Course Duration in Hours
60
60
Courses Offered:
Clinical Data Management
SDTM (CDISC)
SAS Programming (Clinical)
SAS Clinical projects
Internship Programs on Clinical Data Management, SAS, SDTM
Job Assistance:
Extensive Placement support would be provided to the successful candidates.
Course Content:
Phase Trials1,2,3,4
ICH-GCP
Clinical Trial Process
BA,BE Studies
Responsibilities of Clinical Research Persons
PK,PD
CTMs
Regulatory Bodies(FDA,IRB,NDA)
Clinical Research Documents
Clinical Data Management(Especially Present Industry Expected)
protocol
understanding Of Protocol
Electronic CRF Designing
Edit Check Programming
Edit Checks Implementation
Data Base Design
Data Validation
Data Base Setup
Data Cleaning
QC and QA
UAT Process
CDM Foundation
Importance of CDM
21 CFR 11
Clinical Data Data Management Process
GCDMP
EDC (Electronic Data Capture)
EDC Plan
DMp
Pharmacovigilance
SAS programming
Base sas
and Advance Sas
MBBS, BDS, BHMS, BAMS, BPT,B. Pharmacy,M.Pharmacy, Graduate/Post Graduate Degree in Life Sciences, ,Pharmacology, Pharmacy, Medical Laboratory, Nursing, Biochemistry, Microbiology, Biotechnology and all professionals working with Pharmaceutical companies, CROs and Hospitals.
Lara Tech, Ameerpet (Hyderabad),Hyderabad,IN