CliniLife is one of the best training providers of clinical research education and customized training to pharmaceuticals,CRO's ,professionals and universities.CliniLife has a unique training program in CLINICAL DATA MANAGEMENT.This program is designed for the professional who wants to transition into a CRA/CDC/Programmer position or enter the clinical research industry.
CliniLife innovative training methodology offers a comprehensive coverage of clinical research info and “Hands-On” Training of the clinical research process, the FDA regulations, the International Conference of Harmonization (ICH) and GCP (Good Clinical Practice) guidelines.
CliniLife offers the following courses to train the candidates in the field of Clinical Research & Clinical Data Management.
CliniLife offers E-learning program on Clinical Data Management. By using this facility students ,professionals from the industry can gain more knowledge on clinical domain. We offer excellent coaching through online with best quality. As most of our faculty got global exposure in this stream, it would be very helpful to the students abroad and the students in
as they will be globally exposed. India
CliniLife constitutes of a very highly skilled professionals who are from clinical research and pharmaceutical fields. They are experts and they are capable of explaining a concept to its last detail. CliniLife provides its students with excellent course material.
CliniLife offers ,
Module I :
Introduction to Clinical Research
· Basics of Clinical Trials & Clinical Research
· 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
· Clinical Trial Team
· Clinical Trial Regulatory Affairs
Drug Development Process.
· Drug discovery
· Preclinical testing
· Clinical Development
History & Regulation in Clinical Research
GCP Guidelines - International Conference of Harmonization
· The principles of ICH GCP
· Institutional Review Board/Independent Ethics Committee (IRB/IEC)
· 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
Informed Consent Form
Module II :
Clinical Data Management
Introduction to Databases.
Data Management Plan
Study Set Up.
EDC ( Electronic Data Capture.)
Open Clinica (Practical)
Oracle clinical ,RAVE (Overview)
Computer System Validation
Module III :
SAS ENTERPRISE GUIDE4.1
Biostatistics for Clinical Trials
Introduction to Pharmacovigilance
Importance of pharmacovigilance
Adverse Drug Reactions
Regulatory in Pharmacovigilamnce
Clinical quality Management
Clinical Project Management