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CLINICAL RESEARCH AND HEALTHCARE PROGRAM (CRH)

OVERVIEW:

Clinical Research Industry in an ever growing industry. The aim of the course is to prepare the candidate to have excell in the area of clinical research and pharmacovigilance with good standards and values and to develop skills in Clinical Research with clear understanding and complete knowledge of this industry and its working. It is an integrated program that will give you a methodical understanding of the key areas of drug development, clinical research processes, clinical trial management, and pharmacovigilance systems thus boosting your skills and knowledge to the level expected of a Clinical Research and Pharmacovigilance Professional. The new pharmaceutical or medical product are made available to the public, before they are thoroughly researched and tested by Clinical data managers. This Program focuses on data collection techniques and database management, including practical applications of database management in clinical research. Students examine electronic data transfer methods and quality assurance performance for accuracy. The Pharmaceutical and healthcare industry are deeply connected. This course introduces the basics of clinical research and healthcare management. It provides the core knowledge in clinical research and enables students to develop managerial skills to handle real-life business situations in the healthcare sector and with an in-depth understanding of the core areas of the Healthcare Management and enhances your skills and knowledge to the level expected of a Healthcare Executive. The course is meant for all those keen on being a part of Clinical Research industry.

PROGRAMS NAME:

1. Advance Certificate Program in Clinical Data Management (CRH-01)

  • Module 1: Introduction to Clinical Data Management
  • Module 2: Clinical data Management Plant
  • Module 3: Agenda of Data Management plan
  • Module 4: Fundamental of clinical trial software
  • Module 5: Good Clinical Research Practices
  • Module 6: Legal and ethical Issues in Database Management
Minimum duration: 3 months & Maximum duration: 6 months

2. Advance Certificate Program in Health Care Management (CRH-02)

  • Module 1: Introduction to Health Care Management
  • Module 2: Management in Healthcare
  • Module 3: Leadership in Healthcare
  • Module 4: Healthcare Financial Management
  • Module 5: Health Policy and System Research
  • Module 6: Health Care Assessment in Market
Minimum duration: 3 months & Maximum duration: 6 months

3. Advance Certificate Program in Clinical Pharmacology and Toxicology (CRH-03)

  • Module 1: Introduction to Pharmacology and Toxicology
  • Module 2: Pharmacokinetics and Toxicokinetics overview
  • Module 3: Application of the basic principles involved in distribution and elimination of toxicants
  • Module 4: Administration, liberation, and absorption of toxicants
  • Module 5: Prevention of absorption from the gastrointestinal tract
  • Module 6: Enhancement of elimination of toxicants
Minimum duration: 3 months & Maximum duration: 6 months

4. Diploma Certificate Program in Clinical Trial Research (CRH-04)

  • Module 1: Introduction to clinical trial research
  • Module 2: Clinical trials protocols, phases of clinical research.
  • Module 3: Monitoring of Clinical Trials
  • Module 4: Basic introduction to medical writing terminology
  • Module 5: Overview of drug development, regulation and sequence, clinicalbackground and drug discovery
  • Module 6: Pharmacological testing and pre-clinical research
  • Module 7: Writing of research reports, clinical trial report
  • Module 8: Good Clinical Practices (GCP)
Minimum duration: 3 months & Maximum duration: 6 months

5. Diploma Certificate Program in Clinical Trials Auditing and Inspection (CRH-05

  • Module 1: An Introduction of Quality
  • Module 2: Importance of quality in Clinical Trials
  • Module 3: Quality control and quality assurance in clinical research
  • Module 4: Audits Definition
  • Module 5: Different types of Audits
  • Module 6: Preparation of an Audit
  • Module 7: Conduct of an Audit
  • Module 8: Regulatory Inspections
  • Module 9: FDA
Minimum duration: 3 months & Maximum duration: 6 months

6. Diploma Certificate Program in ICH GCP Guidelines (CRH-06)

  • Module 1: Introduction to Clinical Research & Phases in Clinical Research
  • Module 2: The Principles of ICH GCP
  • Module 3: Sponsor responsibility
  • Module 4: Clinical trial protocol and protocol amendment(s)
  • Module 5: Standard Operating Procedures for Clinical Research
  • Module 6: Preparation of an Audit
  • Module 7: Conduct of an Audit
  • Module 8: Regulatory Inspections
  • Module 9: FDA
Minimum duration: 3 months & Maximum duration: 6 months

7. Diploma Certificate Program in Clinical Research and Pharmacovigilance (CRH-06)

  • Module 1:Clinical Research/Clinical Trial
  • Module 2:Guideline for Good Clinical Practice – ICH Harmonised Tripartite Guideline
  • Module 3: Statement of General Principles on Ethical Considerations involving Human Participants
  • Module 4: Clinical Trial Players and their Responsibilities
  • Module 5: Statistical Principles of Clinical Trial
  • Module 6: Quality Assurance of Clinical Trial
  • Module 7: Introduction to Pharmacovigilance
  • Module 8: Importance of Pharmacovigilance
  • Module 9: Designing a Pharmacovigilance System
  • Module 10: Pharmacovigilance Planning
  • Module 11: Pharmacovigilance Policies,Regulations and Guidance Documents
  • Module 12: Communication in Pharmacovigilance
Minimum duration: 3 months & Maximum duration: 6 months

ELIGIBILITY:

Persons pursuing or passed out of M.B.B.S/BDS/B.Sc./M.Sc./B.Tech/M.Tech/Ph.D in Biotechnology, Bioinformatics, Microbiology & other relevant Qualification in the respective areas are eligible.

EVALUATION AND AWARD CERTIFICATE:

At the end of the duration of a program, students go through a well-defined evaluation. Grades are given according to their performance in Assignment and then certificate is awarded.

JOB PROSPECTS:

Clinical Research and Healthcare program clear your all key concepts of clinical data management and give you a broad understanding of the role played by Clinical Rearch departments. A clinical data research associate or clinical data manager can work for various organizations in healthcare and pharmaceuticals. Companies hiring such professionals are pharmaceutical companies, biotechnology organizations, academic medical centers, hospitals, and government departments. There are wide openings in hospitals, healthcare centers and government institutions. Leading hospitals like escorts, Max healthcare, Fortis, Apollo, Artimis and Pharma companies engage healthcare management and clinical research students at various positions. Basically it is designed to highlight the candidate’s commitment to continual professional development and will ensure a competitive edge when applying for future employment positions. These professionals will find employment as:

  • Pharmacovigilance Manager
  • Drug Safety Specialist
  • Project Assistant
  • QA/QC executive
  • Project Manager
  • Clinical laboratory technician
  • Crime scene technician
  • Forensic Chemist
  • Biotechnology Consultant and MANY MORE…

EVALUATION & AWARD OF CERTIFICATE

Select Distance Learning Program of your choice



Fill online application form & Pay fees



Confirmation of admission & enrollment number



Dispatch of Course material



Download & submit Assignment



Evaluation



Award of Certificate based on performance in Assignment

HOW TO APPLY:

Step 1 - Click on “Apply Online Form” from the website.

Step 2 - Completely fill application form and submit online.

Step 3- Submit application fee using NEFT from anywhere in India.

Bank Name: Kotak Mahindra Bank, Sector-18 Noida
Name of the Account: Rapture Biotech International Pvt. Ltd.
Account Number: 2612431210
IFSC Code: KKBK0005033

OR

Submit fee using DD/Cheques. Should be Drawn In favour of Rapture Biotech payable at Noida and send it to "Rapture Biotech, D-201, Sector 10 Noida - 201301, Uttar Pradesh" by Speed Post/Registered Post.

(For International Students): Bank to Bank Transfer by Swift Mode

Bank Name: Kotak Mahindra Bank, Sec-18, Noida

Name of the Account: Rapture Biotech International Pvt Ltd Account Number: 2612431210 Swift Code: KKBKINBB IFSC Code: KKBK0005033

FOR FURTHER DETAILS AND ENQUIRIES

Tel: 0120- 4108608
Mobile: +91- 09910181655, 09027326396
E-mail: info@rapturebio.com, rapturebio@gmail.com

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