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Clinical Research

With this online /in-person practical training, you will be able to apply for Clinical Operations positions including:

S.no Theoretical Training
1
Drug Development Process
2
Definition, History, Overview and Basic terminologies of Clinical Research
3
Different Phases of clinical research – Phase 1 to 4
4
Bioavailability & Bio-equivalence Studies
5
Ethics and Ethical Guidelines for Clinical Trials and Good Clinical Practice (GCP)
6
Regulations Guiding the Clinical Research and International Regulatory Bodies
7
Role of Clinical Research Organization, Site Management and Monitoring in Clinical Research
8
Clinical Trial Documentation, Audits, and Inspections
9
Informed consent Process
10
Different types of trial design
11
Clinical trial documents
12
Definition & responsibility of Principal Investigator
13
Role of every other personnel in a clinical trial
14
Documentation and Data Management in Clinical Trials
15
Safety Reporting Techniques and Pharmacovigilance
16
Quality Control and Clinical Trial Management
17
Biostatistics- Concepts and Application in Drug Development and Clinical Research
18
Protocol Writing and Designing
S.no Practical Training using Clinevo CTMS and eTMF Platforms
1
CTMS Overview
2
Study, Site and Visits Setup
3
Subject Visits Scheduling and Tracking
4
Tasks, Milestones setup and tracking
5
Handling Protocol deviations
6
Site Monitoring Visits and Trip reports generation
7
eTMF System Overview
8
DIA eTMF standards
9
Planning and eTMF setup
10
Uploading and filing documents in an eTMF software

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