Advanced Certification Course in Clinical Research & Clinical Data Management
Acquire top-demand skills in clinical trials and IT data systems with our 6-month Advanced Certification Course in Clinical Research & Clinical Data Management (CDM). Learn EDC study setup, query management, data cleaning, CDISC standards, and medical coding systems through live interactive online classes. Features hands-on practice, 3 Industry-Recognized Certifications, STAR interview preparation, ATS resume building, and 100% assured placement support.
Why Choose Clinidea Education?
Clinidea Education specializes in clinical database and operations training. Our placement-oriented data management program is built around standard CRO operations, emphasizing:
Practical Workflow-Based Learning
We ensure you understand the entire database design, data cleaning, and validation workflows that data managers execute daily.
Drug Development & Trial Workflows
Understand the clinical trial phases, drug discovery processes, and site operations.
CDM Lifecycle & Study Setup
Master DMP development, CRF designing, and database setup in EDC tools.
CRF Designing & EDC Systems
Practice Electronic Data Capture system setup, screening logs, and forms validation.
Data Validation & Query Management
Write edit checks, perform data cleaning, open/resolve discrepancy queries, and issue queries.
Medical Coding Dictionary Standards
Apply MedDRA and WHO Drug Dictionary coding standard terminology to adverse events and medicines.
Regulatory Compliance & Audit Readiness
Understand 21 CFR Part 11 standards and data security guidelines to prepare for audits.
Course Curriculum & Modules
Clinical Research
- Drug discovery process & clinical trial phases (Phase I–IV)
- ICH-GCP guidelines, FDA regulations & ethical compliance
- Clinical trial design, protocol development & amendments
- Essential documents: Protocol, Investigator Brochure (IB), ICF
- Clinical site selection, initiation & feasibility studies
- Trial monitoring, site management & patient recruitment
- Ethics committee submissions & regulatory approvals
- Trial documentation, TMF management & audit readiness
Clinical Data Management (CDM)
- Clinical Data Management lifecycle & study setup
- Case Report Form (CRF) design & data capture systems (EDC)
- Data validation, discrepancy management & query resolution
- Edit checks, data cleaning & database integrity checks
- Medical coding using MedDRA & WHO Drug Dictionary
- SAE reconciliation & external data handling
- CDISC standards (SDTM, ADaM) & database lock process
- Regulatory compliance (21 CFR Part 11) & audit readiness
Career Outcomes & Benefits
Clinical Research Associate
Audit trial documentation, monitor site operations, and maintain GCP standards.
Clinical Data Manager
Oversee the entire data management lifecycle from study build to database lock.
Clinical Data Coordinator
Perform data entry validation, run edit check validations, and manage discrepancy queries.
Medical Coder (CDM)
Translate trial event reports into standardized codes using MedDRA and WHO-DD.
ATS-Optimized Placements
Access one-on-one resume formatting, LinkedIn building, mock calls, and corporate referrals.
3 Industry Certifications
Boost your CV with Course Completion, GCP, and Practical Internship certificates.
Program Details
Duration
6 Months Intensive Training
Mode
Online (Live Interactive)
Eligibility
B.Pharm, M.Pharm, PharmD, BSc, MSc, BTech/MTech (Biotech), BDS, MDS, BHMS, BAMS, MBBS & Life Science Aspirants.