Free Professional Courses : Clinical Research, SAS and CDM

Clinserve provides JOB ORIENTED PROFESSIONAL TRAINING in the area of CLINICAL RESEARCH.

CLINSERVE offer “ PROFESSIONAL TRAINING IN CLINICAL RESEARCH, SAS, CLINICAL DATA MANAGEMENT, PHARMACOVIGILANCE "

We will cover all major topics as part our course curriculum.

Module I: CLINICAL RESEARCH

Clinical Research Introduction
Principles of Pharmacology & Drug Discovery & Development
Research Methodology and Clinical Trials Designs
Phases of Drug Development Process
Terminologies & definition of Clinical Trials
. Types of Clinical research
• Phases of Clinical Research
• Features of Clinical Trials
• Good Clinical Trial Practices
• Patient Recruitment
• Clinical Trial Statistics
• Bioavailability Studies
• Research Methodology
• Design of Experiments
Good Clinical Practices
Regulations in Clinical Research
Clinical Trial At a Site
Responsibility of Clinical Research Professionals
Preparations & Planning for Clinical Trials
Essential Documentation in Clinical Research & Regulatory Submissions
Clinical Trials Project Planning & Management
Study Start Up Process
Clinical Monitoring Essentials
Compliance, Auditing & Quality Control in Clinical Research
Schedule Y Drugs
Clinical Research Operations and Clinical Research Monitoring.
Regulatory Affairs, Good Clinical Practices and Ethics issues
21 CFR 11
CDISC & CDASH
Informed Consent Document (ICD)
Protocol Development and amendment

Module II: CLINICAL DATA MANAGEMENT (CDM)
Elementary understanding of Clinical Data Management
CRF Design
CRF completion guidelines (CCG)
Clinical Database Types of databases
Electronic Data Capture
e-CRF Design
Tracking of Clinical data
Data entry, review
Identify/management of discrepancies
Edit checking, data validation specifications
User Acceptance Testing (UAT)
QA,QC
Hands on experience of OPEN CLINICA(End to End Data Management)
Overview to Oracle Clinical
Overview to Rave
Overview to Inform
Overview to Medrio
computer System validation
SQL (Structured Query Language)
Study setup

Module III: Pharmacovigilance
Introduction to Pharmacovigilance
Importance of pharmacovigilance
Adverse Drug Reactions
Regulatory in Pharmacovigilamnce
ADR/causality Assessment
Narrative writing
Pharmacovigilance workflow using ADR DB.

Module IV : SAS
• SAS 9.2
• SAS/BASE
• SAS/STAT
• SAS/PROCEDURES
• SAS/ACCESS
• SAS/SQL
• SAS/GRAPH
. SAS/MACROS
. SAS EG

Contact :
Clinserve
Balaji Nagar
Kukatpally
Near Kalyan Jewellers
Hyderabad-72

call : 8977927530,8977927540