Clinserve , a non profit organisation offering a free training in following areas.
CLINICAL RESEARCH
CLINICAL DATA MANAGEMENT
SAS
PHARMACOVUGILANCE
REGULATORY AFFAIRS
INTELLECTUAL PROPERTY RIGHTS.
TO DOWN LOAD A BROCHURE/ COURSE CONTENT VISIT
www.clinserve.com
For more details,
call us @ 8977927530
mail us:
[email protected]
Hi All,
Looking for career in clinical data management then call us on 8977927530
clinserve, a non profit organisation provides services in the area of educational sector.
As part of the services ,we offer “ FREE TRAINING IN CLINICAL RESEARCH,SAS,CLINICAL DATA MANAGEMENT, PHARMACOVIGILANCE AND REGULATORY AFFAIRS”.
We are now focussing on training to generate great professionals in the mentioned sector.
If any one interested ,please call us or drop a mail to
[email protected]
or
[email protected]
We will cover all major topics as part our course curriculum.
Components of Part I :
Introduction to Clinical Research
• Basics of Clinical Trials & Clinical Research
• Terminologies & definition of Clinical Trials
• Types of Clinical research
• Phases of Clinical Research
• Good Clinical Practices
• Patient Recruitment
• Clinical Trial Statistics
• Bioavailability Studies
• Research Methodology
• Design of Experiments
• Clinical Trial Team
• Clinical Trial Regulatory Affairs
• Bioethics
Drug Development Process.
• Drug discovery
• Preclinical testing
• Clinical Development
History & Regulation in Clinical Research
ICH -GCP Guidelines - International Conference of Harmonization
• The principles of ICH GCP
• Institutional Review Board/Independent Ethics Committee (IRB/IEC)
• Investigator
• Sponsor
• Clinical trial protocol and protocol amendment (s)
• Investigator's brochure
• Essential documents for the conduct of a Clinical trial
SCHEDULE Y Drugs
Preparations & Planning for Clinical Trials
Essential Documentation in Clinical Research & Regulatory Submissions
Clinical Research Operations and Clinical Research Monitoring.
Regulatory Affairs, Good Clinical Practices and Ethics issues
Responsibility of Clinical Research Professionals.
21 CFR 11
Introduction to CDISC & CDASH
SDTM Implementation
Informed Consent Form
Protocol Development
Components of Part II :
Clinical Data Management
Introduction to Databases.•
Data Management Plan•
Study Set Up.•
( Electronic Data Capture.)
CRF Design.(Paper)•
e-•CRF Design
Open Clinica (Theory and Practical)•
Overview to Major Clinical Databases like oracle clinical ,clintrial,Inform,Medrio,rave…etc.
Components of Part III :
SAS 9.2
BASE/SAS
SAS/STAT
SAS/PROCEDURES
SAS/ACCESS
SAS/SQL
SAS/GRAPH
SAS/MACROS
SAS ENTERPRISE GUIDE4.1
Biostatistics for Clinical Trials
Components of Part IV:
Introduction to Pharmacovigilance
Importance of pharmacovigilance
Adverse Drug Reactions
Regulatory in Pharmacovigilamnce
ADR/causality Assessment
Narrative writing
Eligibility:
All Life Science Graduates, Doctors, Medical Professionals, Pharmacists etc.
B. Sc./ M. Sc. in Biotechnology, Microbiology, Genetics, Biochemistry or life sciences,M.B.B.S / B.D.S / B.A.M.S / B.H.M.S,B. Pharmacy/ M. Pharmacy, Graduates or Post Graduates in Nursing,B.E (BT) / B. Tech (BT)
We will help you in resume preparation and interview preparation.
+91-85588-96644
