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Industry Program in Clinical Trial, Research & Administration

Course Overview:

With the globalization of the pharmaceutical industry, increased use of medicines and public awareness of safety issues have come forth with the challenges in four areas of operations—organizational alignment, research & development , clinical trials data management, and risk & safety management. Thus in today’s biopharmaceutical product landscape, companies must be aware of crucial safety information about their products for which industry requires expertise and trained professionals in the domain related to clinical data management and safety monitoring department i.e. job profile like clinical data manager or Pharmacovigilance officer.

Course Objectives:

The main objective of this course is to develop experts/skilled professionals to handle large clinical data with correct spatial orientation of clinical research data management. The course will help participants to acquire a basic understanding of the concepts and practices of pharmacovigilance. 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 pharmacovigilance /clinical data management domain. The regulatory perspectives of clinical trials & Pharmacovigilance are the important part 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 pharmacovigilance and medical affairs team function and their dependency on data     management.

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 pharmacovigilance. 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 Pharmacovigilance and Data Management is bright for the sincere and diligent student and the working professional. Career opportunities in Pharmacovigilance includes:

  • Clinical Pharmacovigilance Officer.

  • Clinical Pharmacovigilance 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.

Admission Procedure:
  • Submission of Application.

  • Enclosures.

Eligibility: Any Science Graduate

Program Duration: The program duration is 12 months.

Course Modules:
  • Module I - Clinical Trials

  • Module II - Contract Research

  • Module III - Contract Research & Clinical or-S-V

  • Module IV -ICH-GCP Guidelines

  • Module V -ICMR- Guidelines on Biomedical Research on Human Subject

  • Module VI -Schedule-Y

  • Module VII -Biostatistics

  • Research Study

Program Fee:

BII Program Participation Fee for this program is Rs. 10,500 for participants based in India / USD 750 for Overseas participants.

Download the Application Form

Examination Fees:Every student has to pay Rs. 500 per module as examination fees. Examination fee for Overseas participants is USD 30 per module.

Download the Examination Form

Re-registration: Only once the candidate will be allowed to re-register himself for the course by paying the 50% of the course fee.

Download the Re-registration Form

Mode of Payment
Payment can be made through:
Demand Draft/Cheque in favor of Bioinformatics Institute of India at Delhi/Noida or NEFT.
NEFT (HDFC bank account details)
Account Name: Bioinformatics Institute of India
Bank Address: Sector 63 Gautam Budh Nagar Noida (U.P)
Current Account Number: 5020 0003 7096 35
IFSC Code: Hdfc0000975
MICR Code: 110240129
Branch Code: 000975

For further details and enquiries

Call: 0120-4320801/02
Mob: 09810535368,9818473366

Global Students for any queries


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