Clinical Research Online Training

Clinical Research is the scientific study of the safety and effectiveness of medical treatments, drugs, and devices before they are released to the public. This training program provides a complete understanding of clinical trial processes, regulatory guidelines, ethical principles, data management workflows, and pharmacovigilance practices used in the pharmaceutical, biotech, and healthcare industries.

Our course blends theoretical knowledge, industry SOPs, and real case study discussions, preparing participants for roles in Clinical Operations, Clinical Data Management (CDM), Pharmacovigilance (PV), Drug Safety, and Regulatory Compliance.

Clinical Research Training Course Details

Training Highlights

Live Instructor-Led Online Sessions
Real-Time Case Studies & Industry Documentation
Interview and Resume Preparation Support
Certification Guidance (ICH-GCP / Clinical Research Certificates)
Access to Recorded Sessions, Notes & Study Material

Course Curriculum

Module 1: Introduction to Clinical Research
- What is Clinical Research?
- Pharmaceutical Industry Overview
- Key Terminologies & Stakeholders (Sponsor, CRO, Site, Ethics Committee)
- Drug Development Lifecycle
Module 2: ICH-GCP Guidelines
- History & Need of GCP
- Principles of ICH-GCP
- Roles & Responsibilities: Investigator, Sponsor, Monitor, Ethics Committee
- Essential Trial Documentation
Module 3: Clinical Trial Phases & Study Design
- Phase I, II, III, IV Trials
- Randomization, Blinding, Placebo Concepts
- Protocol Design & Case Report Forms (CRF)
- Subject Recruitment, Screening & Informed Consent
Module 4: Regulatory & Ethics
- Institutional Review Board / Ethics Committees
- Regulatory Authorities: FDA, EMA, CDSCO
- IND, NDA, ANDA Submissions
- Safety Reporting Procedures
Module 5: Clinical Operations
- Site Identification & Initiation
- Study Monitoring & Source Data Verification
- Query Management & Data Cleanup
- Deviation Handling & Risk-Based Monitoring
Module 6: Pharmacovigilance (Drug Safety)
- Introduction to Drug Safety
- Adverse Events & Serious Adverse Events (SAE)
- AE Case Processing Workflow
- Narrative Writing & MedDRA Coding
- Periodic Safety Update Reports (PSURs)
Module 7: Clinical Data Management
- Data Collection & CRF Design
- EDC Systems (e.g., Oracle Inform, Medidata Rave) Overview
- Database Lock, Data Validation, Query Management
Module 8: Quality Assurance & Audits
- Clinical Trial Auditing & SOPs
- CAPA, Root Cause Analysis
- Compliance & Inspection Readiness
Module 9: Final Project + Interview Preparation
- Real Study Documentation Review
- Mock Trial Monitoring Exercise
- Resume Building for CRA / CRC / CDM / PV Jobs
- Interview Q&A Discussion

Career Paths After Training

Clinical Research Associate (CRA)
Clinical Research Coordinator (CRC)
Drug Safety Associate / Pharmacovigilance Executive
Clinical Data Management Specialist
Regulatory Affairs Associate

Who Should Join

Life Science, Pharmacy, Nursing, Biotechnology, Medical Graduates
Clinical Data Management / Drug Safety Aspirants
Pharmacists, Healthcare Professionals, Research Coordinators
Freshers seeking entry into Pharma and Clinical Research organizations

Prerequisites

Background in Life Sciences / Pharma / Nursing is helpful but not mandatory
No prior clinical trial experience required

Why Choose Best Online Trainers?

Instant Access: Get instant access to self-paced training after signup.
Streaming video recording: Watch lessons any time at your schedule, free recording.
Exercises: Practical exercises help you test what you are learning as you go.
Free Demo: Sign up for free demo to check whether the course is right for you and interact with the faculty live.
Experienced Trainers: We only hire the industry’s best trainers
Live free interactive web sessions: Ask questions and clarify your career prospects any time after you complete the course.
Structured Curriculum Schedule: Progress with complete daily interactive lessons and assignments.
Faculty Mentoring: Turn in daily and weekly homework for personalized feedback from faculty.
Virtual Office Hours: Live interaction with the faculty and other students around the world.
Hands on Live Projects: Work on real-world projects with 100% faculty guidance and ratings.

Trainer Profile

Experienced Clinical Research professionals
10+ years of industry and academic background
Expertise in GCP, regulatory, CDM, PV, and site management
Mentoring for certification and job placement in Pharma/Healthcare

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Client Feedback

Thanks, you guys provided the best online training in SAP BODS. The hands on training is very informative and helpful.

- David Sergi, Camaga Ltd; U.K