Process and Clinical Research
    Drug discovery process, pre-clinical development, clinical research, clinical trial phases, stakeholders, critical success factors etc.
  • Foundation to Good Clinical Practices (GCP) Guidelines
    Principles of GCP, applicable GCP guidelines, evolution of GCP guidelines and responsibilities of various stakeholders (Sponsor, CRO, Investigator and Ethics Committee) etc.
  • Essential Clinical Trial Documents
    Protocol, Informed Consent Document (ICD), Investigator’s Brochure (IB), Case Record Form (CRF), Source Data/Document (SD) etc.
  • Overview of Informed Consent Process
    Purpose, process requirements, essential elements, format, procedure etc.
  • Serious Adverse Event (SAE) Reporting and Compensation
    Adverse event, valid case, regulatory definition of serious criteria, reporting timeframe and recommendations for determining compensation for study related injuries
  • Regulatory Landscape
    Types of applications, data requirements, New Drugs and Clinical Trials Rules (2019), National Ethical Guidelines for Biomedical and Health Research Involving Human Participant (2017) etc.
• Certificate of Participation awarded to the participants on successful completion

9. 21 CFR Part 11 Training workshop

Program Highlights

• A one-day workshop-based training program aimed at imparting knowledge and skills on 21 CFR Part 11 regulations
• Focus Area:
  • 21 CFR Part 11 Electronic Records; Electronic Signatures
  • Electronic Data Capture in Clinical Trials (EDC)- The Auditor’s View
  • Case Studies
  • Group discussions, Team Exercise
• Certificate of Participation awarded to the participants on successful completion

10.Post graduate certificate in clinical data management                              (PGCCDM)

                       VIDEOS