Introduction to CDM Process
Data Management Plan
EDC (Electronic Data Capture)
CRF Design (Paper)
e-CRF Development
Data Validation and Specification (DVS) Development
CDM QC Testing
CDM UAT Testing
Data Processing
Report generation and data transfer
Data Cleaning
Study freezing and Locking
Open Clinica (Comprehensive theory and Practical)
Oracle clinical, RAVE (Overview)
Extensive Overview of INFORM
Introduction to MEDRIO
SOP Development on CDM
Overview of Pharmacovigilance
Regulatory aspects in Pharmacovigilance
Periodic Safety Update Repors (PSUR’s)
Suspected Unexpected Serious Adverse Reactions (SUSAR’s)
Case report processing
Eudra Vigilance
Signal detection process and tools
Safety Intelligence
Overview of Pharmacovigilance S/W
Clinical Research and CDM.
Clinical Database Programing.
Clinical Research and SAS.
Clinical Research and Pharmacovigilance.
Clinical Research and Medical & Regulatory Writing.
Clinical Research, CDM and SAS.
Post Graduate Diploma in Clinical Research & Clinical Data Management.
Good Stuff Happens in 1:1 Meetings: Why you need them and how to do them well
Clinical Data Management & SAS Training In Hyderabad With SDTM
1. Clinical Data Management, SAS Programming Training& Intern ShipProgram
we understandyour need for the educational programwhichis of shorter
durationyet effective andjob oriented, andprovides withyou with the excellent
job opportunityat the same time. Intoday's competitive world the time is only
most important resource.
LARA Research offers wide range of Clinical Data Management & SAS training
programs designedprimarilyfor the students oflife sciences, Biotechnology,
Statistics, Pharmacy, Clinical researchand allied Health professions. Program
wouldbe invaluable to professionalsenteringthe Pharmaceutical, Biotechnology
and contract research companies, whowishto gainthe broader understanding of
Clinical Data Management, Studydesign, Data management plan, Research
methodology, Statistical analysis, Interpretation inclinicaltrialsandmanymore
topics.
Courses Offered:
Clinical Data Management
SDTM(CDISC)
SAS Programming (Clinical)
SAS Clinical projects
InternshipPrograms on Clinical Data Management, SAS, SDTM
ELIGIBILITY:
MBBS, BDS, BHMS, BAMS, BPT,B. Pharmacy,M.Pharmacy, Graduate/Post
Graduate Degree in Life Sciences, ,Pharmacology, Pharmacy, MedicalLaboratory,
Nursing, Biochemistry, Microbiology, Biotechnologyand allprofessionals working
with Pharmaceutical companies, CROs and Hospitals.
Job Assistance:
Extensive Placement support wouldbe provided to the successful candidates.
For more information,
Course Content:
Phase Trials1,2,3,4
ICH-GCP
Clinical Trial Process
BA,BE Studies
Responsibilities ofClinical Research Persons
PK,PD
CTMs
RegulatoryBodies(FDA,IRB,NDA)
Clinical Research Documents
Clinical Data Management(EspeciallyPresent IndustryExpected)
protocol
understanding Of Protocol
Electronic CRF Designing
2. Edit Check Programming
Edit Checks Implementation
Data Base Design
Data Validation
Data Base Setup
Data Cleaning
QC and QA
UAT Process
CDM Foundation
Importance ofCDM
21 CFR 11
Clinical Data Data Management Process
GCDMP
EDC(Electronic Data Capture)
EDCPlan
DMp
Pharmacovigilance
SAS programming
Base sas
and Advance Sas
Training Benefits
After CompletionOf Training We Will Give Training Certification
and Placement Assistance
Hands-onPractical expon Inform Architect,Central Design(Inform)
Real Time Scenarios
IndustryFaculties
24 Hours Lab Flexibility
This Course mainlyBeneficial to PharmacyStudents, B.Sc,M.sc Life Science
Students andMedicine Professionals
Lara Technologies(AcademyOf Clinical Research)
suite:#211,Nilgiriblock,Aditya Enclave,Ameerpet
Hyderabad-500038.
Phone:040 66493666, 9550381845, 9052626333,