Clinical Data Management
Clinical data management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management assures collection, integration and availability of data at appropriate quality and cost.
Students Trained so far
Instructor Led Program
Industrial Case Study
Customized Tracks For Better Results
Week I, II
You will be introduced to the Clinical Data Management.
Introduction to Drug Discovery & Clinical Trial
Week III, IV
CDM Process Overview
Different Documents in CDM
Study Set up
Study Close Out
Career Advancement Support Plus
By the end of the program, we will assist students to design their persona and resume required to represent them self in industry.
Top skills you will learn
Participant will be undergoing 10 modules, which covers case studies and all the concepts of medical clinical research as mentioned in the syllabus.
After completing the course you will be getting placement assistance and completing the mock interviews scheduled by the instructor.
Who can enroll for this programs ?
Students or Freshers from Pharma background looking to up-skill and become industry ready with the help of our verified instructors.
Student or fresher pursuing his/her career in the domain of pharma and medicine.
Syllabus & Modules
Our curriculum suits the requirement of the industry
1. Introduction to Drug Discovery & Clinical Trial
2. ICH-GCP Guidelines
3. 21 CFR Part 11
4. CDISC and SDTM
5. Regulatory Bodies
6. CDM Process Overview
7. Different Documents in CDM
Study Set up
- Site Planning and Initiation
- Role of Site Coordinator (CRC) and Monitor
- Database and eCRF Designing
- Edit Checks Programming (Front End and Back End)
- User Acceptance Testing (UAT)
- Database Validation
- Data Entry
- Discrepancy Management (Listing Review, Query Management and Reconciliation)
- QA/QC of Data
Study Close out
- Locking and Freezing of Data
- Extraction of Data sets to Stats
- Archival of Documents
- Office etiquettes
- Presentation skills and Public speaking
- Interview preparation
- CV preparation
- Mock interviews
What Our Students Have to Say
Meet Our Instructor
Clinical Data Personnel currently working at one of leading industrial organization. Ensuring that
data for clinical trials is properly collected and validated.Excellence track record when it comes to
consistent quality and reliability in carrying out research duties according to regulatory guidelines.10+
years in CDM.