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.

1.   Advance Certificate Program in Clinical Data Management (CRH-01)
  • Module 1: Introduction to Clinical Data Management
  • Module 2: Flow Chart of Clinical Data Management
  • Module 3: Roles and Responsibilities
  • Module 4: ICH-GCP Guidelines
  • Module 5: Data Analysis Software knowledge(MS Office and Excel,DBMS).
  • Module 6: Medical Coding,SAE Reconciliation ,and Advantages of CDM
  • Module 7: Clinical Data Interchange Standards Consortium
  • Module 8: Data Quality Management (DQM)
Minimum duration: 1 months & Maximum duration: 3 months
2.   Advance Certificate Program in clinical research and trial managment (CRH-02)
  • Module 1: Introduction to Pre-Clinical studies
  • Module 2:Introduction to Clinical Research and Phases
  • Module 3:Basic Introduction to key Pharma Companies in Clinical Research 
  • Module 4:Biostatistics- Concepts and Application in Clinical Research
  • Module 5: Guidelines (ICMR ,CIOMS ,ICH-GCP and WHO) 
  • Module 6: Stages of Clinical Trial Phases(0,II,III and IV)
  • Module 7:Protocol Writing and Designing: Industry Based Case Studies  
  • Module 8: Pharmacology Application in Clinical Trials
  • Module 9:Marketing Team Contributors in Clinical Research
  • Module 10: CRO and RA roles
  • Module 11: Institutional Review Board 
  • Module 12: Post Marketing Surveillance ( new product Introduction ,Branding                            
                               & Marketing.
Minimum duration: 3 months & Maximum duration: 6 months
  • Module 1:Drug Discovery Introduction and Drug Safety
  • Module 2: Introduction to pharmacovigilance  
  • Module 3: History of Pharmacovigilance 
  • Module 4:Biostatistics- Concepts and Application in Pharmacovigilance 
  • Module 5:Regulations Guiding the Pharmacological Studies.
  • Module 6:Introduction to Pharmacokinetics(what is the effect of drug on body).
  • Module 7:Introduction to  Pharmacodynamics(ADME : Absorption, Distribution,  Metabolism and Excretion) concept 
  • Module 8: Pharmacokinetics and Pharmacodynamics Relationship  
  • Module 9:Bioavailability and Volume of distribution
  • Module 10:Dose Response Curve , Functions, Tolerance and Factors Affecting
  • Module 11:Protocol Writing and Designing: Industry Based Case Studies  
  • Module 12: Pharmacology Application in Clinical Trials
Minimum duration: 3 months & Maximum duration: 6 months
  • Module 1: Introduction: Ethical Guidelines in Clinical Research 
  • Module 2: Good Clinical Practices ,ICH 
  • Module 3:Team Members of Ethical Committee
  • Module 4: Current Ethical Issues in Clinical Research 
  • Module 5:Important Guidelines ( ICMR,ICH-GCP,AYUSH,CTRI)
  • Module 6: Universal Ethical Requirements 
  • Module 7: Final Approval By CIOMS Collaborated with WHO .
  • Module 8: Med DRA Coding by Software 
Minimum duration: 1 months & Maximum duration: 3 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 Microbial Biotechnology and Its industrial application (BT-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
Program Code Indian Candidates (Rs.)   International Candidates(Dollar $)
  1 Month 3 Months 6 Months
CRH-01 Rs. 10000 (250 $) Rs. 15000 (400$) NIL
CRH-02 NIL Rs. 15000 (400$) Rs. 25000 (700$)
CRH-03 NIL Rs. 15000 (400$) Rs. 25000 (700$)
CRH-04 Rs. 10000 (250 $) Rs. 15000 (400$) NIL
CRH-05 NIL Rs. 15000 (400$) Rs. 25000 (700$)
CRH-06 NIL Rs. 15000 (400$) Rs. 25000 (700$)
CRH-07 NIL Rs. 15000 (400$) Rs. 25000 (700$)

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.


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.


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…

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Award of Certificate based on performance in Assignment


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

Step 2 - Completely fill application form and submit online.

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Name of the Account: Rapture Biotech International Pvt. Ltd.

Account Number: 2612431210

IFSC Code: KKBK0005033


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
IFSC Code:KKBK0005033

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