Clinical Research
With this online /in-person practical training, you will be able to apply for Clinical Operations positions including:
- Clinical Research Associate (CRA)
- Clinical Research Assistant (CRA)
- Clinical Trial Analyst (CTA)
- Clinical Trial Coordinator (CTC)
- Clinical Trial Associate (CTA)
- Trial Manager File (TMF) Specialist
- CTMS Specialist
- Clinical Process Coordinator
| 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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Quick Enquiry
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Quick Links
INDIA
- Astakenis Clinical Research Institute,
- C-304, KSSIDC Complex I Block – 2nd Floor,Electronic City Phase I,
- Bengaluru, Karnataka 560100.
- Phone: +91 8185047315
- Email: info@astakenis.com
USA
- Astakenis Clinical Research Institute,
- 37600 Central Court,
- Suite 250E, Newark,
- CA 94560, USA.
- Phone: +1-209-992-3700
- Email: info@astakenis.com
Europe
- Astakenis Clinical Research Institute,
- Regus Tetra Hoofddorp,
- Siriusdreef 17-27,
- 2132 WT Hoofddorp,
- The Netherlands.
- Email: info@astakenis.com
UK
- Astakenis Clinical Research Institute,
- 27a, Green Lane,
- Northwood, Middlesex, HA6 2PX, United Kingdom.
- Email: info@astakenis.com
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