Training

CliniLife based in Hyderabad and working in the area of Life Science Education. CliniLife train the students in the area of Clinical Research, Bioinformatics and Applied Biotechnology. 

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. 

E-learning:

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 India as they will be globally exposed. 

Classroom learning:

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

· 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

Informed Consent Form

Protocol Development

Module II  :

Clinical Data Management

 Introduction to Databases.

 Data Management Plan

 Study Set Up.

 EDC ( Electronic Data Capture.)

 CRF Design.(Paper)

 e-CRF Design

 Open Clinica (Practical)

 LIFE CLINICAL

 Oracle clinical ,RAVE (Overview)

Computer System Validation

Module III  :

SAS 9.0/9.1

BASE/SAS

SAS/STAT

SAS/PROCEDURES

SAS/ACCESS

SAS/SQL

SAS/GRAPH

SAS/MACROS

SAS ENTERPRISE GUIDE4.1

Biostatistics for Clinical Trials

Module IV

Introduction to Pharmacovigilance

Importance of pharmacovigilance

Adverse  Drug Reactions

Regulatory  in Pharmacovigilamnce

ADR/causality  Assessment

Narrative writing

Clinical quality Management

Clinical Project Management