About Our Clinical Research Course
Clinical research plays a vital role in advancing healthcare and developing new medical treatments. It is a backbone of medical advancement where every new drug, vaccine or treatment protocol must pass through the structured clinical trials before it reaches the patients. So, this has become the rising global demand for qualified clinical research professionals.
At Resolve Medicode, we offer comprehensive clinical research course designed to stimulate students, healthcare professionals and life science graduates with knowledge and skills needed to thrive in the growing field of clinical trials and research. This course is structured to provide a balance of theoretical knowledge and practical exposure. Whether your starting your career in clinical research or looking to upskill, this program prepare you the real world challengers in clinical research and in regulatory environments. We offer clinical research certification for individuals who are passionate about contributing to medical science and improving patient care through evidence-based research and ethics.
Who can Enroll?
- Medical, Pharmacy, Nursing graduates
- Life Science and Biotechnology students
- Working Professionals in healthcare or pharma industry
Our Course Modules:
1: Introduction to Clinical Research
Definition and purpose of clinical research
History and evolution of clinical trials
Overview of the drug development process
Phases of clinical trials (Phase I–IV)
Types of clinical research (interventional, observational, epidemiological)
2: Ethical Guidelines & Good Clinical Practice (GCP)
ICH-GCP principles and structure
Declaration of Helsinki
Belmont Report
Informed consent process and patient rights
Ethics committees/IRBs: role and responsibilities
3: Regulatory Affairs
Key global regulatory authorities:
FDA (US), EMA (EU), CDSCO (India), MHRA (UK), PMDA (Japan)
IND, NDA, ANDA, CTA, and BLA submissions
Overview of regulatory pathways and approvals
Regulatory documentation and timelines
4: Clinical Trial Protocol and Design
Elements of a clinical trial protocol
Study objectives, endpoints, and inclusion/exclusion criteria
Randomization and blinding
Study design types (parallel, crossover, open-label, etc.)
5: Roles and Responsibilities
Investigator and site staff
Clinical Research Associate (CRA)
Clinical Trial Coordinator (CTC)
Sponsor and Contract Research Organization (CRO)
Data Safety Monitoring Board (DSMB)
6: Site Management and Monitoring
Site selection and feasibility
Investigator site file (ISF) setup
Initiation, monitoring, and close-out visits
Source data verification (SDV) and site audits
Common site challenges and resolutions
7: Clinical Trial Operations
Subject recruitment and retention
Enrollment logs and screening failures
Drug accountability and IP management
AE/SAE reporting and documentation
Trial master file (TMF) management
8: Data Management and Biostatistics
Overview of clinical data management (CDM)
Case report forms (CRFs) and electronic data capture (EDC)
Data cleaning and query management
Basic statistical concepts: p-value, confidence interval, mean, median
Role of biostatistics in clinical trial analysis
9: Safety Reporting and Pharmacovigilance
Adverse events (AEs) and serious adverse events (SAEs)
Causality assessment and reporting timelines
Safety databases and MedDRA coding
Signal detection and periodic safety reports (PSUR, DSUR)
10: Quality Assurance and Audits
Importance of quality control and assurance in trials
Internal audits vs. regulatory inspections
Common findings and CAPA implementation
Audit trails and documentation best practices
11: Clinical Trial Documentation
Essential documents (ICH E6 guidelines)
Informed consent forms, CRFs, ISF, TMF
Investigator Brochure (IB), Clinical Study Report (CSR)
Documentation for regulatory inspection
12: Career Development & Certification Exam
CV preparation and interview training
Roles in clinical research industry: CRA, CRC, CTA, CDM, PV
Mock assessments and project work
Overview of certifications: ACRP, SOCRA, DIA, ICH GCP training
Final course assessment and certification
Why choose us for Clinical Research Course?
Industry Relevant Curriculum: Our course is designed in consultation with experts from clinical research organisations and pharmaceutical companies. We focus on real world skills and knowledge that match the current industry demands for our candidates
Trained Professionals: You will learn from our trained faculty who has hands on experience in clinical trials, monitoring, drug safety and documentation process. They share their practical insights and case-based teaching approach help our candidates to gain theoretical and practical knowledge.
Flexible Learning and Duration: For working professionals, students and graduates we offer live classes, recorded classes and self-paced recorded modules based on their needs. We offer 45 days course duration for our candidates.
Globally Recognized Certification: After successful course completion you will receive the clinical research certification which adds credibility to your career and accepted by the clinical research companies and hospitals in India and abroad.
Placement Support: Our job focused training helps to access the job openings through our placement network for our candidates.
