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Aims & Objectives
The main objective of this course is to develop experts/skilled professionals to perform clinical data management tasks by having a correct spatial orientation of clinical research data management. The course will help participants to acquire a basic understanding of the concepts and practice of pharmaco-vigilance.

The objectives of the course is to enable participants to understand issues surrounding the risks and benefits of drug used in humans including the cause, manifestations and consequences of adverse drug effects (ADEs).The aim of the course is to have thorough insight on project management related to pharmaco-vigilance /clinical data management domain .The regulatory perspectives of clinical trials & Pharmaco-vigilance are the important part of the course.

Course-Curriculum :
  • Module I : Pharmacovigilance, Risk Management & Compliance to Clinical Safety
  • Module II : Pharmacovigilance Regulation to Clinical Safety
  • Module III : Adverse Drug Reactions, Reporting & Signal Detection System
  • Module IV : Bio-statistical Analysis of Clinical Trials Data
  • Module V : Clinical Trials & Regulation Analysis
  • Module VI : Clinical Trials Data Management
  • Module VII : ICH-GCP Guidelines for Clinical Trials
  • Module VIII :Contract Research
  • Module IX :Assurance & Control of Pharmaceutics
  • Module X :Medical Writing & Documentation
  • Research Study
Benefits of the course :
After the successful completion of this program, Students would be able to:
  • Understand the regulatory perspectives on clinical research activities.
  • Understand the protocol/study design and the database set-up.
  • Perform database/procedure testing, data validation, SAE reconciliation and medical coding.
  • Have a thorough insight on project management in data management domain.
  • Understand how a pharmaco-vigilance and medical affairs team function and their dependency on data management.
Eligibility : Any Science Graduate
Career Opportunities :
The course caters to industry demands and moulds both fresher as well as experienced candidates to become exceptional professionals in the arena of clinical research and pharmaco-vigilance. The course also dwells on modulating invisible resources (communication-oral and written, decision-making, leadership qualities and time management skills) that would enable the participants to stand in a better stead than other candidates in the fiercely competitive job market. "Clinical data management" is a profession with increasing importance in product research and development process and is considered as an integral part of clinical trials. A career in both Pharmaco-vigilance and Data Management is bright for the sincere and diligent student and the working professional. Career opportunities in Pharmaco-vigilance includes as a
  • Clinical Pharmaco-vigilance Officer.
  • Clinical Pharmaco-vigilance Associate.
  • Regulatory Affairs Associate.
  • Clinical Drug Safety Associate and Clinical CRF Designer among others. For Data Management students, careers will be as Data Entry Operator, Research associates.
  • Data coordinators and statisticians.
  • Database Programmer.
  • Database designer.
  • Clinical data monitor.
  • QA/QC executive.
  • Project Manager.
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Established in 2002, Bioinformatics Institute of India (BII) is first of its kind with solely focusing on Bioinformatics and other applied life sciences courses.

BII is, resolute visionary, committed to provide world class technical and scientific education in life sciences courses. The aim behind the establishment of BII was to synergize theoretical knowledge and practical skills to promote all round professional competence due to which now BII has acquired a unique status in the country and globally.

Bioinformatics Institute of India (BII), set-up in the year 2002 has acquired international reputation by conducting industry oriented knowledge enhancement programs in the emerging domains of life science.Within a short span of a decade, BII has traversed many milestones in academic excellence and is today recognized as premier institute for providing the training in the area of Bioinformatics, Biotechnology, Pharmacy and Life Sciences. 
  • The course-curriculum has been designed on global industrial pattern to fill the gap between academia and industry has lead BII to attain professional expertise in the field of life science and its allied area.
Bioinformatics Institute of India (BII)
H- 109, SECTOR 63, NOIDA, NOIDA, DELHI NCR, India 201307
0120-4320801/802
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